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B Oracle Health Sciences Clinical Development Analytics Presentation Catalog

The OHSCDA Presentation Catalog displays columns that you can use to create requests.

This appendix contains the following topics:

• Dimensions in OHSCDA Presentation Catalog

• Facts in OHSCDA Presentation Catalog

• Oracle Clinical Sources for OHSCDA Presentation Catalog

• Oracle's Siebel Clinical Sources for OHSCDA Presentation Catalog

• Oracle Health Sciences InForm Sources for OHSCDA Presentation Catalog

Dimensions in OHSCDA Presentation Catalog

Table B-1 describes the Dimensions displayed in the OHSCDA Presentation Catalog. For each column, it shows the name of the Column, its description, and the Dimension containing the column. The table is sorted by Dimension, and by Column within Dimension. This corresponds to how the Dimension columns are organized in the Presentation Catalog. Each Dimension column has an ID number, which is provided for cross-reference to other tables in this appendix.

Please note that some columns have been de-normalized, so that they appear in more than one Dimension. This de-normalization speeds query execution by eliminating the need for a join to that column in another Dimension. It also supports the ability to constrain columns in a Prompt, so that when you select a value in one column, the other columns are constrained to those related to your selection. When you select a de-normalized column from a Dimension, your results will be limited to the grain of the Dimension.

Table B-1 Presentation Catalog - Dimensions

ID	Dimension	Column	Description
AD02	Time - All purpose Date	-	Time series based on Subject Status Date, Document Received Date, Site Visit Completed Date, Follow Up Item Completed Date, Discrepancy Creation Date, CRF Entry Date
AD02-07	Time - All purpose Date	Date	Calendar Date
AD02-02	Time - All purpose Date	Julian Day	Julian Day
AD02-08	Time - All purpose Date	Julian Month	Julian Month
AD02-09	Time - All purpose Date	Julian Week	Julian Week
AD02-03	Time - All purpose Date	Month	Month within calendar year
AD02-10	Time - All purpose Date	Month Name	Full name of the month
AD02-04	Time - All purpose Date	Quarter	Quarter within calendar year
AD02-06	Time - All purpose Date	Week	Week within calendar year
AD02-05	Time - All purpose Date	Year	Calendar year
AD02-11	Time - All purpose Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-13	Time - All purpose Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-12	Time - All purpose Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - 1st Site Initiated Date	-	Time series based on 1st Site Initiated Date
AD02-134	Time - 1st Site Initiated Date	Date	Calendar Date
AD02-135	Time - 1st Site Initiated Date	Julian Day	Julian Day
AD02-136	Time - 1st Site Initiated Date	Julian Month	Julian Month
AD02-137	Time - 1st Site Initiated Date	Julian Week	Julian Week
AD02-138	Time - 1st Site Initiated Date	Month	Month within calendar year
AD02-139	Time - 1st Site Initiated Date	Month Name	Full name of the month
AD02-140	Time - 1st Site Initiated Date	Quarter	Quarter within calendar year
AD02-141	Time - 1st Site Initiated Date	Week	Week within calendar year
AD02-142	Time - 1st Site Initiated Date	Year	Calendar year
AD02-143	Time - 1st Site Initiated Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-144	Time - 1st Site Initiated Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
-	Time - 1st Site Initiated Date	-	-
AD02-145	Time - 1st Site Initiated Date	Year and Week	Year and week (ex. 1994 Week10)
AD02-146	Time - 1st Subject Enrolled Date	Date	Calendar Date
AD02-147	Time - 1st Subject Enrolled Date	Julian Day	Julian Day
AD02-148	Time - 1st Subject Enrolled Date	Julian Month	Julian Month
AD02-149	Time - 1st Subject Enrolled Date	Julian Week	Julian Week
AD02-150	Time - 1st Subject Enrolled Date	Month	Month within calendar year
AD02-151	Time - 1st Subject Enrolled Date	Month Name	Full name of the month
AD02-152	Time - 1st Subject Enrolled Date	Quarter	Quarter within calendar year
AD02-153	Time - 1st Subject Enrolled Date	Week	Week within calendar year
AD02-154	Time - 1st Subject Enrolled Date	Year	Calendar year
AD02-155	Time - 1st Subject Enrolled Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-156	Time - 1st Subject Enrolled Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-157	Time - 1st Subject Enrolled Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Discrepancy Close Date	-	Time series based on Discrepancy Close Date
AD02-79	Time - Discrepancy Close Date	Date	Calendar Date
AD02-74	Time - Discrepancy Close Date	Julian Day	Julian Day
AD02-80	Time - Discrepancy Close Date	Julian Month	Julian Month
AD02-81	Time - Discrepancy Close Date	Julian Week	Julian Week
AD02-75	Time - Discrepancy Close Date	Month	Month within calendar year
AD02-82	Time - Discrepancy Close Date	Month Name	Full name of the month
AD02-76	Time - Discrepancy Close Date	Quarter	Quarter within calendar year
AD02-78	Time - Discrepancy Close Date	Week	Week within calendar year
AD02-77	Time - Discrepancy Close Date	Year	Calendar year
AD02-83	Time - Discrepancy Close Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-85	Time - Discrepancy Close Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-84	Time - Discrepancy Close Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Document Expiration Date	-	Time series based on Document Expiration Date
AD02-19	Time - Document Expiration Date	Date	Calendar Date
AD02-14	Time - Document Expiration Date	Julian Day	Julian Day
AD02-20	Time - Document Expiration Date	Julian Month	Julian Month
AD02-21	Time - Document Expiration Date	Julian Week	Julian Week
AD02-15	Time - Document Expiration Date	Month	Month within calendar year
AD02-22	Time - Document Expiration Date	Month Name	Full name of the month
AD02-16	Time - Document Expiration Date	Quarter	Quarter within calendar year
AD02-18	Time - Document Expiration Date	Week	Week within calendar year
AD02-17	Time - Document Expiration Date	Year	Calendar year
AD02-23	Time - Document Expiration Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-25	Time - Document Expiration Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-24	Time - Document Expiration Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Document Sent Date	-	Time series based on Document Sent Date
AD02-31	Time - Document Sent Date	Date	Calendar Date
AD02-26	Time - Document Sent Date	Julian Day	Julian Day
AD02-32	Time - Document Sent Date	Julian Month	Julian Month
AD02-33	Time - Document Sent Date	Julian Week	Julian Week
AD02-27	Time - Document Sent Date	Month	Month within calendar year
AD02-34	Time - Document Sent Date	Month Name	Full name of the month
AD02-28	Time - Document Sent Date	Quarter	Quarter within calendar year
AD02-30	Time - Document Sent Date	Week	Week within calendar year
AD02-29	Time - Document Sent Date	Year	Calendar year
AD02-35	Time - Document Sent Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-37	Time - Document Sent Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-36	Time - Document Sent Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Most Recent Approved Date	-	Time series based on Most Recent Approved Date
AD02-91	Time - Most Recent Approved Date	Date	Calendar Date
AD02-86	Time - Most Recent Approved Date	Julian Day	Julian Day
AD02-92	Time - Most Recent Approved Date	Julian Month	Julian Month
AD02-93	Time - Most Recent Approved Date	Julian Week	Julian Week
AD02-87	Time - Most Recent Approved Date	Month	Month within calendar year
AD02-94	Time - Most Recent Approved Date	Month Name	Full name of the month
AD02-88	Time - Most Recent Approved Date	Quarter	Quarter within calendar year
AD02-90	Time - Most Recent Approved Date	Week	Week within calendar year
AD02-89	Time - Most Recent Approved Date	Year	Calendar year
AD02-95	Time - Most Recent Approved Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-97	Time - Most Recent Approved Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-96	Time - Most Recent Approved Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Most Recent Source Verification Date	-	Time series based on Most Recent Source Verification Date
AD02-103	Time - Most Recent Source Verification Date	Date	Calendar Date
AD02-98	Time - Most Recent Source Verification Date	Julian Day	Julian Day
AD02-104	Time - Most Recent Source Verification Date	Julian Month	Julian Month
AD02-105	Time - Most Recent Source Verification Date	Julian Week	Julian Week
AD02-99	Time - Most Recent Source Verification Date	Month	Month within calendar year
AD02-106	Time - Most Recent Source Verification Date	Month Name	Full name of the month
AD02-100	Time - Most Recent Source Verification Date	Quarter	Quarter within calendar year
AD02-102	Time - Most Recent Source Verification Date	Week	Week within calendar year
AD02-101	Time - Most Recent Source Verification Date	Year	Calendar year
AD02-107	Time - Most Recent Source Verification Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-109	Time - Most Recent Source Verification Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-108	Time - Most Recent Source Verification Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Pass 1 Completion Date	-	Time series based on Pass 1 Completion Date
AD02-115	Time - Pass 1 Completion Date	Date	Calendar Date
AD02-110	Time - Pass 1 Completion Date	Julian Day	Julian Day
AD02-116	Time - Pass 1 Completion Date	Julian Month	Julian Month
AD02-117	Time - Pass 1 Completion Date	Julian Week	Julian Week
AD02-111	Time - Pass 1 Completion Date	Month	Month within calendar year
AD02-118	Time - Pass 1 Completion Date	Month Name	Full name of the month
AD02-112	Time - Pass 1 Completion Date	Quarter	Quarter within calendar year
AD02-114	Time - Pass 1 Completion Date	Week	Week within calendar year
AD02-113	Time - Pass 1 Completion Date	Year	Calendar year
AD02-119	Time - Pass 1 Completion Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-121	Time - Pass 1 Completion Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-120	Time - Pass 1 Completion Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Pass 2 Completion Date	-	Time series based on Pass 2 Completion Date
AD02-127	Time - Pass 2 Completion Date	Date	Calendar Date
AD02-122	Time - Pass 2 Completion Date	Julian Day	Julian Day
AD02-128	Time - Pass 2 Completion Date	Julian Month	Julian Month
AD02-129	Time - Pass 2 Completion Date	Julian Week	Julian Week
AD02-123	Time - Pass 2 Completion Date	Month	Month within calendar year
AD02-130	Time - Pass 2 Completion Date	Month Name	Full name of the month
AD02-124	Time - Pass 2 Completion Date	Quarter	Quarter within calendar year
AD02-126	Time - Pass 2 Completion Date	Week	Week within calendar year
AD02-125	Time - Pass 2 Completion Date	Year	Calendar year
AD02-131	Time - Pass 2 Completion Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-133	Time - Pass 2 Completion Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-132	Time - Pass 2 Completion Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Site Visit Start Date	-	Time series based on Site Visit Start Date
AD02-43	Time - Site Visit Start Date	Date	Calendar Date
AD02-38	Time - Site Visit Start Date	Julian Day	Julian Day
AD02-44	Time - Site Visit Start Date	Julian Month	Julian Month
AD02-45	Time - Site Visit Start Date	Julian Week	Julian Week
AD02-39	Time - Site Visit Start Date	Month	Month within calendar year
AD02-46	Time - Site Visit Start Date	Month Name	Full name of the month
AD02-40	Time - Site Visit Start Date	Quarter	Quarter within calendar year
AD02-42	Time - Site Visit Start Date	Week	Week within calendar year
AD02-41	Time - Site Visit Start Date	Year	Calendar year
AD02-47	Time - Site Visit Start Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-49	Time - Site Visit Start Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-48	Time - Site Visit Start Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Visit Report Approved Date	-	Time series based on Visit Report Approved Date
AD02-67	Time - Visit Report Approved Date	Date	Calendar Date
AD02-62	Time - Visit Report Approved Date	Julian Day	Julian Day
AD02-68	Time - Visit Report Approved Date	Julian Month	Julian Month
AD02-69	Time - Visit Report Approved Date	Julian Week	Julian Week
AD02-63	Time - Visit Report Approved Date	Month	Month within calendar year
AD02-70	Time - Visit Report Approved Date	Month Name	Full name of the month
AD02-64	Time - Visit Report Approved Date	Quarter	Quarter within calendar year
AD02-66	Time - Visit Report Approved Date	Week	Week within calendar year
AD02-65	Time - Visit Report Approved Date	Year	Calendar year
AD02-71	Time - Visit Report Approved Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-73	Time - Visit Report Approved Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-72	Time - Visit Report Approved Date	Year and Week	Year and week (ex. 1994 Week10)
-	Time - Visit Report Completed Date	-	Time series based on Visit Report Completed Date
AD02-55	Time - Visit Report Completed Date	Date	Calendar Date
AD02-50	Time - Visit Report Completed Date	Julian Day	Julian Day
AD02-56	Time - Visit Report Completed Date	Julian Month	Julian Month
AD02-57	Time - Visit Report Completed Date	Julian Week	Julian Week
AD02-51	Time - Visit Report Completed Date	Month	Month within calendar year
AD02-58	Time - Visit Report Completed Date	Month Name	Full name of the month
AD02-52	Time - Visit Report Completed Date	Quarter	Quarter within calendar year
AD02-54	Time - Visit Report Completed Date	Week	Week within calendar year
AD02-53	Time - Visit Report Completed Date	Year	Calendar year
AD02-59	Time - Visit Report Completed Date	Year and Month	Year and month (ex. 1994 / 02)
AD02-61	Time - Visit Report Completed Date	Year and Quarter	Year and quarter (ex. 1994 Q1)
AD02-60	Time - Visit Report Completed Date	Year and Week	Year and week (ex. 1994 Week10)
AD11	CRF	-	A Case Report Form. This is the form itself, as defined in a study, and which is assigned to be collected at various subject visits during a study.
AD11-02	CRF	CRF Name	Name of the form.
AD11-04	CRF	CRF Short Name	Short name of the form
AD11-05	CRF	DCI_ID	Oracle Clinical ID for the form.
AD11-03	CRF	Description	Free text description of the particular CRF
AD11-01	CRF	Study	Study in which the form is specified.
AD12	CRF Book	-	A specification of which CRFs are to be collected at what subject visits
AD12-01	CRF Book	CRF Book Name	Case Report Form Book (a set of forms to be collected, organized by visit): name of the book
AD12-02	CRF Book	Study	Case Report Form Book (a set of forms to be collected, organized by visit): study in which the book is to be used
AD4	Geography	-	Location of a site, in terms of a fixed hierarchy. State >- Country >- Continent.
AD04-06	Geography	City	City
AD04-01	Geography	Continent	Continent
AD04-03	Geography	Country	Country
AD04-05	Geography	County or District	County or District
AD04-07	Geography	Postal Code	Postal Code
AD04-04	Geography	State or Province	State or Province
AD5	Investigator	-	Attributes of an Investigator, who may participate in multiple studies.
AD05-19	Investigator	Investigator Action Link	Action Link for Siebel Clinical Contacts. Can be used to link back to Contact record in Siebel Clinical
AD05-11	Investigator	Investigator Business Unit	Organizational business unit
AD05-05	Investigator	Investigator City	The city where the investigator is located.
AD05-09	Investigator	Investigator Continent	Continent where the investigator is located
AD05-08	Investigator	Investigator Country	Country where the investigator is located
AD05-13	Investigator	Investigator Email Address	Investigator email address
AD05-14	Investigator	Investigator Fax/Phone #	Investigator fax/phone number
AD05-02	Investigator	Investigator First Name	Investigator's given name
AD05-03	Investigator	Investigator Full Name	Last name, then first name
AD05-01	Investigator	Investigator Last Name	Investigator's surname
AD05-15	Investigator	Investigator Middle Name	Investigator middle name
AD05-12	Investigator	Investigator Mobile #	Investigator mobile number
AD05-06	Investigator	Investigator Postal code	Postal code
AD05-07	Investigator	Investigator State	The state where the investigator is located
AD05-04	Investigator	Investigator Street Address	Investigator's street address
AD05-17	Investigator	Investigator Street Address 2	Investigator's street address - 2nd line
AD05-18	Investigator	Investigator Street Address 3	Investigator's street address - 3rd line
AD05-16	Investigator	Investigator Type	Investigator type
AD05-10	Investigator	Investigator Work Phone	Investigator's work telephone
-	Overall Level Targets	-	-
AD18-01	Overall Level Targets	[Expected % Sites Recruiting 0 Subjects]	The Expected % Sites Recruiting 0 Subjects for all studies.
AD18-16	Overall Level Targets	[Program RACT Score Lower Threshold]	The lower threshold for identifying whether a Program RACT Score is High, Medium or Low. RACT scores above or equal to this threshold are considered ”Medium” risk. RACT scores below this threshold are considered ”Low” risk.
AD18-15	Overall Level Targets	[Program RACT Score Upper Threshold]	The upper threshold for identifying whether a Program RACT Score is High, Medium or Low. RACT scores above or equal to this threshold are considered ”High” risk.
AD18-14	Overall Level Targets	[RACT Category Score Lower Threshold]	The lower threshold for identifying whether a RACT Category Score is High, Medium or Low. Category scores above or equal to this threshold are considered ”Medium” risk. Category scores below this threshold are considered ”Low” risk.
AD18-13	Overall Level Targets	[RACT Category Score Upper Threshold]	The upper threshold for identifying whether a RACT Category Score is High, Medium or Low. Category scores above or equal to this threshold are considered ”High” risk.
AD18-18	Overall Level Targets	[Study RACT Score Lower Threshold]	The lower threshold for identifying whether a Study RACT Score is High, Medium or Low. RACT scores above or equal to this threshold are considered ”Medium” risk. RACT scores below this threshold are considered ”Low” risk.
AD18-17	Overall Level Targets	[Study RACT Score Upper Threshold]	The upper threshold for identifying whether a Study RACT Score is High, Medium or Low. RACT scores above or equal to this threshold are considered ”High” risk.
AD18-20	Overall Level Targets	[Study-Region RACT Score Lower Threshold]	The lower threshold for identifying whether a Study-Region RACT Score is High, Medium or Low. RACT scores above or equal to this threshold are considered ”Medium” risk. RACT scores below this threshold are considered ”Low” risk.
AD18-19	Overall Level Targets	[Study-Region RACT Score Upper Threshold]	The upper threshold for identifying whether a Study-Region RACT Score is High, Medium or Low. RACT scores above or equal to this threshold are considered ”High” risk.
AD18-22	Overall Level Targets	[Study-Site RACT Score Lower Threshold]	The lower threshold for identifying whether a Study-Site RACT Score is High, Medium or Low. RACT scores above or equal to this threshold are considered ”Medium” risk. RACT scores below this threshold are considered ”Low” risk.
AD18-21	Overall Level Targets	[Study-Site RACT Score Upper Threshold]	The upper threshold for identifying whether a Study-Site RACT Score is High, Medium or Low. RACT scores above or equal to this threshold are considered ”High” risk.
AD18-10	Overall Level Targets	[Target Critical Document Package Complete to Site Initiated (# Days)]	The Target Critical Document Package Complete to Site Initiated (# Days) for all studies.
AD18-02	Overall Level Targets	[Target Last Subject Last Visit to Database Lock (# Days)]	The Target Last Subject Last Visit to Database Lock (# Days) for all studies.
AD18-03	Overall Level Targets	[Target Protocol Approved to 1st Site Initiated (# Days)]	The Target Protocol Approved to 1st Site Initiated (# Days) for all studies.
AD18-04	Overall Level Targets	[Target Protocol Approved to 1st Subject Enrolled (# Days)]	The Target Protocol Approved to 1st Subject Enrolled (# Days) for all studies.
AD18-11	Overall Level Targets	[Target Protocol Approved to 1st Subject Randomized (# Days)]	The Target Protocol Approved to 1st Subject Randomized (# Days) for all studies.
AD18-12	Overall Level Targets	[Target Protocol Approved to 1st Subject Screened (# Days)]	The Target Protocol Approved to 1st Subject Screened (# Days) for all studies.
AD18-05	Overall Level Targets	[Target Site Visit Completed to Follow Up Item Completed (# Days)]	The Target Site Visit Completed to Follow Up Item Completed (# Days) for all studies.
AD18-06	Overall Level Targets	[Target Site Visit Completed to Visit Report Approved (# Days)]	The Target Site Visit Completed to Visit Report Approved (# Days) for all studies.
AD18-07	Overall Level Targets	[Target Site Visit Completed to Visit Report Completed (# Days)]	The Target Site Visit Completed to Visit Report Completed (# Days) for all studies.
AD18-09	Overall Level Targets	[Target Site Visit Start to Site Visit Completed (# Days)]	The Target Site Visit Start to Site Visit Completed (# Days) for all studies.
AD18-08	Overall Level Targets	[Target Visit Report Completed to Visit Report Approved (# Days)]	The Target Visit Report Completed to Visit Report Approved (# Days) for all studies.
AD7	Product	-	Product dimension
AD07-04	Product	Description	Product Description
AD07-09	Product	Product Action Link	Action Link for Siebel Clinical Product to link back to Product record in Siebel Clinical
AD07-01	Product	Product Name	Name of the product
AD07-07	Product	Product Number	Product #
AD07-08	Product	Product Status	Product Status
AD07-02	Product	Product Type	Type of the product
AD07-03	Product	Product Type Code	Organization's type code for the product
AD16	Program	-	Program
AD16-05	Program	[Expected % Sites Recruiting 0 Subjects]	The Expected % Sites Recruiting 0 Subjects for the Program.
AD16-02	Program	Program	Program Name
AD16-04	Program	Program Action Link	Action Link for Siebel Clinical Program. Can be used to link back to Program record in Siebel Clinical
AD16-01	Program	Program Description	Program Description
AD16-03	Program	Program Mechanism	Program Mechanism
AD16-17	Program	RACT Template Name	Name of the Template that was used for this RACT.
AD16-18	Program	RACT Completed Date	Date that the RACT was completed.
AD16-20	Program	RACT Description	Description of the RACT.
AD16-19	Program	RACT Name	Name of the RACT.
AD16-21	Program	RACT Score	Total Risk score calculated from the RACT questions.
AD16-06	Program	[Target Critical Document Package Complete to Site Initiated (# Days)]	The Target Critical Document Package Complete to Site Initiated (# Days) for the Program.
AD16-07	Program	[Target Last Subject Last Visit to Database Lock (# Days)]	The Target Last Subject Last Visit to Database Lock (# Days) for the Program.
AD16-08	Program	[Target Protocol Approved to 1st Site Initiated (# Days)]	The Target Protocol Approved to 1st Site Initiated (# Days) for the Program.
AD16-09	Program	[Target Protocol Approved to 1st Subject Enrolled (# Days)]	The Target Protocol Approved to 1st Subject Enrolled (# Days) for the Program.
AD16-10	Program	[Target Protocol Approved to 1st Subject Randomized (# Days)]	The Target Protocol Approved to 1st Subject Randomized (# Days) for the Program.
AD16-11	Program	[Target Protocol Approved to 1st Subject Screened (# Days)]	The Target Protocol Approved to 1st Subject Screened (# Days) for the Program.
AD16-12	Program	[Target Site Visit Completed to Follow Up Item Completed (# Days)]	The Target Site Visit Completed to Follow Up Item Completed (# Days) for the Program.
AD16-13	Program	[Target Site Visit Completed to Visit Report Approved (# Days)]	The Target Site Visit Completed to Visit Report Approved (# Days) for the Program.
AD16-14	Program	[Target Site Visit Completed to Visit Report Completed (# Days)]	The Target Site Visit Completed to Visit Report Completed (# Days) for the Program.
AD16-15	Program	[Target Site Visit Start to Site Visit Completed (# Days)]	The Target Site Visit Start to Site Visit Completed (# Days) for the Program.
AD16-16	Program	[Target Visit Report Completed to Visit Report Approved (# Days)]	The Target Visit Report Completed to Visit Report Approved (# Days) for the Program.
AD23-01	RACT Category	[Functional Plan(s) Impacted]	The Functional Plan(s) that may be impacted if the RACT Category has a high risk score.
AD23-02	RACT Category	[Mitigation / Comments]	Any mitigations for the category risk or any comments about the category.
AD23-03	RACT Category	Name	The name of the RACT Category.
AD23-04	RACT Category	[Number]	The number of the RACT Category.
AD23-05	RACT Category	[Objective]	The objective of the category.
AD23-07	RACT Category	[Weight]	The weight this category is given when calculating the overall risk score.
AD17	Study-Region	-	Study Region
AD20-05	Region	[Expected % Sites Recruiting 0 Subjects]	The Expected % Sites Recruiting 0 Subjects for the Region.
AD20-06	Region	[Target Critical Document Package Complete to Site Initiated (# Days)]	The Target Critical Document Package Complete to Site Initiated (# Days) for the Region.
AD20-01	Region	[Target Site Visit Completed to Follow Up Item Completed (# Days)]	The Target Site Visit Completed to Follow Up Item Completed (# Days) for the Region.
AD20-03	Region	[Target Site Visit Completed to Visit Report Approved (# Days)]	The Target Site Visit Completed to Visit Report Approved (# Days) for the Region.
AD20-02	Region	[Target Site Visit Completed to Visit Report Completed (# Days)]	The Target Site Visit Completed to Visit Report Completed (# Days) for the Region.
AD20-08	Region	[Target Site Visit Start to Site Visit Completed (# Days)]	The Target Site Visit Start to Site Visit Completed (# Days) for the Region.
AD20-04	Region	[Target Visit Report Completed to Visit Report Approved (# Days)]	The Target Visit Report Completed to Visit Report Approved (# Days) for the Region.
AD20-07	Region	Region Name	The Region name.
AD08	Site	-	Site attributes
AD08-05	Site	Business Unit	Business Unit to which this Site belongs
AD08-12	Site	City	Site City
AD08-04	Site	Continent	Continent in which the Site is located
AD08-03	Site	Country	Country in which the Site is located
AD08-11	Site	County	Site County
AD08-10	Site	Postal Code	Site Postal Code
AD08-06	Site	Site Action Link	Action Link for Siebel Clinical Accounts. Can be used to link back to Account record in Siebel Clinical
AD08-01	Site	Site Name	Name of the Site
AD08-02	Site	State	State in which the Site is located
AD08-07	Site	Street Address	Site address line 1
AD08-08	Site	Street Address 2	Site address line 2
AD08-09	Site	Street Address 3	Site address line 3
TA-SIV	Site Visit	-	Site Visit attributes
TA-SIV11	Site Visit	Site Visit Action Link	Action Link for Siebel Clinical Site Visits. Can be used to link back to Site Visit record in Siebel Clinical
TA-SIV01	Site Visit	Site Visit Comments	Comments about the Site Visit
TA-SIV02	Site Visit	Site Visit Completed Date	Site Visit Completed Date field
TA-SIV03	Site Visit	Site Visit Name	The visit name field in the source system.
TA-SIV04	Site Visit	[Site Visit Report Approved Date]	Site Visit Report Approved Date field
TA-SIV15	Site Visit	Site Visit Report Approver	Name of the person who approved the Site Visit report.
TA-SIV05	Site Visit	Site Visit Report Completed Date	Visit Report Completed Date field
TA-SIV12	Site Visit	Site Visit Report Reviewed Date	Date the Site Visit Report was reviewed.
TA-SIV14	Site Visit	Site Visit Report Reviewer	Name of the person who reviewed the Site Visit report.
TA-SIV13	Site Visit	Site Visit Report Reviewer Comments	Comments on the Site Visit report made by the reviewer.
TA-SIV06	Site Visit	Site Visit Report Status	Visit Report Status field
TA-SIV10	Site Visit	Site Visit Report Template	The template selected to create a site visit report in the source system.
TA-SIV07	Site Visit	Site Visit Start Date	Site Visit Start Date field
TA-SIV08	Site Visit	Site Visit Status	Site Visit Status field
TA-SIV09	Site Visit	Site Visit Type	Site Visit Type field
AD9	Study	-	A description of the study
AD09-26	Study	[Clinical Study Report Date]	The Clinical Study Report Date for the Study.
AD09-07	Study	Comparative Agent	Comparative Agent
AD09-06	Study	Data Capture Mode	The mode of doing data entry in this study. Possible values are {'EDC' | 'Paper' | 'Paper and EDC' | 'Unknown'}
AD09-14	Study	Database Lock Date	Database lock date
AD09-08	Study	Diagnosis	Diagnosis
AD09-09	Study	EUDRA Number	EUDRA Number
AD09-82	Study	[Max Age Unit]	The Age Unit for the upper limit for age of subjects as defined in the protocol (Maximum Age of Subjects.
AD09-81	Study	[Maximum Age of Subjects]	The upper limit for age of subjects as defined in the protocol.
AD09-84	Study	[Min Age Unit]	The Age Unit for the lower limit for age of subjects as defined in the protocol (Minimum Age of Subjects.
AD09-83	Study	[Minimum Age of Subjects]	The lower limit for age of subjects as defined in the protocol.
AD09-35	Study	[Expected % Sites Recruiting 0 Subjects]	The Expected % Sites Recruiting 0 Subjects for the Study.
AD09-73	Study	[Expected Early Termination Rate]	The expected early termination rate for the Study.
AD09-45	Study	[Expected Retention Rate]	The Expected Retention Rate for the Study.
AD09-24	Study	[Expected Screen Failure Rate]	The Expected Screen Failure Rate for the Study.
AD09-87	Study	[Study Budget Source]	The entity (line, BU, governance, and so on) providing funds in support of the project.
AD09-88	Study	[Study Finance Code]	The finance code assigned to the study.
AD09-19	Study	[Protocol Approved Date]	The Protocol Approved Date for the Study.
AD09-69	Study	[Planned LE 1st Critical Document Package Completed Date]	The Planned LE 1st Critical Document Package Completed Date for the Study.
AD09-52	Study	[Planned LE 1st Initial IRB/EC Approval Date]	The latest estimate of the Planned 1st Initial IRB/EC Approval Date for the Study.
AD09-53	Study	[Planned LE 1st IRB/EC Submission Date]	The latest estimate of the Planned 1st IRB Submission Date for the Study.
AD09-54	Study	[Planned LE 1st Site Initiated Date]	The latest estimate of the Planned 1st Site Initiated Date for the Study.
AD09-55	Study	[Planned LE 1st Subject 1st Visit Date]	The latest estimate of the Planned 1st Subject 1st Visit Date for the Study.
AD09-56	Study	[Planned LE 1st Subject Enrolled Date]	The latest estimate of the Planned 1st Subject Enrolled Date for the Study.
AD09-57	Study	[Planned LE 1st Subject Randomized Date]	The latest estimate of the Planned 1st Subject Randomized Date for the Study.
AD09-58	Study	[Planned LE 1st Subject Screened Date]	The latest estimate of the Planned 1st Subject Screened Date for the Study.
AD09-59	Study	[Planned LE Clinical Study Report Date]	The latest estimate of the Planned Clinical Study Report Date for the Study.
AD09-60	Study	[Planned LE Database Lock Date]	The latest estimate of the Planned Database Lock Date for the Study.
AD09-61	Study	[Planned LE Last Critical Document Package Completed Date]	The latest estimate of the Planned Last Critical Document Package Completed Date for the Study.
AD09-62	Study	[Planned LE Last Site Initiated Date]	The latest estimate of the Planned Last Site Initiated Date for the Study.
AD09-63	Study	[Planned LE Last Subject 1st Visit Date]	The latest estimate of the Planned Last Subject 1st Visit Date for the Study.
AD09-64	Study	[Planned LE Last Subject Enrolled Date]	The latest estimate of the Planned Last Subject Enrolled Date for the Study.
AD09-65	Study	[Planned LE Last Subject Last Visit Date]	The latest estimate of the Planned Last Subject Last Visit Date for the Study.
AD09-66	Study	[Planned LE Last Subject Randomized Date]	The latest estimate of the Planned Last Subject Randomized Date for the Study.
AD09-67	Study	[Planned LE Protocol Approval Date]	The latest estimate of the Planned Protocol Approval Date for the Study.
AD09-48	Study	[Planned 1st Critical Document Package Completed Date]	The Planned 1st Critical Document Package Completed Date for the Study.
AD09-36	Study	[Planned 1st Initial IRB/EC Approval Date]	The Planned 1st Initial IRB/EC Approval Date for the Study.
AD09-50	Study	[Planned 1st IRB/EC Submission Date]	The Planned 1st IRB Submission Date for the Study.
AD09-49	Study	[Planned 1st Site Initiated Date]	The Planned 1st Site Initiated Date for the Study.
AD09-40	Study	[Planned 1st Subject 1st Visit Date]	The Planned 1st Subject 1st Visit Date for the Study.
AD09-46	Study	[Planned 1st Subject Enrolled Date]	The Planned 1st Subject Enrolled Date for the Study.
AD09-38	Study	[Planned 1st Subject Randomized Date]	The Planned 1st Subject Randomized Date for the Study.
AD09-39	Study	[Planned 1st Subject Screened Date]	The Planned 1st Subject Screened Date for the Study.
AD09-25	Study	[Planned Clinical Study Report Date]	The Planned Clinical Study Report Date for the Study.
AD09-20	Study	[Planned Database Lock Date]	The Planned Database Lock Date for the Study.
AD09-51	Study	[Planned Last Critical Document Package Completed Date]	The Planned Last Critical Document Package Completed Date for the Study.
AD09-41	Study	[Planned Last Site Initiated Date]	The Planned Last Site Initiated Date for the Study.
AD09-44	Study	[Planned Last Subject 1st Visit Date]	The Planned Last Subject 1st Visit Date for the Study.
AD09-42	Study	[Planned Last Subject Enrolled Date]	The Planned Last Subject Enrolled Date for the Study.
AD09-43	Study	[Planned Last Subject Last Visit Date]	The Planned Last Subject Last Visit Date for the Study.
AD09-68	Study	[Planned Last Subject Randomized Date]	The Planned Last Subject Randomized Date for the Study.
AD09-18	Study	[Planned Protocol Approval Date]	The Planned Protocol Approval Date for the Study.
AD09-17	Study	Product	The Product specified for the study
AD09-03	Study	Program	Name of the Program that owns the Study
AD09-04	Study	Project	OC Project containing the Study
AD09-77	Study	RACT Completed Date	Date that the RACT was completed.
AD09-79	Study		Description of the RACT.
AD09-78	Study		Name of the RACT.
AD09-76	Study		Name of the Template that was used for this RACT.
AD09-85	Study		The reason a protocol/center was terminated. This field is mandatory if the protocol status is set to Terminated.
AD09-01	Study	Study	Unique identifier for the Study
AD09-15	Study	Study Action Link	Action Link for Siebel Clinical Studies. Can be used to link back to Study record in Siebel Clinical
AD09-16	Study	Study Manager	The name of the primary person responsible for the study.
AD09-75	Study	Study Objective	The objective of the study.
AD09-10	Study	Study Phase	Phase
AD09-02	Study	Study Short Title	A unique short title for the Study
AD09-05	Study	Study Sponsor	Name of the Sponsor company for which this study is being conducted
AD09-11	Study	Study Status	Protocol Status
AD09-12	Study	Study Title	Title
AD09-13	Study	Study Type	Type
AD09-29	Study	[Target 1st Site Initiated to 1st Subject Enrolled (# Days)]	The Target 1st Site Initiated to 1st Subject Enrolled (# Days) for the Study.
AD09-27	Study	[Target 1st Site Initiated to Last Site Initiated (# Days)]	The Target 1st Site Initiated to Last Site Initiated (# Days) for the Study.
AD09-28	Study	[Target 1st Subject 1st Visit to Last Subject 1st Visit (# Days)]	The Target 1st Subject 1st Visit to Last Subject 1st Visit (# Days) for the Study.
AD09-47	Study	[Target 1st Subject Enrolled to Last Subject Enrolled (# Days)]	The Target 1st Subject Enrolled to Last Subject Enrolled (# Days) for the Study.
AD09-70	Study	[Target Critical Document Package Complete to Site Initiated (# Days)]	The Target Critical Document Package Complete to Site Initiated (# Days) for the Study.
M-STD14	Study	[Target Last Subject Last Visit to Database Lock (# Days)]	The Target Last Subject Last Visit to Database Lock (# Days) for the Study.
AD09-86	Study	[Target Number of Completers]	Number of subjects targeted for completion of this study.
AD09-22	Study	[Target Protocol Approved to 1st Site Initiated (# Days)]	The Target Protocol Approved to 1st Site Initiated (# Days) for the Study.
AD09-23	Study	[Target Protocol Approved to 1st Subject Enrolled (# Days)]	The Target Protocol Approved to 1st Subject Enrolled (# Days) for the Study.
AD09-71	Study	[Target Protocol Approved to 1st Subject Randomized (# Days)]	The Target Protocol Approved to 1st Subject Randomized (# Days) for the Study.
AD09-72	Study	[Target Protocol Approved to 1st Subject Screened (# Days)]	The Target Protocol Approved to 1st Subject Screened (# Days) for the Study.
AD09-30	Study	[Target Site Visit Completed to Follow Up Item Completed (# Days)]	The Target Site Visit Completed to Follow Up Item Completed (# Days) for the Study.
AD09-31	Study	[Target Site Visit Completed to Visit Report Approved (# Days)]	The Target Site Visit Completed to Visit Report Approved (# Days) for the Study.
AD09-32	Study	[Target Site Visit Completed to Visit Report Completed (# Days)]	The Target Site Visit Completed to Visit Report Completed (# Days) for the Study.
AD09-34	Study	[Target Site Visit Start to Site Visit Completed (# Days)]	The Target Site Visit Start to Site Visit Completed (# Days) for the Study.
AD09-33	Study	[Target Visit Report Completed to Visit Report Approved (# Days)]	The Target Visit Report Completed to Visit Report Approved (# Days) for the Study.
AD09-74	Study	[Therapeutic Area]	The name of the Therapeutic Area.
-	Study Team Member	-	Study Team Member attributes
AD19-07	Study Team Member	Email	Team member email address.
AD19-06	Study Team Member	End Date	Study Team Member End Date field.
AD19-01	Study Team Member	First Name	Study Team Member First Name field.
AD19-03	Study Team Member	Full Name	Study Team Member Full Name field.
AD19-02	Study Team Member	Last Name	Study Team Member Last Name field.
AD19-04	Study Team Member	Role	Study Team Member Role field.
AD19-05	Study Team Member	Start Date	Study Team Member Start Date field.
AD19-09	Study Team Member	Team Member Active	If the team member's end date is null, indicate that the team member is active.
AD19-08	Study Team Member	Team Member Comment	Study Team Member Comment field.
-	Study-Region	-	-
AD17-04	Study-Region	Region Action Link	Action Link for Siebel Clinical Regions. Can be used to link back to Region record in Siebel Clinical
AD17-03	Study-Region	Region CRO	CRO for a Region
AD17-01	Study-Region	Region Name	Protocol Region
AD17-02	Study-Region	Region Status	Status of Region
AD17-46	Study-Region	[Clinical Study Report Date]	The Clinical Study Report Date for the Study.
AD17-47	Study-Region	[Protocol Approved Date]	The Protocol Approved Date for the Study.
AD17-22	Study-Region	[Planned LE 1st Critical Document Package Completed Date]	The latest estimate of the Planned 1st Critical Document Package Completed Date for the Study-Region.
AD17-23	Study-Region	[Planned LE 1st Initial IRB/EC Approval Date]	The latest estimate of the Planned 1st Initial IRB/EC Approval Date for the Study-Region.
AD17-24	Study-Region	[Planned LE 1st IRB/EC Submission Date]	The latest estimate of the Planned 1st IRB Submission Date for the Study-Region.
AD17-25	Study-Region	[Planned LE 1st Site Initiated Date]	The latest estimate of the Planned 1st Site Initiated Date for the Study-Region.
AD17-26	Study-Region	[Planned LE 1st Subject 1st Visit Date]	The latest estimate of the Planned 1st Subject 1st Visit Date for the Study-Region.
AD17-27	Study-Region	[Planned LE 1st Subject Enrolled Date]	The latest estimate of the Planned 1st Subject Enrolled Date for the Study-Region.
AD17-28	Study-Region	[Planned LE 1st Subject Randomized Date]	The latest estimate of the Planned 1st Subject Randomized Date for the Study-Region.
AD17-29	Study-Region	[Planned LE 1st Subject Screened Date]	The latest estimate of the Planned 1st Subject Screened Date for the Study-Region.
AD17-30	Study-Region	[Planned LE Last Critical Document Package Completed Date]	The latest estimate of the Planned Last Critical Document Package Completed Date for the Study-Region.
AD17-31	Study-Region	[Planned LE Last Site Initiated Date]	The latest estimate of the Planned Last Site Initiated Date for the Study-Region.
AD17-32	Study-Region	[Planned LE Last Subject 1st Visit Date]	The latest estimate of the Planned Last Subject 1st Visit Date for the Study-Region.
AD17-33	Study-Region	[Planned LE Last Subject Enrolled Date]	The latest estimate of the Planned Last Subject Enrolled Date for the Study-Region.
AD17-34	Study-Region	[Planned LE Last Subject Last Visit Date]	The latest estimate of the Planned Last Subject Last Visit Date for the Study-Region.
AD17-35	Study-Region	[Planned LE Last Subject Randomized Date]	The latest estimate of the Planned Last Subject Randomized Date for the Study-Region.
AD17-19	Study-Region	[Planned 1st Critical Document Package Completed Date]	The Planned 1st Critical Document Package Completed Date for the Study-Region.
AD17-09	Study-Region	[Planned 1st Initial IRB/EC Approval Date]	The Planned 1st Initial IRB/EC Approval Date for the Study-Region.
AD17-20	Study-Region	[Planned 1st IRB/EC Submission Date]	The Planned 1st IRB Submission Date for the Study-Region.
AD17-05	Study-Region	[Planned 1st Site Initiated Date]	The Planned 1st Site Initiated Date for the Study-Region.
AD17-13	Study-Region	[Planned 1st Subject 1st Visit Date]	The Planned 1st Subject 1st Visit Date for the Study-Region.
AD17-10	Study-Region	[Planned 1st Subject Enrolled Date]	The Planned 1st Subject Enrolled Date for the Study-Region.
AD17-11	Study-Region	[Planned 1st Subject Randomized Date]	The Planned 1st Subject Randomized Date for the Study-Region.
AD17-12	Study-Region	[Planned 1st Subject Screened Date]	The Planned 1st Subject Screened Date for the Study-Region.
AD17-21	Study-Region	[Planned Last Critical Document Package Completed Date]	The Planned Last Critical Document Package Completed Date for the Study-Region.
AD17-07	Study-Region	[Planned Last Site Initiated Date]	The Planned Last Site Initiated Date for the Study-Region.
AD17-15	Study-Region	[Planned Last Subject 1st Visit Date]	The Planned Last Subject 1st Visit Date for the Study-Region.
AD17-14	Study-Region	[Planned Last Subject Enrolled Date]	The Planned Last Subject Enrolled Date for the Study-Region.
AD17-16	Study-Region	[Planned Last Subject Last Visit Date]	The Planned Last Subject Last Visit Date for the Study-Region.
AD17-36	Study-Region	[Planned Last Subject Randomized Date]	The Planned Last Subject Randomized Date for the Study-Region.
AD17-06	Study-Region	[Expected % Sites Recruiting 0 Subjects]	The Expected % Sites Recruiting 0 Subjects for the Study-Region.
AD17-42	Study-Region	[Expected Early Termination Rate]	The expected early termination rate for the Study-Region.
AD17-37	Study-Region	[Expected Retention Rate]	The Expected Retention Rate for the Study-Region.
AD17-38	Study-Region	[Expected Screen Failure Rate]	The Expected Screen Failure Rate for the Study-Region.
AD17-39	Study-Region	[Target 1st Site Initiated to 1st Subject Enrolled (# Days)]	The Target 1st Site Initiated to 1st Subject Enrolled (# Days) for the Study-Region.
AD17-08	Study-Region	[Target 1st Site Initiated to Last Site Initiated (# Days)]	The Target 1st Site Initiated to Last Site Initiated (# Days) for the Study-Region.
AD17-40	Study-Region	[Target 1st Subject 1st Visit to Last Subject 1st Visit (# Days)]	The Target 1st Subject 1st Visit to Last Subject 1st Visit (# Days) for the Study-Region.
AD17-18	Study-Region	[Target 1st Subject Enrolled to Last Subject Enrolled (# Days)]	The Target 1st Subject Enrolled to Last Subject Enrolled (# Days) for the Study-Region.
AD17-41	Study-Region	[Target Critical Document Package Complete to Site Initiated (# Days)]	The Target Critical Document Package Complete to Site Initiated (# Days) for the Study-Region.
AD17-49	Study-Region	RACT Completed Date	Date that the RACT was completed.
AD17-51	Study-Region	RACT Description	Description of the RACT.
AD17-50	Study-Region	RACT Name	Name of the RACT.
AD17-48	Study-Region	RACT Template Name	Name of the Template that was used for this RACT.
AD17-43	Study-Region	Region Name	The Region name.
AD17-17	Study-Region	Study-Region Manager	The manager for the Study-Region.
AD17-44	Study-Region	Study-Region Name	The name of the Study-Region
AD17-45	Study-Region	[Therapeutic Area]	The name of the Therapeutic Area.
-	Study-Region Team Member	-	-
AD21-07	Study-Region Team Member	Email	Team member email address.
AD21-06	Study-Region Team Member	End Date	Study-Region Team Member End Date field.
AD21-01	Study-Region Team Member	First Name	Study-Region Team Member First Name field.
AD21-03	Study-Region Team Member	Full Name	Study-Region Team Member Full Name field.
AD21-02	Study-Region Team Member	Last Name	Study-Region Team Member Last Name field.
AD21-04	Study-Region Team Member	Role	Study-Region Team Member Role field.
AD21-05	Study-Region Team Member	Start Date	Study-Region Team Member Start Date field.
AD21-09	Study-Region Team Member	Team Member Active	If the team member's end date is null, indicate that the team member is active.
AD21-08	Study-Region Team Member	Team Member Comment	Study-Region Team Member Comment field.
AD8	Study-Site	-	A physical setting at which one or more studies are conducted.
AD10-10	Study-Site	1st Subject Enrolled Date	Date on which first subject was enrolled at the study-site.
AD10-32	Study-Site	City	Site City
AD10-44	Study-Site	Country	Site Country
AD10-31	Study-Site	County	Site County
AD10-42	Study-Site	CRA	The name of the primary person responsible for the study-site.
AD10-24	Study-Site	CRO	CRO conducting the study at this site
AD10-25	Study-Site	Data Capture Mode	The mode of doing data entry at this study-site. Possible values are {'EDC' | 'Paper' | 'Paper and EDC' | 'Unknown'}
TA-SITE01	Study-Site	Initial IRB/EC Approval Date	Earliest IRB Approval date for a Site
AD10-08	Study-Site	Planned Enrollment Completion Date	Date on which enrollment is (or was) planned to be complete
AD10-07	Study-Site	Planned Enrollment Start Date	Date on which enrollment is (or was) expected to start. This is the date at which subjects start being sought, not the date of the enrollment of the first subject.
AD10-33	Study-Site	Postal Code	Site Postal Code
AD10-22	Study-Site	Principal Investigator	Full name of Investigator currently responsible for the study at the site
AD10-43	Study-Site	Product	The Product specified for the study
AD10-05	Study-Site	Program	Name of the OC Program that owns the Study
AD10-06	Study-Site	Project	Name of the Project that owns the Study
AD10-51	Study-Site	[Critical Document Package Completed Date]	The Critical Document Package Completed Date for the Study-Site.
AD10-56	Study-Site	[Initial IRB/EC Submission Date]	The Initial IRB Submission Date for the Study-Site.
AD10-74	Study-Site	Site Terminated Date	The Site Terminated Date for the Study-Site.
AD10-58	Study-Site	[Planned LE 1st Subject 1st Visit Date]	The latest estimate of the Planned 1st Subject 1st Visit Date for the Study-Site.
AD10-59	Study-Site	[Planned LE 1st Subject Enrolled Date]	The latest estimate of the Planned 1st Subject Enrolled Date for the Study-Site.
AD10-60	Study-Site	[Planned LE 1st Subject Randomized Date]	The latest estimate of the Planned 1st Subject Randomized Date for the Study-Site.
AD10-61	Study-Site	[Planned LE 1st Subject Screened Date]	The latest estimate of the Planned 1st Subject Screened Date for the Study-Site.
AD10-62	Study-Site	[Planned LE Critical Document Package Completed Date]	The latest estimate of the Planned Critical Document Package Completed Date for the Study-Site.
AD10-63	Study-Site	[Planned LE Initial IRB/EC Approval Date]	The latest estimate of the Planned Initial IRB/EC Approval Date for the Study-Site.
AD10-64	Study-Site	[Planned LE IRB/EC Submission Date]	The latest estimate of the Planned IRB Submission Date for the Study-Site.
AD10-65	Study-Site	[Planned LE Last Subject 1st Visit Date]	The latest estimate of the Planned Last Subject 1st Visit Date for the Study-Site.
AD10-66	Study-Site	[Planned LE Last Subject Enrolled Date]	The latest estimate of the Planned Last Subject Enrolled Date for the Study-Site.
AD10-67	Study-Site	[Planned LE Last Subject Last Visit Date]	The latest estimate of the Planned Last Subject Last Visit Date for the Study-Site.
AD10-68	Study-Site	[Planned LE Last Subject Randomized Date]	The latest estimate of the Planned Last Subject Randomized Date for the Study-Site.
AD10-69	Study-Site	[Planned LE Site Initiated Date]	The latest estimate of the Planned Site Initiated Date for the Study-Site.
AD10-73	Study-Site	[Planned 1st Subject 1st Visit Date]	The Planned 1st Subject 1st Visit Date for the Study-Site.
AD10-47	Study-Site	[Planned 1st Subject Enrolled Date]	The Planned 1st Subject Enrolled Date for the Study-Site.
AD10-53	Study-Site	[Planned 1st Subject Randomized Date]	The Planned 1st Subject Randomized Date for the Study-Site.
AD10-52	Study-Site	[Planned 1st Subject Screened Date]	The Planned 1st Subject Screened Date for the Study-Site.
AD10-55	Study-Site	[Planned Critical Document Package Completed Date]	The Planned Critical Document Package Completed Date for the Study-Site.
AD10-50	Study-Site	[Planned Initial IRB/EC Approval Date]	The Planned Initial IRB/EC Approval Date for the Study-Site.
AD10-57	Study-Site	[Planned IRB/EC Submission Date]	The Planned IRB Submission Date for the Study-Site.
AD10-46	Study-Site	[Planned Last Subject 1st Visit Date]	The Planned Last Subject 1st Visit Date for the Study-Site.
AD10-54	Study-Site	[Planned Last Subject Enrolled Date]	The Planned Last Subject Enrolled Date for the Study-Site.
AD10-48	Study-Site	[Planned Last Subject Last Visit Date]	The Planned Last Subject Last Visit Date for the Study-Site.
AD10-70	Study-Site	[Planned Last Subject Randomized Date]	The Planned Last Subject Randomized Date for the Study-Site.
AD10-49	Study-Site	[Planned Site Initiated Date]	The Planned Site Initiated Date for the Study-Site.
AD10-72	Study-Site	[Expected Early Termination Rate]	The expected early termination rate for the Study-Site.
AD10-71	Study-Site	[Expected Retention Rate]	The expected retention rate for the Study-Site.
AD10-76	Study-Site	Latitude	The latitude of the address for the Study-Site.
AD10-77	Study-Site	Longitude	The longitude of the address for the Study-Site
AD10-78	Study-Site	Max Enrollment	The maximum number of subjects that can be enrolled at the study-site.
AD10-79	Study-Site	RACT Template Name	Name of the Template that was used for this RACT.
AD10-80	Study-Site	RACT Completed Date	Date that the RACT was completed.
AD10-81	Study-Site	RACT Name	Name of the RACT.
AD10-82	Study-Site	RACT Description	Description of the RACT.
AD10-75	Study-Site	[Therapeutic Area]	The name of the Therapeutic Area.
AD10-41	Study-Site	Site Initiated Date	Site initiation date.
AD10-01	Study-Site	Site Name	Name of the Site being used for this Study Site.
AD10-45	Study-Site	State	Site State
AD10-34	Study-Site	Street Address	Study-Site address line 1
AD10-35	Study-Site	Street Address 2	Study-Site address line 2
AD10-36	Study-Site	Street Address 3	Study-Site address line 3
AD10-04	Study-Site	Study	Unique identifier for the Study
AD10-03	Study-Site	Study Region	Name of the study-specific region in which the study site is located
AD10-38	Study-Site	Study Region Status	Status of the Study Region (denormalized from Study.Region Status)
AD10-26	Study-Site	Study Sponsor	Sponsor of the research being done at the study-site. This is meaningful only if the user is a CRO. Will be defaulted with a value of "Not Specified"
AD10-40	Study-Site	Study Status	Status of the Study (denormalized from Study.Status)
AD10-37	Study-Site	Study, Site, and Investigator	In Business Model only - concatenation of Study #, Site #, P Investigator Last Name
AD10-39	Study-Site	Study-Site Action Link	Action Link for Siebel Clinical Site. Can be used to link back to Site record in Siebel Clinical
AD10-02	Study-Site	Study-Site ID #	Unique name given the site in the context of the Study.
AD10-29	Study-Site	Study-Site Status	Site Status
AD15	Study-Site Contacts	-	Study-Site Contact attributes
AD15-01	Study-Site Contacts	City	Study-Site contact city
AD15-19	Study-Site Contacts	Contact Action Link	Action Link for Siebel Clinical Contacts. Can be used to link back to Contact record in Siebel Clinical
AD15-02	Study-Site Contacts	Country	Study-Site contact country
AD15-03	Study-Site Contacts	County	Study-Site contact county
AD15-04	Study-Site Contacts	Email Address	Study-Site contact email address
AD15-05	Study-Site Contacts	Employee Flag	Study-Site Contact Employee Flag
AD15-06	Study-Site Contacts	Fax #	Study-Site contact fax number
AD15-07	Study-Site Contacts	First Name	Contact First Name
AD15-08	Study-Site Contacts	Full Name	Last name, then first name
AD15-09	Study-Site Contacts	Last Name	Contact Last Name
AD15-10	Study-Site Contacts	Middle Name	Contact Middle Name
AD15-11	Study-Site Contacts	Mobile #	Study-Site contact mobile number
AD15-12	Study-Site Contacts	Phone #	Study-Site contact phone number
AD15-13	Study-Site Contacts	Postal Code	Study-Site contact postal code
AD15-15	Study-Site Contacts	State	Study-Site contact state
AD15-16	Study-Site Contacts	Street Address	Study-Site contact street address
AD15-17	Study-Site Contacts	Street Address 2	Study-Site Contact Address Line 2
AD15-18	Study-Site Contacts	Street Address 3	Study-Site Contact Address Line 3
AD14	Study-Site Team Member	-	Study-Site Team Member attributes
AD14-10	Study-Site Team Member	Email	Team member Email address
AD14-06	Study-Site Team Member	End Date	End Date in the Team History view
AD14-01	Study-Site Team Member	First Name	Team member first name
AD14-03	Study-Site Team Member	Full Name	Last Name, First Name
AD14-02	Study-Site Team Member	Last Name	Team member last name
AD14-04	Study-Site Team Member	Role	Role in the Team History view
AD14-05	Study-Site Team Member	Start Date	Start Date in the Team History view
AD14-08	Study-Site Team Member	Team Member Action Link	Action Link for Siebel Clinical Employee. Can be used to link back to Employee record in Siebel Clinical
AD14-09	Study-Site Team Member	Team Member Active	Indicates that the team member does not have an end date and is still actively on the team
AD14-07	Study-Site Team Member	Team Member Comment	Comment in the Team History view
TD01	Subject	-	A person taking part in a study. While a person may participate in multiple studies, each participation corresponds to a unique subject
TD01-09	Subject	Birth Date	The subject's date of birth.
TD01-03	Subject	CRF Book	The ID of the DCI book to be used for this subject.
TD01-10	Subject	Death Date	The date that the subject was reported to have died.
TD01-18	Subject	Eligible Flag	Subject Eligible Flag
TD01-06	Subject	Enrollment Date	Date and time when this subject was enrolled in this study.
TD01-20	Subject	Enrollment ID	Enrollment ID
TD01-16	Subject	Gender	The subject's gender. Values are M for male and F for female.
TD01-07	Subject	Is Active	Is the subject one about whom CRFs are to be expected? This is to differentiate between two classes of people who may be given Subject IDs: (1) people who have not yet been screened or enrolled, and thus about whom no clinical trial data is to be expected, (2) people about who clinical trial data is to be expected. Setting for this will have to be user-dependent, since it hinges on when the user assigns a subject ID, and what that signifies with respect to expectation of clinical trial data. Defaults to 'Y'.
TD01-05	Subject	Is Early Terminated	A flag to show if the subject was terminated early from the study. VARCHAR2(1)
TD01-04	Subject	Is Hard Locked	A flag to show if the system prevents any changes to the data for this subject.
TD01-25	Subject	Protocol Deviation Flag	Subject Protocol Deviation Flag
TD01-22	Subject	Protocol Violation Flag	Subject Protocol Violation Flag
TD01-29	Subject	Randomization Date	Date on which the Subject was randomized
TD01-21	Subject	Randomization ID	Randomization ID
TD01-23	Subject	Screen Failure Reason	Screen Failure Reason
TD01-24	Subject	Screening #	Screening #
TD01-17	Subject	Screening Date	Date on which subject passed screening.
TD01-01	Subject	Study	Name of the clinical study in which this subject is a participant
TD01-30	Subject	Subject Action Link	Action Link for Siebel Clinical Subjects. Can be used to link back to Subject record in Siebel Clinical
TD01-27	Subject	Subject Age	Current date minus subject Birth Date
TD01-19	Subject	Subject Comments	Subject comment
TD01-28	Subject	Subject Current Status Date	Date of subject's current status
TD01-02	Subject	Subject ID	A unique code for the subject position within the clinical study.
TD01-08	Subject	Subject Initials	The subject's initials, in mixed case.
TD01-11	Subject	Subject Status	Subject's current status
TD01-12	Subject	Subject Termination Date	Date on which the Subject ended participation in the study.
TD01-26	Subject	Withdrawn Reason	Withdrawn reason
AD22-10	Therapeutic Area	[Expected % Sites Recruiting 0 Subjects]	The Expected % Sites Recruiting 0 Subjects for the Therapeutic Area.
AD22-11	Therapeutic Area	[Target Critical Document Package Complete to Site Initiated (# Days)]	The Target Critical Document Package Complete to Site Initiated (# Days) for the Therapeutic Area.
AD22-02	Therapeutic Area	[Target Last Subject Last Visit to Database Lock (# Days)]	The Target Last Subject Last Visit to Database Lock (# Days) for the Therapeutic Area.
AD22-03	Therapeutic Area	[Target Protocol Approved to 1st Site Initiated (# Days)]	The Target Protocol Approved to 1st Site Initiated (# Days) for the Therapeutic Area.
AD22-04	Therapeutic Area	[Target Protocol Approved to 1st Subject Enrolled (# Days)]	The Target Protocol Approved to 1st Subject Enrolled (# Days) for the Therapeutic Area.
AD22-12	Therapeutic Area	[Target Protocol Approved to 1st Subject Randomized (# Days)]	The Target Protocol Approved to 1st Subject Randomized (# Days) for the Therapeutic Area.
AD22-13	Therapeutic Area	[Target Protocol Approved to 1st Subject Screened (# Days)]	The Target Protocol Approved to 1st Subject Screened (# Days) for the Therapeutic Area.
AD22-05	Therapeutic Area	[Target Site Visit Completed to Follow Up Item Completed (# Days)]	The Target Site Visit Completed to Follow Up Item Completed (# Days) for the Therapeutic Area.
AD22-06	Therapeutic Area	[Target Site Visit Completed to Visit Report Approved (# Days)]	The Target Site Visit Completed to Visit Report Approved (# Days) for the Therapeutic Area.
AD22-07	Therapeutic Area	[Target Site Visit Completed to Visit Report Completed (# Days)]	The Target Site Visit Completed to Visit Report Completed (# Days) for the Therapeutic Area.
AD22-09	Therapeutic Area	[Target Site Visit Start to Site Visit Completed (# Days)]	The Target Site Visit Start to Site Visit Completed (# Days) for the Therapeutic Area.
AD22-08	Therapeutic Area	[Target Visit Report Completed to Visit Report Approved (# Days)]	The Target Visit Report Completed to Visit Report Approved (# Days) for the Therapeutic Area.
AD22-01	Therapeutic Area	[Therapeutic Area]	The name of the Therapeutic Area.
AD13	Validation Procedure	-	A specification of a rule that validates a particular aspect of collected data
AD13-01	Validation Procedure	Study	Study in which the Procedure is specified.
AD13-03	Validation Procedure	Validation Procedure Description	Description of the validation procedure
AD13-02	Validation Procedure	Validation Procedure Name	Name of the Validation Procedure
AD13-04	Validation Procedure	Validation Procedure Scope	Scope of data used in the Procedure: 1-EVENT 1-DCM 1-EVENT M-DCM M-EVENT 1-DCM M-EVENT M-DCM THES_DERIVATION

Facts in OHSCDA Presentation Catalog

Table B-2 describes the Facts displayed in the OHSCDA Presentation Catalog, and their Columns. For each Column, it shows the name of the Column, its description, and the Fact and Group within the Fact that contain the Column. The table is sorted by Group and Column, within Fact. This corresponds to how the Fact columns are organized in the Presentation Catalog, within the Fact folder. Each Fact Column has an ID number, which is provided for cross-reference to other tables in this Appendix.

Table B-2 Presentation Catalog - Facts

ID	Topic	Group	Column	Description
M-DSC03	Discrepancies	Counts	# Closed Discrepancies	Number of discrepancies that have either been obsolete or have been marked irresolvable.
M-DSC12	Discrepancies	Counts	# Days Current Discrepancies Open	For currently open discrepancies, number of days since creation
M-DSC11	Discrepancies	Counts	# Days Discrepancy Open	Days from creation of discrepancy to: - today, if discrepancy still open - date closed, if discrepancy closed.
M-DSC15	Discrepancies	Counts	# Days to Close Discrepancy	NULL if open; Days from creation of discrepancy to: date closed, if discrepancy closed
M-DSC09	Discrepancies	Counts	# Discrepancies Irresolvable	Number of discrepancies that have been marked irresolvable
M-DSC04	Discrepancies	Counts	# Discrepancies sent in DCFs	Number of discrepancies that have been included in one or more DCFs.
M-DSC02	Discrepancies	Counts	# Open Discrepancies	Number of discrepancies awaiting either being resolved or being marked irresolvable.
M-DSC01	Discrepancies	Counts	# Total Discrepancies	Number of discrepancies, both open and closed
TA-DISC09	Discrepancies	Transactional Data	Complete Visit Number	Planned event number || . || subevent number
TA-DISC13	Discrepancies	Transactional Data	CRF Book Page	Page within subject's CRF book where the question giving rise to the discrepancy is located
TA-DISC11	Discrepancies	Transactional Data	CRF Entry Date	Date on which the CRF containing the discrepant value was entered.
TA-DISC12	Discrepancies	Transactional Data	CRF Name	Name of the CRF (e.g. Demog) containing the discrepancy
TA-DISC14	Discrepancies	Transactional Data	CRF Page Section	Within the Page containing the discrepancy, the Section containing the discrepancy
TA-DISC15	Discrepancies	Transactional Data	CRF Question Group	Within the Page and Section, the Question Group containing the discrepancy
TA-DISC16	Discrepancies	Transactional Data	CRF Question Name	Within the Page and Section containing the discrepancy, the Question giving rise to the discrepancy
TA-DISC17	Discrepancies	Transactional Data	CRF Question Occurrence	For the Question giving rise to the discrepancy, the Occurrence Sequence Number of Question. Has value of zero if there is only one occurrence; has value in 1..n, where number of occurrences, n, is greater than zero.
TA-DISC21	Discrepancies	Transactional Data	Current Review Status	The current review status of the discrepancy. This tells where the discrepancy is in its movement through a processing workflow. The status values are initially defined by Oracle Clinical, with extensions allowed by customer.
TA-DISC26.1	Discrepancies	Transactional Data	Discrepancy Answered Date	Date when a query about the discrepancy was answered
TA-DISC26	Discrepancies	Transactional Data	Discrepancy Close Date	Date when the discrepancy was closed (i.e. closed, made obsolete, or marked irresolvable).
TA-DISC30	Discrepancies	Transactional Data	Discrepancy Comment Text	Text associated with the discrepancy
TA-DISC25	Discrepancies	Transactional Data	Discrepancy Creation Date	Date when the discrepancy was created
TA-DISC01	Discrepancies	Transactional Data	Discrepancy ID	Unique ID of the discrepancy
TA-DISC22.1	Discrepancies	Transactional Data	Discrepancy State	Open', 'Answered', 'Closed', possibly others.
TA-DISC22	Discrepancies	Transactional Data	Discrepancy Status	OC Discrepancy Status. Takes value of CURRENT, OBSOLETE
TA-DISC23	Discrepancies	Transactional Data	Discrepancy Type	How the discrepancy came into existence: Values are UNIVARIATE, MULTIVARIATE, MANUAL, and INDICATOR
TA-DISC04	Discrepancies	Transactional Data	Investigator	Study-Site Investigator
TA-DISC19	Discrepancies	Transactional Data	Is Irresolvable	True if the discrepancy review status has a long value of IRRESOLVABLE, which is OC's way of saying the review status is Irresolvable.
TA-DISC32	Discrepancies	Transactional Data	Origin	The origin of the discrepancy. Takes one of these values: {System; Non-system}
TA-DISC24	Discrepancies	Transactional Data	Resolution Type	How the discrepancy was resolved. NULL if not currently resolved. The possible values are initially defined by Oracle Clinical, with extensions allowed by customer.
TA-DISC31	Discrepancies	Transactional Data	Sent in DCF	Flag to indicate whether a discrepancy was sent in DCF
TA-DISC03	Discrepancies	Transactional Data	Site	Site at which the discrepancy was created
TA-DISC02	Discrepancies	Transactional Data	Study	Study in which the discrepancy was created
TA-DISC33	Discrepancies	Transactional Data	Study-Site	Name of the Study-Site at which the discrepancy was created
TA-DISC08	Discrepancies	Transactional Data	Sub-event Number	Sub-event number of the visit at which the value causing the discrepancy was collected
TA-DISC05	Discrepancies	Transactional Data	Subject ID	ID for the subject about whom the data were collected.
TA-DISC10	Discrepancies	Transactional Data	Subject Visit Date	Date of the subject visit when the value causing the discrepancy was collected
TA-DISC06	Discrepancies	Transactional Data	Subject Visit Name	Name of the subject visit at which the value causing the discrepancy was collected
TA-DISC07	Discrepancies	Transactional Data	Subject Visit Number	Number of the subject visit at which the value causing the discrepancy was collected
TA-DISC20	Discrepancies	Transactional Data	Validation Procedure Name	If the discrepancy arose from execution of a validation procedure, the name of that procedure. Null otherwise.
M-DRS02	Discrepancy Review Statuses	Transactional Data	# Days Discrepancy Ever in Review Status	Number of days a discrepancy ever occupied a particular discrepancy review status.
M-DRS03	Discrepancy Review Statuses	Statistics	Avg # Days Discrepancy Ever in Review Status	Number of days a discrepancy ever occupied a particular discrepancy review status, divided by the number of discrepancies ever in that review status
M-DRS04	Discrepancy Review Statuses	Statistics	Avg # Days Open Discrepancy Ever in Review Status	Number of days a currently open discrepancy ever occupied a discrepancy review status, divided by the number of discrepancies ever in that review status
M-DRS01	Discrepancy Review Statuses	Transactional Data	Discrepancy Review Status	A review status occupied by a discrepancy over the life of the discrepancy.
M-SST51	Document Metrics	Counts	# Days Document Outstanding	Number of days between Document Sent date and today's date, when Document Received date is null
M-SST50	Document Metrics	Counts	# Days from Document Sent to Document Received	Number of days between Document Sent date and Document Received Date
M-DOC02	Document Metrics	Intervals	# Days Until Document Expiration	The number of days between Document Expiration Date and today's date.
M-DOC01	Document Metrics	Counts	# Documents	Count of all Activities where Activity is Document or Site-Initiation
M-DOC03	Document Metrics	Counts	# Documents Outstanding	The number of documents with a Sent Date and no Received Date.
M-DOC04	Document Metrics	Counts	# Documents Received	The number of documents with a Received Date.
TA-DOC01	Document Metrics	Transactional Data	Activity	Document Activity
TA-DOC04	Document Metrics	Transactional Data	Activity Type	Activity Type
TA-DOC02	Document Metrics	Transactional Data	Document Comments	Document Comments
TA-DOC09	Document Metrics	Transactional Data	Document Domain	The domain of the document, such as study, region, study-site, contact, or account.
TA-DOC05	Document Metrics	Transactional Data	Document Expected Date	Document Expected Date
TA-DOC08	Document Metrics	Transactional Data	Document Expiration Date	Document Expiration Date
TA-DOC03	Document Metrics	Transactional Data	Document Name	Document Name
TA-DOC06	Document Metrics	Transactional Data	Document Received Date	Document Received Date
TA-DOC07	Document Metrics	Transactional Data	Document Sent Date	Document Sent Date
M-FUI02	Follow Up Item Metrics	Intervals	# Days Follow Up Item Open	If a Follow Up Item is resolved, the number of days between Site Visit Completed Date and Follow Up Item Completed Date. If the Follow Up Item is not resolved, the number of days between Site Visit Completed Date and today's date.
M-FUI03	Follow Up Item Metrics	Intervals	# Days Follow Up Item Outstanding	For outstanding Follow Up Items, the number of days between Parent Site Visit End and today's date.
M-FUI01	Follow Up Item Metrics	Intervals	# Days from Site Visit Completed to Follow Up Item Completed	The number of days between Site Visit Completed and Follow Up Item Resolved dates.
TA-FUI07	Follow Up Item Metrics	Transactional Data	Follow Up Item Action Link	Action Link for Siebel Clinical Follow Up Item. Can be used to link back to Follow Up Item record in Siebel Clinical
TA-FUI01	Follow Up Item Metrics	Transactional Data	Follow Up Item Comments	Follow Up Item Comments field
TA-FUI02	Follow Up Item Metrics	Transactional Data	Follow Up item Completed Date	Follow Up Item Resolved Date field
TA-FUI03	Follow Up Item Metrics	Transactional Data	Follow Up Item Created Date	Date Follow Up Item record was created
TA-FUI04	Follow Up Item Metrics	Transactional Data	Follow Up Item Description	Follow Up Item Description field
TA-FUI05	Follow Up Item Metrics	Transactional Data	Follow Up item Due Date	Follow Up Item Due Date field
TA-FUI06	Follow Up Item Metrics	Transactional Data	Follow Up Item Status	Follow Up Item Status field
TA-FUI07	Follow Up Item Metrics	Transactional Data	Follow Up Item Type	Follow Up Item Type field
M-ALL10	Overall Metrics	Counts	# Studies	The number of study records.
M-ALL09	Overall Metrics	Medians	[Median # Protocol Amendments per Study]	The median of the number of protocol amendments that occurred for all studies.
M-ALL20	Overall Metrics	Medians	[Median 1st Site Initiated to Last Site Initiated (# Days)]	The median of the following cycle time across all studies: 1st Site Initiated Date for Study to Last Site Initiated Date for Study.
M-ALL13	Overall Metrics	Medians	Median 1st Site Initiated to Latest Site Initiated (# Days)	The median of the following cycle time across all studies: 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study.
M-ALL14	Overall Metrics	Medians	[Median Critical Document Package Complete to Site Initiated (# Days)]	The median of the following cycle time across all Study-Sites: Critical Document Package Completed Date to Site Initiated Date.
M-ALL02	Overall Metrics	Medians	Median Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites: Initial IRB/EC Approval Date to 1st Subject 1st Visit Date.
M-ALL15	Overall Metrics	Medians	Median Initial IRB/EC Approval to Site Initiated (# Days)	The median of the following cycle time across all Study-Sites: Initial IRB/EC Approval Date to Site Initiated Date.
M-ALL21	Overall Metrics	Medians	[Median Last Subject Last Visit to Database Lock (# Days)]	The median of the following cycle time across all studies: Last Subject Last Visit Date for Study to Database Lock Date.
M-ALL03	Overall Metrics	Medians	[Median Protocol Approved to 1st Site Initiated (# Days)]	The median of the following cycle time across all studies: Protocol Approved Date to 1st Site Initiated Date for Study.
M-ALL04	Overall Metrics	Medians	[Median Protocol Approved to 1st Subject Enrolled (# Days)]	The median of the following cycle time across all studies: Protocol Approved Date to 1st Subject Enrolled Date for Study.
M-ALL05	Overall Metrics	Medians	[Median Protocol Approved to 1st Subject Randomized (# Days)]	The median of the following cycle time across all studies: Protocol Approved Date to 1st Subject Randomized Date for Study.
M-ALL06	Overall Metrics	Medians	[Median Protocol Approved to 1st Subject Screened (# Days)]	The median of the following cycle time across all studies: Protocol Approved Date to 1st Subject Screened Date for Study.
M-ALL07	Overall Metrics	Medians	Median Site Initiated to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites: Site Initiated for Study-Site to 1st Subject 1st Visit Date for Study-Site.
M-ALL16	Overall Metrics	Medians	Median Site Visit Completed to Follow Up Item Completed (# Days)	The median of the following cycle time across all completed site visits: Site Visit Completed Date to Follow Up Item Completed Date.
M-ALL17	Overall Metrics	Medians	Median Site Visit Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits: Site Visit Completed Date to Visit Report Approved Date.
M-ALL18	Overall Metrics	Medians	Median Site Visit Completed to Visit Report Completed (# Days)	The median of the following cycle time across all completed site visits: Site Visit Completed Date to Visit Report Completed Date.
M-ALL08	Overall Metrics	Medians	Median Site Visit Start to Site Visit Completed (# Days)	The median of the following cycle time across all completed site visits: Site Visit Start Date to Site Visit Completed Date.
M-ALL19	Overall Metrics	Medians	Median Visit Report Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits: Visit Report Completed Date to Visit Report Approved Date.
M-ALL01	Overall Metrics	Ratios	% Sites Recruiting 0 Subjects	The percentage of initiated sites that have not enrolled any subjects, across all studies.
M-ALL11	Overall Metrics	Ratios	% Sites Recruiting 1 or More Subjects	The percentage of Study-Sites that have at least one subject enrolled.
M-ALL12	Overall Metrics	Ratios	% Sites Recruiting at Least 90% of Planned Subjects	The percentage of Study-Sites that have enrolled 90% or more of their planned subjects.
M-PRG16	Program Metrics	Counts	# Studies	The number of study records.
M-PRG24	Program Metrics	Medians	Median # Days Between Site Visits	The median of the following cycle time across all site visits for a Program: number of days between consecutive Site Visit Start Dates for completed site visits.
M-PRG14	Program Metrics	Medians	[Median # Protocol Amendments per Study]	The median of the number of protocol amendments that occurred for all studies in a Program.
M-PRG22	Program Metrics	Medians	[Median 1st Site Initiated to Last Site Initiated (# Days)]	The median of the following cycle time across all studies in a Program: 1st Site Initiated Date for Study to Last Site Initiated Date for Study.
M-PRG01	Program Metrics	Medians	Median 1st Site Initiated to Latest Site Initiated (# Days)	The median of the following cycle time across all studies in a Program: 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study.
M-PRG19	Program Metrics	Medians	[Median Critical Document Package Complete to Site Initiated (# Days)]	The median of the following cycle time across all Study-Sites in a Program: Critical Document Package Completed Date to Site Initiated Date.
M-PRG03	Program Metrics	Medians	Median Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Program: Initial IRB/EC Approval Date to 1st Subject 1st Visit Date.
M-PRG04	Program Metrics	Medians	Median Initial IRB/EC Approval to Site Initiated (# Days)	The median of the following cycle time across all Study-Sites in a Program: Initial IRB/EC Approval Date to Site Initiated Date.
M-PRG23	Program Metrics	Medians	[Median Last Subject Last Visit to Database Lock (# Days)]	The median of the following cycle time across all studies in a Program: Last Subject Last Visit Date for Study to Database Lock Date.
M-PRG06	Program Metrics	Medians	[Median Protocol Approved to 1st Site Initiated (# Days)]	The median of the following cycle time across all studies in a Program: Protocol Approved Date to 1st Site Initiated Date for Study.
M-PRG07	Program Metrics	Medians	[Median Protocol Approved to 1st Subject Enrolled (# Days)]	The median of the following cycle time across all studies in a Program: Protocol Approved Date to 1st Subject Enrolled Date for Study.
M-PRG21	Program Metrics	Medians	[Median Protocol Approved to 1st Subject Randomized (# Days)]	The median of the following cycle time across all studies in a Program: Protocol Approved Date to 1st Subject Randomized Date for Study.
M-PRG20	Program Metrics	Medians	[Median Protocol Approved to 1st Subject Screened (# Days)]	The median of the following cycle time across all studies in a Program: Protocol Approved Date to 1st Subject Screened Date for Study.
M-PRG08	Program Metrics	Medians	Median Site Initiated to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Program: Site Initiated for Study-Site to 1st Subject 1st Visit Date for Study-Site.
M-PRG09	Program Metrics	Medians	Median Site Visit Completed to Follow Up Item Completed (# Days)	The median of the following cycle time across all completed site visits in a Program: Site Visit Completed Date to Follow Up Item Completed Date.
M-PRG10	Program Metrics	Medians	Median Site Visit Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits for a Program: Site Visit Completed Date to Visit Report Approved Date.
M-PRG11	Program Metrics	Medians	Median Site Visit Completed to Visit Report Completed (# Days)	The median of the following cycle time across all completed site visits for a Program: Site Visit Completed Date to Visit Report Completed Date.
M-PRG12	Program Metrics	Medians	Median Site Visit Start to Site Visit Completed (# Days)	The median of the following cycle time across all completed site visits for a Program: Site Visit Start Date to Site Visit Completed Date.
M-PRG13	Program Metrics	Medians	Median Visit Report Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits in a Program: Visit Report Completed Date to Visit Report Approved Date.
M-PRG15	Program Metrics	Ratios	% Sites Recruiting 0 Subjects	The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Program.
M-PRG17	Program Metrics	Ratios	% Sites Recruiting 1 or More Subjects	The percentage of Study-Sites that have at least one subject enrolled.
M-PRG18	Program Metrics	Ratios	% Sites Recruiting at Least 90% of Planned Subjects	The percentage of Study-Sites that have enrolled 90% or more of their planned subjects.
M-PRR12	Program RACT Metrics	-	Category Score	The risk score for the RACT Category. The score indicates the level of risk for the RACT Category.
M-PRR01	Program RACT Metrics	-	[Considerations]	Additional considerations for the question to aid in the discussion.
M-PRR02	Program RACT Metrics	-	[Detectability]	How easy is it to detect the risk? A higher detectability means a lower risk.
M-PRR03	Program RACT Metrics	-	[Functional Plan(s) Impacted]	The Functional Plan(s) that may be impacted if the RACT Question has a high risk score.
M-PRR04	Program RACT Metrics	-	Impact	What is the impact if a risk is realized? A lower impact means a lower risk.
M-PRR05	Program RACT Metrics	-	Mitigation / Comments	Any mitigations for the risk or any comments about the question.
M-PRR06	Program RACT Metrics	-	Number	The number of the question.
M-PRR07	Program RACT Metrics	-	[Probability]	The likelihood of a risk being realized. A lower probability means a lower risk.
M-PRR08	Program RACT Metrics	-	Question	Question for discussion that is being scored. Sometime called Attribute Name.
M-PRR09	Program RACT Metrics	-	[Rationale]	The rationale for the risk score.
M-PRR10	Program RACT Metrics	-	Risk Score	The risk score for this question, as calculated in the source system.
M-PRR11	Program RACT Metrics	-	Weight	The weight a score is given when calculating the total score for the Category.
M-PTL01	Protocol Version	-	Version	The version of the Protocol. This may be the original Protocol, or an amendment.
M-PTL02	Protocol Version	-	Approved Date	The date when the Protocol version was approved.
M-PTL03	Protocol Version	-	Original Version	Flag indicating if this version is the original or an amendment. Y indicates original and N indicates an amendment.
M-PTL04	Protocol Version	-	[Type]	Indicates the type of Protocol Amendment and may include such values as: Prime, Site, Region
M-PTL05	Protocol Version	-	[Amendment Avoidable]	Field used to signify if an amendment was avoidable or not
M-PTL06	Protocol Version	-	Comments	A brief description of the rationale for each change in the protocol.
M-RCF18	Received CRFs	Counts	# CRFs Awaiting Entry Completion	Count of CRFs that meet the criteria for Incomplete
M-RCF09	Received CRFs	Counts	# CRFs Blank	Count of Blank CRFs. This is the Total number of CRFs where a user has opened and marked the CRF as blank intentionally.
M-RCF19	Received CRFs	Counts	# CRFs Electronically Loaded	Number of CRFs that were electronically, i.e. batch, loaded
M-RCF01	Received CRFs	Counts	# CRFs Entry Complete	Total number of CRFs for which entry has been completed
M-RCF29.1	Received CRFs	Counts	# CRFs Hard Locked	Number of Hard Locked CRFs
M-RCF10	Received CRFs	Counts	# CRFs Present	Count of Present CRFs.
M-RCF29	Received CRFs	Counts	# CRFs Soft Locked	Number of Soft Locked CRFs
M-RCF37	Received CRFs	Intervals	# Days from CRF Entry Complete to Soft Locked	Interval between CRF Entry Complete and Soft Locked
M-RCF34	Received CRFs	Intervals	# Days from CRF Visit to Entry Complete	Interval between CRF visit date and (1) for eCRF: date on which first data entry completed; (2) for pCRF: date on which second data entry completed, if required for study, else first entry completed.
M-RCF35	Received CRFs	Intervals	# Days from eCRF Complete to Initial Verified	Interval between eCRF entry date and date of Initial Verification
M-RCF40	Received CRFs	Intervals	# Days from eCRF Complete to Soft Locked	# Days from date of eCRF Complete to Date when eCRF was Soft Locked.
M-RCF36	Received CRFs	Intervals	# Days from eCRF Entry Complete to Initially Approved	Number of days from eCRF entry completion to date when initially approved.
M-RCF38	Received CRFs	Intervals	# Days from eCRF Final Approval to Soft Locked	Number of days from most recent eCRF Approved to Soft Locked.
M-RCF30	Received CRFs	Intervals	# Days from eCRF Initially Verified to Finally Approved	For an eCRF currently both Verified and Approved, the interval, in days, between those initial verification and final approval, calculated as date(final approval) - date(initial verification)
M-RCF39	Received CRFs	Intervals	# Days from eCRF Visit to eCRF Complete	# Days from date of eCRF Visit to Date when entry complete
M-RCF76	Received CRFs	Intervals	# Days from pCRF Entry Complete to Soft Locked	Total # Days from pCRF Entry Complete to Soft Locked
M-RCF32	Received CRFs	Intervals	# Days from pCRF Pass 1 Entry to Pass 2 Entry Complete	Interval between pCRF first entry and second entry
M-RCF31.1	Received CRFs	Intervals	# Days from pCRF Visit to Entry Complete	Interval between pCRF visit date and completion of all required entry passes.
M-RCF31	Received CRFs	Intervals	# Days from pCRF Visit to Pass 1 Entry	Interval between pCRF visit date and date of first entry
M-RCF11	Received CRFs	Intervals	# Days pCRF Awaiting Pass 1 Entry	Number of days pCRF received in house, awaiting first entry, to today's date
M-RCF33	Received CRFs	Intervals	# Days pCRF Awaiting Pass 2 Entry from Pass 1 Entry	Number of days pCRF achieved first entry completion, to today's date, where pCRF status is still Pass 1 complete, and second pass is required
M-RCF24	Received CRFs	Counts	# eCRFs Approved	Number of eCRFs which have been approved by Investigator
M-RCF86	Received CRFs	Counts	# eCRFs Awaiting Entry Completion	Count of eCRFs that meet the criteria for Incomplete
M-RCF26	Received CRFs	Counts	# eCRFs Awaiting Re-Approval	Number of eCRFs requiring Re-Approval by Investigator
M-RCF22	Received CRFs	Counts	# eCRFs Awaiting Re-Verification	Number of eCRFs which require source-data Verification to be redone by the CRA/Monitor, after a change by the Investigator
M-RCF81	Received CRFs	Counts	# eCRFs Blank	Count of Blank eCRFs. This is the Total number of eCRFs where a user has opened and marked the eCRF as blank intentionally.
M-RCF68	Received CRFs	Counts	# eCRFs Entry Complete	Total number of eCRFs for which entry has been completed
M-RCF71.1	Received CRFs	Counts	# eCRFs Hard Locked	Total # of Hard Locked eCRFs
M-RCF70	Received CRFs	Counts	# eCRFs Initially Approved	Total number of eCRFs there were approved at least once
M-RCF69	Received CRFs	Counts	# eCRFs Initially Verified	Total number of eCRFs that were verified at least once
M-RCF25	Received CRFs	Counts	# eCRFs Not Approved	Number of eCRFs which require initial Approval by Investigator
M-RCF23	Received CRFs	Counts	# eCRFs Not Verified	Number of entry-complete eCRFs that have never been verified.
M-RCF75	Received CRFs	Counts	# eCRFs Present	Total # of Present # eCRFs
M-RCF72	Received CRFs	Counts	# eCRFs Soft Locked	Total number of Soft Locked eCRFs
M-RCF21.1	Received CRFs	Counts	# eCRFs To Be Approved	Number of eCRFs that either have never been approved or that are awaiting re-approval.
M-RCF21	Received CRFs	Counts	# eCRFs To be Verified	Number of eCRFs that either have never been verified or that are awaiting re-verification.
M-RCF84	Received CRFs	Counts	# eCRFs Unplanned	Number of eCRFs that are Present but collected at an unplanned event
M-RCF20	Received CRFs	Counts	# eCRFs Verified	Number of eCRFs which have been source-data verified by the CRA/Monitor
M-RCF15	Received CRFs	Counts	# pCRFs Awaiting Double Entry Reconciliation	Number of pCRFs awaiting double-entry reconciliation
M-RCF17	Received CRFs	Counts	# pCRFs Awaiting Entry Completion	Number of pCRFs awaiting completion of either first or second data entry
M-RCF08	Received CRFs	Counts	# pCRFs Awaiting Pass 1 Entry Completion	Number of pCRFs awaiting completion of first data entry, including those at Received status
M-RCF73	Received CRFs	Counts	# pCRFs Awaiting Pass 2 Entry	Total number of pCRFs Awaiting Pass 2 Entry
M-RCF16	Received CRFs	Counts	# pCRFs Awaiting Pass 2 Entry Completion	Number of pCRFs awaiting completion of second data entry
M-RCF82	Received CRFs	Counts	# pCRFs Blank	Count of Blank pCRFs. This is the Total number of pCRFs where a user has opened and marked the pCRF as blank intentionally.
M-RCF78	Received CRFs	Counts	# pCRFs Entry Complete	Total number of pCRFs for which entry has been completed
M-RCF74.1	Received CRFs	Counts	# pCRFs Hard Locked	Total # of Hard Locked pCRFs
M-RCF06	Received CRFs	Counts	# pCRFs Pass 1 Entry Started, but Incomplete	Number of pCRFs at Pass 1 Started
M-RCF07	Received CRFs	Counts	# pCRFs Pass 1 Entry Complete	Number of pCRFs at Pass 1 Complete
M-RCF14	Received CRFs	Counts	# pCRFs Pass 2 Entry Complete	Number of pCRFs completed second entry
M-RCF13	Received CRFs	Counts	# pCRFs Pass 2 Entry Started, but Incomplete	Number of pCRFs at Pass 2 Started or Pass 2 Pending
M-RCF83	Received CRFs	Counts	# pCRFs Present	Count of Present pCRFs
M-RCF05	Received CRFs	Counts	# pCRFs Received, Not Entered	Number of pCRFs at Received
M-RCF74	Received CRFs	Counts	# pCRFs Soft Locked	Total # of Soft Locked pCRFs
M-RCF85	Received CRFs	Counts	# pCRFs Unplanned	Number of pCRFs that are Present but collected at an unplanned event
M-RCF64.2	Received CRFs	Ratios	% CRFs Hard Locked / Entry Complete	100 * # CRFs Hard Locked/# CRFs Entry Complete
M-RCF62	Received CRFs	Ratios	% CRFs Soft Locked / Entry Complete	The ratio of CRFs Soft Locked to number of CRFs with Entry Complete, expressed as a percentage
M-RCF64.1	Received CRFs	Ratios	% CRFs Soft Locked / Present	% CRF Soft Locked/#CRFs Present
M-RCF55.1	Received CRFs	Ratios	% eCRFs Approved / Entry Complete	% #eCRFs Approved / # eCRFs Entry Complete
M-RCF52.1	Received CRFs	Ratios	% eCRFs Approved / Present	% # eCRFs Verified / # eCRFs Entry Complete
M-RCF64.3	Received CRFs	Ratios	% eCRFs Hard Locked / Entry Complete	100 * # eCRFs Hard Locked/# eCRFs Entry Complete
M-RCF62.1	Received CRFs	Ratios	% eCRFs Soft Locked / Entry Complete	The ratio of eCRFs Soft Locked to number of eCRFs with Entry Complete, expressed as a percentage
M-RCF58	Received CRFs	Ratios	% eCRFs Soft Locked / Present	% # eCRFs Soft Locked / # eCRFs Present
M-RCF55.2	Received CRFs	Ratios	% eCRFs Verified / Entry Complete	% #eCRFs Verified / # eCRFs Entry Complete
M-RCF52	Received CRFs	Ratios	% eCRFs Verified / Present	% # eCRFs Verified / # eCRFs Present
M-RCF64.4	Received CRFs	Ratios	% pCRFs Hard Locked / Entry Complete	100 * # pCRFs Hard Locked/# pCRFs Entry Complete
M-RCF62.2	Received CRFs	Ratios	% pCRFs Soft Locked / Entry Complete	The ratio of pCRFs Soft Locked to number of pCRFs with Entry Complete, expressed as a percentage
M-RCF65	Received CRFs	Ratios	% Processed / Present	% CRF completely entered / #CRFs Present
M-RCF64	Received CRFs	Ratios	% Re-Approval / Approved	The ratio of number of eCRFs requiring re-approval to the number currently approved expressed as a percentage.
M-RCF63	Received CRFs	Ratios	% Re-Verification / Verified	The ratio of number of eCRFs awaiting re-verification to the number currently verified, expressed as a percentage.
M-RCF49.2	Received CRFs	Statistics	Avg # Days from CRF Entry Complete to Soft Locked	For all Soft Locked CRFs, the average number of Days from date of CRF Complete to Date when CRF was Soft Locked.
M-RCF45	Received CRFs	Statistics	Avg # Days from CRF Visit to Entry Complete	Average interval between CRF visit date and (1) for eCRF: date on which first data entry completed; (2) for pCRF: date on which second data entry completed, if required for study, else first entry completed.
M-RCF46	Received CRFs	Statistics	Avg # Days from eCRF Complete to Initially Verified	Across all eCRFs that have every been set to Verified at the current level of analysis, the average number of days in the interval between eCRF entry date and date of Initial Verification
M-RCF49	Received CRFs	Statistics	Avg # Days from eCRF Complete to Soft Locked	For all Soft Locked eCRFs, the average number of Days from date of eCRF Complete to Date when eCRF was Soft Locked.
M-RCF47	Received CRFs	Statistics	Avg # Days from eCRF Entry Complete to Initially Approved	Across all eCRFs that have every been set to Approved at the current level of analysis, the average number of days in the interval between eCRF entry completion to date when initially approved.
M-RCF50	Received CRFs	Statistics	Avg # Days from eCRF Final Approval to Soft Locked	For all Soft Locked eCRFs, the average number of days from most recent eCRF Approved to Soft Locked.
M-RCF48	Received CRFs	Statistics	Avg # Days from eCRF Initially Verified to Finally Approved	For all eCRFs currently both Verified and Approved, the average interval between initial verification and final approval dates.
M-RCF41	Received CRFs	Statistics	Avg # Days from eCRF Visit to eCRF Complete	Across all eCRFs that are complete at the current level of analysis, the average number of days between the date of the visit when the CRF was collected and the date when it was Complete.
M-RCF49.1	Received CRFs	Statistics	Avg # Days from pCRF Entry Complete to Soft Locked	For all Soft Locked pCRFs, the average number of Days from date of pCRF Complete to Date when pCRF was Soft Locked.
M-RCF43	Received CRFs	Statistics	Avg # Days from pCRF First Entry to Second Entry Complete	Average interval between pCRF first entry and second entry
M-RCF45.1	Received CRFs	Statistics	Avg # Days from pCRF Visit to Entry Complete	Average interval between pCRF visit date and date on which second data entry completed, if required for study, else first entry completed.
M-RCF42	Received CRFs	Statistics	Avg # Days from pCRF Visit to First Entry	Average interval between pCRF visit date and date of first entry
M-RCF77	Received CRFs	Statistics	Avg # Days pCRF Awaiting Pass 1 Entry	Average # of Days pCRF Awaiting First Entry
M-RCF44	Received CRFs	Statistics	Avg # Days pCRF Awaiting Pass 2 Entry from Pass 1 Entry	Average number of days pCRF achieved first entry completion, to today's date, where pCRF status is still Pass 1 complete, and second pass is required
TA-RCRF09	Received CRFs	Transactional Data	Complete Visit Number	Planned event number || . || subevent number
TA-RCRF12	Received CRFs	Transactional Data	CRF Book Name	Name of the CRF Book used to organize collected pages
TA-RCRF11	Received CRFs	Transactional Data	CRF Name	Name of the CRF (e.g. Demog)
TA-RCRF35	Received CRFs	Transactional Data	Data Capture Mode	Mode in which this CRF was capture. Values = {Paper, EDC}
TA-RCRF01	Received CRFs	Transactional Data	Document ID	External identifier for the CRF
TA-RCRF14	Received CRFs	Transactional Data	Entry Date	Date on which the CRF was entered.
TA-RCRF34	Received CRFs	Transactional Data	Hard Lock Date	Date when last Hard Locked
TA-RCRF32	Received CRFs	Transactional Data	Initial Approval Date	Initial date on which the CRF was approved by the Investigator
TA-RCRF30	Received CRFs	Transactional Data	Initial Source Verification Date	Date on which the CRF was initially source-verified
TA-RCRF04	Received CRFs	Transactional Data	Investigator	Study-Site Investigator
TA-RCRF24	Received CRFs	Transactional Data	Is Awaiting First Entry completion	Flag indicating that a CRF is awaiting first entry completion
TA-RCRF20	Received CRFs	Transactional Data	Is Awaiting Re-Approval	Flag indicating whether a received CRF is awaiting re-approval
TA-RCRF17	Received CRFs	Transactional Data	Is Awaiting Re-Verification	Flag indicating whether a received CRF is awaiting re-verification
TA-RCRF25	Received CRFs	Transactional Data	Is Awaiting Second entry completion	Flag indicating that a CRF is awaiting second entry completion
TA-RCRF22	Received CRFs	Transactional Data	Is Blank	Flag indicating whether there is any data for this received DCI.
TA-RCRF26	Received CRFs	Transactional Data	Is Entry Complete	Flag indicating that a CRF is completely entered
TA-RCRF28	Received CRFs	Transactional Data	Is Hard Locked	If a Received CRF is Hard Locked, data in the cry is prevented from being modified. This can only be reversed by extraordinary means.
TA-RCRF19	Received CRFs	Transactional Data	Is not in Approved state	Flag indicating whether an eCRF has not yet ever been approved. "Y' means "not approved", else "N".
TA-RCRF16	Received CRFs	Transactional Data	Is not in Verified state	Flag indicating whether a an eCRF has not yet ever been verified. "Y' means "not verified, else "N".
TA-RCRF23	Received CRFs	Transactional Data	Is Soft Locked	If a Received CRF is Soft Locked, data in the cry is prevented from being modified. However, a soft-lock can be reversed, if it is necessary to modify data, without extraordinary measures.
TA-RCRF33	Received CRFs	Transactional Data	Most Recent Approval Date	Most recent date on which the CRF was approved by the Investigator
TA-RCRF31	Received CRFs	Transactional Data	Most Recent Source Verification Date	Most recent date on which the CRF was source-verified
TA-RCRF13	Received CRFs	Transactional Data	Page in CRF Book	Page number within subject's CRF book on which this CRF is located.
TA-RCRF15	Received CRFs	Transactional Data	Received CRF Status	Current status of the received CRF
TA-RCRF03	Received CRFs	Transactional Data	Site	Site at which the CRF was created
TA-RCRF29	Received CRFs	Transactional Data	Soft Lock Date	Date when last soft locked
TA-RCRF02	Received CRFs	Transactional Data	Study	Study in which the CRF was created
TA-RCRF08	Received CRFs	Transactional Data	Sub-event Number	Sub-event number of the visit at which the CRF was collected
TA-RCRF05	Received CRFs	Transactional Data	Subject ID	ID for the Subject about whom the data were collected.
TA-RCRF10	Received CRFs	Transactional Data	Subject Visit Date	Date of the subject visit when the CRF was collected
TA-RCRF06	Received CRFs	Transactional Data	Subject Visit Name	Name of the subject visit at which the CRF was collected
TA-RCRF07	Received CRFs	Transactional Data	Subject Visit Number	Number of the subject visit at which CRF was collected
M-REG14	Region Metrics	Counts	# Study-Regions	The number of Study-Region records.
M-REG16	Region Metrics	Medians	[Median Critical Document Package Complete to Site Initiated (# Days)]	The median of the following cycle time across all Study-Sites in a Region: Critical Document Package Completed Date to Site Initiated Date.
M-REG11	Region Metrics	Medians	Median Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Region: Initial IRB/EC Approval Date to 1st Subject 1st Visit Date.
M-REG12	Region Metrics	Medians	Median Initial IRB/EC Approval to Site Initiated (# Days)	The median of the following cycle time across all Study-Sites in a Region: Initial IRB/EC Approval Date to Site Initiated Date.
M-REG10	Region Metrics	Medians	Median Site Initiated to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Region: Site Initiated for Study-Site to 1st Subject 1st Visit Date for Study-Site.
M-REG15	Region Metrics	Medians	Median Site Initiated to 1st Subject Enrolled (# Days)	The median of the following cycle time across all Study-Sites in a Region: Site Initiated for Study-Site to 1st Subject Enrolled Date for Study-Site.
M-REG17	Region Metrics	Medians	Median Site Visit Completed to Follow Up Item Completed (# Days)	The median of the following cycle time across all completed site visits in a Region: Site Visit Completed Date to Follow Up Item Completed Date.
M-REG18	Region Metrics	Medians	Median Site Visit Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits for a Region: Site Visit Completed Date to Visit Report Approved Date.
M-REG19	Region Metrics	Medians	Median Site Visit Completed to Visit Report Completed (# Days)	The median of the following cycle time across all completed site visits for a Region: Site Visit Completed Date to Visit Report Completed Date.
M-REG20	Region Metrics	Medians	Median Visit Report Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits in a Region: Visit Report Completed Date to Visit Report Approved Date.
M-REG05	Region Metrics	Ratios	% Sites Recruiting 0 Subjects	The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Region.
M-REG07	Region Metrics	Ratios	% Sites Recruiting 1 or More Subjects	the number of sites recruiting one or more Subjects divided by the number of Sites Initiated.
M-REG09	Region Metrics	Ratios	% Sites Recruiting at Least 90% of Planned Subjects	the number of sites recruiting at least 90% of planned subjects divided by the number of Sites Initiated.
M-SIV01	Site Visit Metrics	Intervals	[# Days from Site Visit Completed to Visit Report Approved]	The number of days between Site Visit Completed and Visit Report Approved dates.
M-SIV02	Site Visit Metrics	Intervals	# Days from Site Visit Completed to Visit Report Completed	The number of days between Site Visit Completed and Visit Report Completed dates.
M-SIV03	Site Visit Metrics	Intervals	# Days from Site Visit Start to Site Visit Completed	Site Visit Completed Date - Site Visit Start Date
M-SIV04	Site Visit Metrics	Intervals	[# Days from Visit Report Completed to Visit Report Approved]	The number of days between Visit Report Completed and Visit Report Approved dates.
M-SIV05	Site Visit Metrics	Intervals	[# Days Visit Report Approval Outstanding]	For outstanding visit report approvals, the number of days between Site Visit report completion and today's date.
M-SIV06	Site Visit Metrics	Intervals	# Days Visit Report Completion Outstanding	For outstanding visit reports, the number of days between Site Visit End and today's date.
M-SIV07	Site Visit Metrics	Counts	# Follow Up Items	The number of Follow Up Item records.
M-SIV08	Site Visit Metrics	Counts	# Follow Up Items Completed	The number of follow up items with a Follow Up Item Completed Date.
M-SIV10	Site Visit Metrics	Counts	# Outstanding Follow Up Items	The number of unresolved Follow Up Items.
M-STD45	Study Metrics	Actual Milestones	[1st Critical Document Package Completed Date]	The earliest Critical Document Package Completed Date for all Study-Sites in the Study.
M-STD32	Study Metrics	Actual Milestones	1st Initial IRB/EC Approval Date	The first Initial IRB/EC Approval Date for all Study-Sites in the Study.
M-STD46	Study Metrics	Actual Milestones	[1st IRB/EC Submission Date]	The first IRB/EC Submission Date for all Study-Sites in the Study.
M-STD11	Study Metrics	Actual Milestones	1st Site Initiated Date	The earliest of site initiated dates for a study.
M-STD84	Study Metrics	Actual Milestones	1st Subject 1st Visit Date	The date of the first visit across all subjects for the Study.
M-STD85	Study Metrics	Actual Milestones	1st Subject Enrolled Date	First Subject Enrolled
M-STD86	Study Metrics	Actual Milestones	1st Subject Randomized Date	First Subject Randomized
M-STD87	Study Metrics	Actual Milestones	1st Subject Screened Date	First Subject Screened
M-STD57	Study Metrics	Actual Milestones	[Last Critical Document Package Completed Date]	The Last Critical Document Package Completed Date for the Study.
M-STD58	Study Metrics	Actual Milestones	[Last Site Initiated Date]	The Last Site Initiated Date for the Study.
M-STD59	Study Metrics	Actual Milestones	[Last Subject 1st Visit Date]	The Last Subject 1st Visit Date for the Study.
M-STD70	Study Metrics	Actual Milestones	[Last Subject Enrolled Date]	The Last Subject Enrolled Date for the Study.
M-STD68	Study Metrics	Actual Milestones	[Last Subject Last Visit Date]	The Last Subject Last Visit Date for the Study.
M-STD69	Study Metrics	Actual Milestones	[Last Subject Randomized Date]	The Last Subject Randomized Date for the Study.
M-STD47	Study Metrics	Actual Milestones	[Latest Critical Document Package Completed Date]	The Latest Critical Document Package Completed Date for the Study.
M-STD12	Study Metrics	Actual Milestones	Latest Site Initiated Date	The date of the most recent site initiated
M-STD88	Study Metrics	Actual Milestones	Latest Subject 1st Visit Date	The Latest 1st Visit Date across all subjects for the Study.
M-STD89	Study Metrics	Actual Milestones	Latest Subject Enrolled Date	Most recent date on which a subject enrolled in the study
M-STD90	Study Metrics	Actual Milestones	Latest Subject Latest Visit Date	The Latest Visit Date across all subjects for the Study.
M-STD91	Study Metrics	Actual Milestones	Latest Subject Randomized Date	Most recent date on which a subject was randomized
M-STD92	Study Metrics	Actual Milestones	Latest Subject Screened Date	Most recent date on which a subject was screened.
M-STD93	Study Metrics	Actual Milestones	[Study Design Blinding]	The type of blinding excluding washouts and run-ins.
M-STD16	Study Metrics	Counts	[# Protocol Amendments]	The number of amendments to the protocol.
M-STD114	Study Metrics	Counts	[# Protocol Amendments Avoidable]	The number of amendments to the protocol that were avoidable.
M-STD40	Study Metrics	Counts	# Sites Recruiting 0 Subjects	The number of initiated Study-Sites with 0 subjects enrolled.
M-STD42	Study Metrics	Counts	# Sites Recruiting at Least 90% of Planned Subjects	The number of initiated Study-Sites that have enrolled at least 90% of their planned subjects.
M-SST49	Study Metrics	Counts	# Sites with 1 or More Subjects Screened	Number of study-sites with 1 or more subjects screened
M-STD48	Study Metrics	Counts	# Study-Regions	The number of Study-Region records.
M-STD07	Study Metrics	Counts	# Study-Sites	# of protocol sites created for the study
M-STD13	Study Metrics	Counts	# Study-Sites Initiated	The number of initiated Study-Sites.
M-STD01	Study Metrics	Counts	# Study-Sites Planned for Study	Number of sites planned to execute the study
M-STD08	Study Metrics	Counts	# Study-Sites with 1 or more Subjects Enrolled	Number of sites with a value in the first subject enrolled date
M-STD02	Study Metrics	Counts	# Subjects Planned for Study	Total number of subjects planned to be enrolled for the Study
M-STD55	Study Metrics	Cycle Times	[1st Critical Document Package Complete to 1st Site Initiated (# Days)]	The number of days between 1st Critical Document Package Completed Date for the Study and 1st Site Initiated Date for the Study.
M-STD56	Study Metrics	Cycle Times	1st Initial IRB/EC Approval to 1st Site Initiated (# Days)	The number of days between 1st Initial IRB/EC Approval Date for the Study to 1st Site Initiated Date for the Study.
M-STD27	Study Metrics	Cycle Times	1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The number of days between 1st Initial IRB/EC Approval Date for the Study to 1st Subject 1st Visit Date for the Study.
M-STD24	Study Metrics	Cycle Times	1st Site Initiated to 1st Subject Enrolled (# Days)	The number of days between 1st Site Initated Date for a Study and 1st Subject Enrolled Date for a Study.
M-STD65	Study Metrics	Cycle Times	[1st Site Initiated to Last Site Initiated (# Days)]	The number of days from 1st Site Initiated Date for a Study to Last Site Initiated Date for a Study.
M-STD25	Study Metrics	Cycle Times	1st Site Initiated to Latest Site Initiated (# Days)	The number of days from 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study.
M-STD66	Study Metrics	Cycle Times	[1st Subject 1st Visit to Last Subject 1st Visit (# Days)]	The number of days from 1st Subject 1st Visit Date for a Study to Last Subject 1st Visit Date for a Study.
M-STD26	Study Metrics	Cycle Times	1st Subject 1st Visit to Latest Subject 1st Visit (# Days)	The number of days from 1st Subject 1st Visit Date for a Study to Latest Subject 1st Visit Date for a Study.
M-STD64	Study Metrics	Cycle Times	[1st Subject Enrolled to Last Subject Enrolled (# Days)]	The number of days from 1st Subject Enrolled Date for a Study and Last Subject Enrolled Date for a Study.
M-STD61	Study Metrics	Cycle Times	1st Subject Enrolled to Latest Subject Enrolled (# Days)	The number of days from 1st Subject Enrolled Date for a Study and Latest Subject Enrolled Date for a Study.
M-STD67	Study Metrics	Cycle Times	[Last Subject Last Visit to Database Lock (# Days)]	The number of days from Last Subject Last Visit Date for a Study to Database Lock Date for a Study.
M-STD15	Study Metrics	Cycle Times	Latest Subject Latest Visit to Database Lock (# Days)	The number of days from Latest Subject Latest Visit Date for a Study to Database Lock Date for a Study.
M-STD17	Study Metrics	Cycle Times	[Protocol Approved to 1st Site Initiated (# Days)]	The number of days from Protocol Approved Date for a Study to 1st Site Initiated Date for a Study.
M-STD18	Study Metrics	Cycle Times	[Protocol Approved to 1st Subject Enrolled (# Days)]	The number of days from Protocol Approved Date for a Study to 1st Subject Enrolled Date for a Study.
M-STD62	Study Metrics	Cycle Times	[Protocol Approved to 1st Subject Randomized (# Days)]	The number of days from Protocol Approved Date for a Study to 1st Subject Randomized Date for a Study.
M-STD44	Study Metrics	Cycle Times	[Protocol Approved to 1st Subject Screened (# Days)]	The number of days from Protocol Approved Date for a Study to 1st Subject Screened Date for a Study.
M-STD103	Study Metrics	Flags	[Anonymized Sample Collection]	Indicates that samples will be banked for genetic analyses after removing the subject's personal identifiers.
M-STD106	Study Metrics	Flags	[ClinTrials.Gov]	Indicates a protocol will be registered on Clinictrials.gov.
M-STD101	Study Metrics	Flags	[Compassionate Use]	Denotes a study in which the drug administered is for compassionate use only.
M-STD107	Study Metrics	Flags	[Covered Under Financial Disclosure]	Indicates this study meets the definition of "Covered" within the guidelines of Financial Disclosure.
M-STD82	Study Metrics	Flags	KPI Detail Reason	Detail reason for the Study KPI Flag
M-STD80	Study Metrics	Flags	KPI Flag	KPI Flag for the Study.
M-STD81	Study Metrics	Flags	KPI High Level Reason	High level reason for the Study KPI Flag
M-STD105	Study Metrics	Flags	[Medical Imaging]	Indicates if medical Imaging required for an endpoint to determine efficacy and/or clinical outcome.
M-STD79	Study Metrics	Flags	Milestone Detail Reason	Detail reason for the Study Milestone Flag
M-STD77	Study Metrics	Flags	Milestone Flag	Milestone Flag for the Study.
M-STD78	Study Metrics	Flags	Milestone High Level Reason	High level reason for the Study Milestone Flag
M-STD104	Study Metrics	Flags	[Non-Anonymized Genotyping]	Denotes that samples are to be used for specific genetic analyses designated in the protocol.
M-STD108	Study Metrics	Flags	[On Hold]	Indicates all forward progress on study (that is, enrollment and/or dosing) has been suspended or delayed and the study has not been terminated.
M-STD97	Study Metrics	Flags	[Pediatric Study]	Indicates whether the proposed patient population is to include under 18 years of age.
M-STD102	Study Metrics	Flags	[Pharmacogenetics Included]	Indicates that the study will involve genetic analysis.
M-STD113	Study Metrics	Flags	[Post Marketing Surveillance (PMS)]	Post Marketing Surveillance (PMS): A post marketing, non interventional study that is part of a routine national authorization process, required by regulation, and does not meet the definition of PAES or the CT34-POL definition of PASS, such as the German Anwendungs-beobachtungen [AWB] studies, Japanese, Philippine, or Korean post marketing studies.
M-STD76	Study Metrics	Flags	Recruitment Detail Reason	Detail reason for the Study Recruitment Flag.
M-STD74	Study Metrics	Flags	Recruitment Flag	Recruitment Flag for the Study.
M-STD75	Study Metrics	Flags	Recruitment High Level Reason	High level reason for the Study Recruitment Flag
M-STD73	Study Metrics	Flags	Retention Detail Reason	Detail reason for the Study Retention Flag
M-STD71	Study Metrics	Flags	Retention Flag	Retention Flag for the Study.
M-STD72	Study Metrics	Flags	Retention High Level Reason	High level reason for the Study Retention Flag
M-STD110	Study Metrics	Flags	[Study Apply DO Resources]	Indicates resources are to be applied to the study as defined by the study's governing Business Unit.
M-STD49	Study Metrics	Medians	Median # Days Between Site Visits	The median of the following cycle time across all site visits for a Study: number of days between consecutive Site Visit Start Dates for completed site visits.
M-STD50	Study Metrics	Medians	Median # Follow Up Items per Site Visit	The median of the number of follow up items per site visit for all completed site visits that occurred for a Study.
M-STD51	Study Metrics	Medians	[Median Critical Document Package Complete to Site Initiated (# Days)]	The median of the following cycle time across all Study-Sites in a Study: Critical Document Package Completed Date to Site Initiated Date.
M-STD21	Study Metrics	Medians	Median Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Study: Initial IRB/EC Approval Date to 1st Subject 1st Visit Date.
M-STD22	Study Metrics	Medians	Median Initial IRB/EC Approval to Site Initiated (# Days)	The median of the following cycle time across all Study-Sites in a Study: Initial IRB/EC Approval Date to Site Initiated Date.
M-STD20	Study Metrics	Medians	Median Site Initiated to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Study: Site Initiated for Study-Site to 1st Subject 1st Visit Date for Study-Site.
M-STD60	Study Metrics	Medians	Median Site Initiated to 1st Subject Enrolled (# Days)	The median of the following cycle time across all Study-Sites in a Study: Site Initiated for Study-Site to 1st Subject Enrolled Date for Study-Site.
M-STD52	Study Metrics	Medians	Median Site Visit Completed to Follow Up Item Completed (# Days)	The median of the following cycle time across all completed site visits in a Study: Site Visit Completed Date to Follow Up Item Completed Date.
M-STD53	Study Metrics	Medians	Median Site Visit Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits for a Study: Site Visit Completed Date to Visit Report Approved Date.
M-STD54	Study Metrics	Medians	Median Site Visit Completed to Visit Report Completed (# Days)	The median of the following cycle time across all completed site visits for a Study: Site Visit Completed Date to Visit Report Completed Date.
M-STD09	Study Metrics	Medians	Median Site Visit Start to Site Visit Completed (# Days)	The median of the following cycle time across all completed site visits for a Study: Site Visit Start Date to Site Visit Completed Date.
M-STD63	Study Metrics	Medians	Median Visit Report Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits in a Study: Visit Report Completed Date to Visit Report Approved Date.
M-STD43	Study Metrics	Rates	# Subjects Enrolled per Month Study Active	For a Study that has not achieved database lock, the number of subjects enrolled per month since the first site was Initiated. For a Study that has achieved database lock, the number of subjects enrolled per month for the period between First Site Initiation and Latest Subject Enrolled at Study.
M-STD28	Study Metrics	Ratios	% of Planned Sites Initiated	The percentage of Study-Sites planned for the Study that have been initiated.
M-STD23	Study Metrics	Ratios	% Over/Under Enrolled	The percentage of planned subjects over (+) or under (-) enrolled for the Study.
M-STD06	Study Metrics	Ratios	% Planned Subjects Enrolled (Study)	Ratio of number of enrolled subjects to total planned number of subjects for the study
M-STD10	Study Metrics	Ratios	% Planned Subjects Randomized (Study)	The % of planned subjects randomized.
M-STD29	Study Metrics	Ratios	% Sites Recruiting 0 Subjects	The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Study.
M-STD30	Study Metrics	Ratios	% Sites Recruiting 1 or More Subjects	the number of sites recruiting one or more Subjects divided by the number of Sites Initiated.
M-STD31	Study Metrics	Ratios	% Sites Recruiting at Least 90% of Planned Subjects	the number of sites recruiting at least 90% of planned subjects divided by the number of Sites Initiated.
M-STD83	Study Metrics	Ratios	Screen Failure Rate	The number of subjects who failed screening divided by the number of subjects screened for the Study.
M-STD94	Study Metrics	­	[Gender of Subjects]	Gender of subjects who may be recruited into the study
M-STD99	Study Metrics	­	[Planned Duration Per Subject Unit]	Maximum period of time during which a typical subject is likely to be enrolled in the study. This includes the duration of drug treatment plus any screening (signed consent form), run-in, washout and follow-up periods.
M-STD96	Study Metrics	­	[Sponsoring Division]	This is the division that has overall responsibility for the conduction of the study.
M-STD95	Study Metrics	­	[Sponsoring Unit]	The subdivision/unit that has final reporting responsibility for the study.
M-STD98	Study Metrics	­	[Statistical Design]	Study design that later on helps to determine what type of reporting and statistical work needs to be done with the data.
M-STD112	Study Metrics	­	[Study Business Group]	This is used to differentiate Clinical Research (CROps) studies from Clinical Development studies.
M-STD111	Study Metrics	­	[Study Design]	The study design.
M-STD109	Study Metrics	­	[Study Project Plan Finance Type]	The project plan type.
M-STD100	Study Metrics	­	[Type of Subjects Recruited]	Defines the population of study subjects.
M-SDR12	Study RACT Metrics	­	Category Score	The risk score for the RACT Category. The score indicates the level of risk for the RACT Category.
M-SDR13	Study RACT Metrics	-	RACT Score	Total Risk score calculated from the RACT questions.
M-SDR01	Study RACT Metrics	­	[Considerations]	Additional considerations for the question to aid in the discussion.
M-SDR02	Study RACT Metrics	­	[Detectability]	How easy is it to detect the risk? A higher detectability means a lower risk.
M-SDR03	Study RACT Metrics	­	[Functional Plan(s) Impacted]	The Functional Plan(s) that may be impacted if the RACT Question has a high risk score.
M-SDR04	Study RACT Metrics	­	Impact	What is the impact if a risk is realized? A lower impact means a lower risk.
M-SDR05	Study RACT Metrics	­	Mitigation / Comments	Any mitigations for the risk or any comments about the question.
M-SDR06	Study RACT Metrics	­	Number	The number of the question.
M-SDR07	Study RACT Metrics	­	[Probability]	The likelihood of a risk being realized. A lower probability means a lower risk.
M-SDR08	Study RACT Metrics	­	Question	Question for discussion that is being scored. Sometime called Attribute Name.
M-SDR09	Study RACT Metrics	­	[Rationale]	The rationale for the risk score.
M-SDR10	Study RACT Metrics	­	Risk Score	The risk score for this question, as calculated in the source system.
M-SDR11	Study RACT Metrics	­	Weight	The weight a score is given when calculating the total score for the Category.
M-STR10	Study-Region Metrics	Actual Milestones	[1st Critical Document Package Completed Date]	The earliest Critical Document Package Completed Date for all Study-Sites in the Study-Region.
M-SRG07	Study-Region Metrics	Actual Milestones	1st Initial IRB/EC Approval Date	The first Initial IRB/EC Approval Date for all Study-Sites in the Study-Region.
M-SRG33	Study-Region Metrics	Actual Milestones	[1st IRB/EC Submission Date]	The first IRB/EC Submission Date for all Study-Sites in the Study-Region.
M-SRG03	Study-Region Metrics	Actual Milestones	1st Site Initiated Date	The first Site Initiated Date for all Study-Sites in the Study-Region.
M-STR31	Study-Region Metrics	Actual Milestones	1st Subject 1st Visit Date	The date of the first visit across all subjects for the Study-Region.
M-STR32	Study-Region Metrics	Actual Milestones	1st Subject Enrolled Date	First Subject Enrolled
M-STR33	Study-Region Metrics	Actual Milestones	1st Subject Randomized Date	First Subject Randomized
M-STR34	Study-Region Metrics	Actual Milestones	1st Subject Screened Date	First Subject Screened
M-STR03	Study-Region Metrics	Actual Milestones	Date Achieved 90% Planned Enrollment	The date on which the Study-Region achieved 90% of planned subject enrollment.
M-STR04	Study-Region Metrics	Actual Milestones	[Last Critical Document Package Completed Date]	The Last Critical Document Package Completed Date for the Study-Region.
M-STR05	Study-Region Metrics	Actual Milestones	[Last Site Initiated Date]	The Last Site Initiated Date for the Study-Region.
M-STR06	Study-Region Metrics	Actual Milestones	[Last Subject 1st Visit Date]	The Last Subject 1st Visit Date for the Study-Region.
M-STR20	Study-Region Metrics	Actual Milestones	[Last Subject Enrolled Date]	The Last Subject Enrolled Date for the Study-Region.
M-STR18	Study-Region Metrics	Actual Milestones	[Last Subject Last Visit Date]	The Last Subject Last Visit Date for the Study-Region.
M-STR19	Study-Region Metrics	Actual Milestones	[Last Subject Randomized Date]	The Last Subject Randomized Date for the Study-Region.
M-SRG34	Study-Region Metrics	Actual Milestones	[Latest Critical Document Package Completed Date]	The Latest Critical Document Package Completed Date for the Study-Region.
M-SRG35	Study-Region Metrics	Actual Milestones	Latest Subject Screened Date	Most recent date on which a subject was screened.
M-SRR12	Study-Region RACT Metrics	-	Category Score	The risk score for the RACT Category. The score indicates the level of risk for the RACT Category.
M-SRR13	Study-Region RACT Metrics	-	RACT Score	Total Risk score calculated from the RACT questions.
M-SRR13	Study-Site RACT Metrics	-	RACT Score	Total Risk score calculated from the RACT questions.
M-SRR01	Study-Region RACT Metrics	-	[Considerations]	Additional considerations for the question to aid in the discussion.
M-SRR02	Study-Region RACT Metrics	-	[Detectability]	How easy is it to detect the risk? A higher detectability means a lower risk.
M-SRR03	Study-Region RACT Metrics	-	[Functional Plan(s) Impacted]	The Functional Plan(s) that may be impacted if the RACT Question has a high risk score.
M-SRR04	Study-Region RACT Metrics	-	Impact	What is the impact if a risk is realized? A lower impact means a lower risk.
M-SRR05	Study-Region RACT Metrics	-	Mitigation / Comments	Any mitigations for the risk or any comments about the question.
M-SRR06	Study-Region RACT Metrics	-	Number	The number of the question.
M-SRR07	Study-Region RACT Metrics	-	[Probability]	The likelihood of a risk being realized. A lower probability means a lower risk.
M-SRR08	Study-Region RACT Metrics	-	Question	Question for discussion that is being scored. Sometime called Attribute Name.
M-SRR09	Study-Region RACT Metrics	-	[Rationale]	The rationale for the risk score.
M-SRR10	Study-Region RACT Metrics	-	Risk Score	The risk score for this question, as calculated in the source system.
M-SRR11	Study-Region RACT Metrics	-	Weight	The weight a score is given when calculating the total score for the Category.
M-SRG05	Study-Region Metrics	Actual Milestones	Latest Site Initiated Date	The Latest Site Initiated Date for the Study-Region.
M-STR35	Study-Region Metrics	Actual Milestones	Latest Subject 1st Visit Date	The Latest 1st Visit Date across all subjects for the Study-Region.
M-STR36	Study-Region Metrics	Actual Milestones	Latest Subject Enrolled Date	Most recent date on which a subject enrolled in the study
M-STR37	Study-Region Metrics	Actual Milestones	Latest Subject Latest Visit Date	The Latest Visit Date across all subjects for the Study-Region.
M-STR38	Study-Region Metrics	Actual Milestones	Latest Subject Randomized Date	Most recent date on which a subject was randomized
M-SRG27	Study-Region Metrics	Counts	# Sites Recruiting 0 Subjects	The number of initiated Study-Sites with 0 subjects enrolled.
M-SRG28	Study-Region Metrics	Counts	# Sites Recruiting 1 or More Subjects	The number of initiated Study-Sites with one or more subjects enrolled.
M-SRG29	Study-Region Metrics	Counts	# Sites Recruiting at Least 90% of Planned Subjects	The number of Study-Sites where the number of subjects enrolled divided by the number of subjects planned for the site is greater than or equal to 90%.
M-STR30	Study-Region Metrics	Counts	# Sites with 1 or More Subjects Screened	Number of study-sites with 1 or more subjects screened
M-SRG26	Study-Region Metrics	Counts	# Study-Sites	The number of Study-Site records.
M-SRG16	Study-Region Metrics	Counts	# Study-Sites Initiated	The number of initiated Study-Sites.
M-SRG01	Study-Region Metrics	Counts	# Study-Sites Planned for Study-Region	# Planned Sites for the study-region
M-SRG02	Study-Region Metrics	Counts	# Subjects Planned for Study-Region	# Planned Subjects for the study-region
M-STR09	Study-Region Metrics	Cycle Times	[1st Critical Document Package Complete to 1st Site Initiated (# Days)]	The number of days between 1st Critical Document Package Completed Date for the Study-Region and 1st Site Initiated Date for the Study-Region.
M-SRG14	Study-Region Metrics	Cycle Times	1st Initial IRB/EC Approval to 1st Site Initiated (# Days)	The number of days between 1st Initial IRB/EC Approval Date for a Study-Region to 1st Site Initiated Date for a Study-Region.
M-SRG13	Study-Region Metrics	Cycle Times	1st Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The number of days between 1st Initial IRB/EC Approval Date for a Study-Region and First Subject First Visit Date for a Study-Region.
M-SRG08	Study-Region Metrics	Cycle Times	1st Site Initiated to 1st Subject Enrolled (# Days)	The number of days between 1st Site Initated Date for a Study-Region and 1st Subject Enrolled Date for a Study-Region.
M-STR14	Study-Region Metrics	Cycle Times	[1st Site Initiated to Last Site Initiated (# Days)]	The number of days from 1st Site Initiated Date for a Study to Last Site Initiated Date for a Study-Region.
M-SRG06	Study-Region Metrics	Cycle Times	1st Site Initiated to Latest Site Initiated (# Days)	The number of days from 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study-Region.
M-STR15	Study-Region Metrics	Cycle Times	[1st Subject 1st Visit to Last Subject 1st Visit (# Days)]	The number of days from 1st Subject 1st Visit Date for a Study-Region to Last Subject 1st Visit Date for a Study-Region.
M-SRG12	Study-Region Metrics	Cycle Times	1st Subject 1st Visit to Latest Subject 1st Visit (# Days)	The number of days from 1st Subject 1st Visit Date for a Study-Region to Latest Subject 1st Visit Date for a Study-Region.
M-STR13	Study-Region Metrics	Cycle Times	[1st Subject Enrolled to Last Subject Enrolled (# Days)]	The number of days from 1st Subject Enrolled Date for a Study-Region to Last Subject Enrolled Date for a Study-Region.
M-STR02	Study-Region Metrics	Cycle Times	1st Subject Enrolled to Latest Subject Enrolled (# Days)	The number of days from 1st Subject Enrolled Date for a Study-Region to Latest Subject Enrolled Date for a Study-Region.
M-STR29	Study-Region Metrics	Flags	Milestone Detail Reason	Detail reason for the Study-Region Milestone Flag
M-STR27	Study-Region Metrics	Flags	Milestone Flag	Milestone Flag for the Study-Region.
M-STR28	Study-Region Metrics	Flags	Milestone High Level Reason	High level reason for the Study-Region Milestone Flag
M-STR26	Study-Region Metrics	Flags	Recruitment Detail Reason	Detail reason for the Study-Region Recruitment Flag
M-STR24	Study-Region Metrics	Flags	Recruitment Flag	Recruitment Flag for the Study-Region.
M-STR25	Study-Region Metrics	Flags	Recruitment High Level Reason	High level reason for the Study-Region Recruitment Flag
M-STR23	Study-Region Metrics	Flags	Retention Detail Reason	Detail reason for the Study-Region Retention Flag
M-STR21	Study-Region Metrics	Flags	Retention Flag	Retention Flag for the Study-Region.
M-STR22	Study-Region Metrics	Flags	Retention High Level Reason	High level reason for the Study-Region Retention Flag
M-STR11	Study-Region Metrics	Medians	Median # Days Between Site Visits	The median of the following cycle time across all site visits for a Study-Region: number of days between consecutive Site Visit Start Dates for completed site visits.
M-SRG09	Study-Region Metrics	Medians	Median # Follow Up Items per Site Visit	The median of the number of follow up items per site visit for all completed site visits that occurred for a Study-Region.
M-STR12	Study-Region Metrics	Medians	[Median Critical Document Package Complete to Site Initiated (# Days)]	The median of the following cycle time across all Study-Sites in a Study-Region: Critical Document Package Completed Date to Site Initiated Date.
M-SRG23	Study-Region Metrics	Medians	Median Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Study-Region: Initial IRB/EC Approval Date to 1st Subject 1st Visit Date.
M-SRG24	Study-Region Metrics	Medians	Median Initial IRB/EC Approval to Site Initiated (# Days)	The median of the following cycle time across all Study-Sites in a Study-Region: Initial IRB/EC Approval Date to Site Initiated Date.
M-SRG25	Study-Region Metrics	Medians	Median Site Initiated to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Study-Region: Site Initiated for Study-Site to 1st Subject 1st Visit Date for Study-Site.
M-STR08	Study-Region Metrics	Medians	Median Site Initiated to 1st Subject Enrolled (# Days)	The median of the following cycle time across all Study-Sites in a Study-Region: Site Initiated for Study-Site to 1st Subject Enrolled Date for Study-Site.
M-STR16	Study-Region Metrics	Medians	Median Site Visit Start to Site Visit Completed (# Days)	The median of the following cycle time across all completed site visits for a Region: Site Visit Start Date to Site Visit Completed Date.
M-SRG04	Study-Region Metrics	Ratios	% of Planned Sites Initiated	The percentage of Study-Sites planned for the Study-Region that have been initiated.
M-SRG11	Study-Region Metrics	Ratios	% Over/Under Enrolled	The percentage of planned subjects over (+) or under (-) enrolled for the Study-Region.
M-SRG10	Study-Region Metrics	Ratios	% Planned Subjects Randomized	The percentage of planned subjects randomized minus 100.
M-SRG30	Study-Region Metrics	Ratios	% Sites Recruiting 0 Subjects	The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Study-Region.
M-SRG31	Study-Region Metrics	Ratios	% Sites Recruiting 1 or More Subjects	the number of sites recruiting one or more Subjects divided by the number of Sites Initiated.
M-SRG32	Study-Region Metrics	Ratios	% Sites Recruiting at Least 90% of Planned Subjects	the number of sites recruiting at least 90% of planned subjects divided by the number of Sites Initiated.
M-STR07	Study-Region Metrics	Ratios	Screen Failure Rate	The number of subjects who failed screening divided by the number of subjects screened for the Study-Region.
M-SST96	Study-Site Metrics	Actual Milestones	1st Subject 1st Visit Date	The date of the first visit across all subjects for the Study-Site.
M-SST42	Study-Site Metrics	Actual Milestones	1st Subject Enrolled Date	First Subject Enrolled
M-SST43	Study-Site Metrics	Actual Milestones	1st Subject Randomized Date	First Subject Randomized
M-SST44	Study-Site Metrics	Actual Milestones	1st Subject Screened Date	First Subject Screened
M-SST88	Study-Site Metrics	Actual Milestones	Date Achieved 90% Planned Enrollment	The date on which the Study-Site achieved 90% of planned subject enrollment.
M-SST89	Study-Site Metrics	Actual Milestones	[Last Subject 1st Visit Date]	The Last Subject 1st Visit Date for the Study-Site.
M-SST90	Study-Site Metrics	Actual Milestones	[Last Subject Enrolled Date]	The Last Subject Enrolled Date for the Study-Site.
M-SST91	Study-Site Metrics	Actual Milestones	[Last Subject Last Visit Date]	The Last Subject Last Visit Date for the Study-Site.
M-SST92	Study-Site Metrics	Actual Milestones	[Last Subject Randomized Date]	The Last Subject Randomized Date for the Study-Site.
M-SST79	Study-Site Metrics	Actual Milestones	Latest Subject 1st Visit Date	The Latest 1st Visit Date across all subjects for the Study-Site.
M-SST46	Study-Site Metrics	Actual Milestones	Latest Subject Enrolled Date	Most recent date on which a subject enrolled in the study
M-SST81	Study-Site Metrics	Actual Milestones	Latest Subject Latest Visit Date	The Latest Visit Date across all subjects for the Study-Site.
M-SST47	Study-Site Metrics	Actual Milestones	Latest Subject Randomized Date	Most recent date on which a subject was randomized
M-SST48	Study-Site Metrics	Actual Milestones	Latest Subject Screened Date	Most recent date on which a subject was screened
M-SST61	Study-Site Metrics	Counts	# Completed Site Visits	The number of Site Visit records with a Site Visit Completed Date
M-SST62	Study-Site Metrics	Counts	# Completed Visit Reports	The number of Visit Reports where Completed Date is not null.
M-SST04	Study-Site Metrics	Counts	# Current Active Subjects	Total number of Subjects currently conducting Study
M-SST03	Study-Site Metrics	Counts	# Currently Enrolled plus # Normally Terminated	The total number of subjects who are either currently enrolled or who have normally completed the study protocol
M-SST39	Study-Site Metrics	Counts	# Days Since Initiation	Number of days from current date to Site Initiation Date
M-SST06	Study-Site Metrics	Counts	# Early Terminations	# Subjects who have ever had a status of Early Terminated
M-SST02	Study-Site Metrics	Counts	# Enrolled	# Subjects who have ever had a status of Enrolled For the value of # Enrolled measure to get populated from OC correctly, you must create a validation procedure to populate the Patient Statuses table for each study using two packaged procedures provided with Oracle Clinical. For information on how to create a validation procedure, see Oracle Clinical Creating a Study.
M-SST08	Study-Site Metrics	Counts	# Planned Subject Visits Completed	Number of planned Subject visits which have occurred. This is the count, across all CRFs received for all subjects at the site, of distinct planned visits at which the CRFs were collected. Planned visits are those for which sub-event number is zero.
M-SST32	Study-Site Metrics	Counts	# Randomized	# Subjects who have ever had a status of Randomized
M-SST33	Study-Site Metrics	Counts	# Re-Screened	# Subjects who have ever had a status of Re-screened
M-SST34	Study-Site Metrics	Counts	# Screen Failure	# Subjects who have ever had a status of Screen Failure
M-SST35	Study-Site Metrics	Counts	# Screened	# Subjects who have ever had a status of Screened
M-SST65	Study-Site Metrics	Counts	# Site Visits	The number of Site Visit records
M-SST36	Study-Site Metrics	Counts	# Subjects	Count of the number of subject records returned
M-SST05C	Study-Site Metrics	Counts	# Subjects - Current Status Completed	# Subjects with a current status of Completed
M-SST06C	Study-Site Metrics	Counts	# Subjects - Current Status Early Terminated	Number of Subjects whose current status is Early Terminated
M-SST02C	Study-Site Metrics	Counts	# Subjects - Current Status Enrolled	# Subjects with a current status of Enrolled
M-SST32C	Study-Site Metrics	Counts	# Subjects - Current Status Randomized	# Subjects with a current status of Randomized
M-SST33C	Study-Site Metrics	Counts	# Subjects - Current Status Re-Screened	# Subjects with a current status of Re-screened
M-SST34C	Study-Site Metrics	Counts	# Subjects - Current Status Screen Failure	# Subjects with a current status of Screen failure
M-SST35C	Study-Site Metrics	Counts	# Subjects - Current Status Screened	# Subjects with a current status of Screened
M-SST37	Study-Site Metrics	Counts	# Subjects Deviation	Number of subjects with the Protocol Deviation flag checked
M-SST66	Study-Site Metrics	Counts	# Subjects Enrolled Since Latest Site Visit	The number of subjects that have been enrolled since the most recent Site Visit End date.
M-SST01	Study-Site Metrics	Counts	# Subjects Planned for Study-Site	Total number of subjects planned to be enrolled at the Study-Site.
M-SST67	Study-Site Metrics	Counts	# Subjects Randomized Since Latest Site Visit	The number of subjects that have been randomized since the most recent Site Visit End date.
M-SST68	Study-Site Metrics	Counts	# Subjects Screened Since Latest Site Visit	The number of subjects that have been screened since the most recent Site Visit End date.
M-SST38	Study-Site Metrics	Counts	# Subjects Violation	Number of subjects with the Protocol Violation flag checked
M-SST05	Study-Site Metrics	Counts	# Subjects who have Completed Study	# Subjects who have ever had a status of Completed
M-SST09	Study-Site Metrics	Counts	# Unplanned Subject Visits Completed	Number of unplanned Subject visits which have occurred. This is the count, across all CRFs received for all subjects at the site, of distinct unplanned visits at which the CRFs were collected. Unplanned visits are those for which sub-event number is greater than zero.
M-SST69	Study-Site Metrics	Counts	# Visit Reports	The number of visit report records
M-SST70	Study-Site Metrics	Counts	[# Visit Reports Awaiting Approval]	The number of visit reports where Completed Date is not null and Approved Date is null
M-SST71	Study-Site Metrics	Counts	# Visit Reports Awaiting Completion	The number of visit reports with a site visit end date but no visit report completion date
M-SST95	Study-Site Metrics	Cycle Times	[1st Subject 1st Visit to Last Subject 1st Visit (# Days)]	The number of days from 1st Subject 1st Visit Date for a Study-Site to Last Subject 1st Visit Date for a Study-Site.
M-SST80	Study-Site Metrics	Cycle Times	1st Subject 1st Visit to Latest Subject 1st Visit (# Days)	The number of days from 1st Subject 1st Visit Date for a Study-Site to Latest Subject 1st Visit Date for a Study-Site.
M-SST85	Study-Site Metrics	Cycle Times	[Critical Document Package Complete to Site Initiated (# Days)]	The number of days from Critical Document Package Completed for a Study-Site to Site Initiated Date.
M-SST83	Study-Site Metrics	Cycle Times	Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The number of days from Initial IRB/EC Approval Date for a Study-Site and 1st Subject 1st Visit for a Study-Site.
M-SST84	Study-Site Metrics	Cycle Times	Initial IRB/EC Approval to Site Initiated (# Days)	The number of days from Initial IRB/EC Approval Date for a Study-Site and Site Initiated Date for a Study-Site.
M-SST82	Study-Site Metrics	Cycle Times	Site Initiated to 1st Subject 1st Visit (# Days)	The number of days from Site Initiated Date for a Study-Site to 1st Subject 1st Visit Date for a Study-Site.
M-SST93	Study-Site Metrics	Cycle Times	Site Initiated to 1st Subject Enrolled (# Days)	The number of days from Site Initiated Date for a Study-Site to 1st Subject Enrolled Date for a Study-Site.
M-SST105	Study-Site Metrics	Flags	Milestone Detail Reason	Detail reason for the Study-Site Milestone Flag
M-SST106	Study-Site Metrics	Counts	[# Times Study-Site Missed Dose]	The number of times a Study-Site missed a dose at Site due to lack of drug supply.
M-SST103	Study-Site Metrics	Flags	Milestone Flag	Milestone Flag for the Study-Site.
M-SST104	Study-Site Metrics	Flags	Milestone High Level Reason	High level reason for the Study-Site Milestone Flag
M-SST102	Study-Site Metrics	Flags	Recruitment Detail Reason	Detail reason for the Study-Site Recruitment Flag
M-SST100	Study-Site Metrics	Flags	Recruitment Flag	Recruitment Flag for the Study-Region.
M-SST101	Study-Site Metrics	Flags	Recruitment High Level Reason	High level reason for the Study-Site Recruitment Flag
M-SST99	Study-Site Metrics	Flags	Retention Detail Reason	Detail reason for the Study-Site Retention Flag
M-SMD01	Study-Site Missed Dose	-	[Date Dose Missed]	Date of Missed dose at Site due to lack of drug supply
M-SMD02	Study-Site Missed Dose	-	[Entry Date]	Date missed dose was entered into the system
M-SMD03	Study-Site Missed Dose	-	[Reason]	Reason for missed dosing
M-SSR12	Study-Site RACT Metrics	-	Category Score	The risk score for the RACT Category. The score indicates the level of risk for the RACT Category.
M-SSR01	Study-Site RACT Metrics	-	[Considerations]	Additional considerations for the question to aid in the discussion.
M-SSR02	Study-Site RACT Metrics	-	[Detectability]	How easy is it to detect the risk? A higher detectability means a lower risk.
M-SSR03	Study-Site RACT Metrics	-	[Functional Plan(s) Impacted]	The Functional Plan(s) that may be impacted if the RACT Question has a high risk score.
M-SSR04	Study-Site RACT Metrics	-	Impact	What is the impact if a risk is realized? A lower impact means a lower risk.
M-SSR05	Study-Site RACT Metrics	-	Mitigation / Comments	Any mitigations for the risk or any comments about the question.
M-SSR06	Study-Site RACT Metrics	-	Number	The number of the question.
M-SSR07	Study-Site RACT Metrics	-	[Probability]	The likelihood of a risk being realized. A lower probability means a lower risk.
M-SSR08	Study-Site RACT Metrics	-	Question	Question for discussion that is being scored. Sometime called Attribute Name.
M-SSR09	Study-Site RACT Metrics	-	[Rationale]	The rationale for the risk score.
M-SSR10	Study-Site RACT Metrics	-	Risk Score	The risk score for this question, as calculated in the source system.
M-SSR11	Study-Site RACT Metrics	-	Weight	The weight a score is given when calculating the total score for the Category.
M-SST97	Study-Site Metrics	Flags	Retention Flag	Retention Flag for the Study-Site.
M-SST98	Study-Site Metrics	Flags	Retention High Level Reason	High level reason for the Study-Site Retention Flag
M-SST52	Study-Site Metrics	Intervals	# Days Since Last Enrollment for Study-Site	Number of days between today's date and the most recent enrollment date at the study-site
M-SST63	Study-Site Metrics	Intervals	# Days Since Latest Site Visit	The number of dates since the most recent completed site visit.
M-SST76	Study-Site Metrics	Medians	Median # Days Between Site Visits	The median of the following cycle time across all site visits for a Study-Site: number of days between consecutive Site Visit Start Dates for completed site visits.
M-SST77	Study-Site Metrics	Medians	Median # Follow Up Items per Site Visit	The median of the number of follow up items per site visit for all completed site visits that occurred for a Study-Site.
M-SST86	Study-Site Metrics	Rates	# Subjects Enrolled per Site per Month Site Active	For a Study-Site that does not have a terminated date, the number of subjects enrolled since the Study-Site was initiated. For a Study-Site that has a terminated date, the number of subjects enrolled per month for the period between Study-Site initiation and latest subject enrolled at Study-Site
M-SST15.1	Study-Site Metrics	Ratios	% Enrolled to Total Planned at Study-Site	Ratio of number of enrolled subjects to total planned number of subjects for the study site.
M-SST54	Study-Site Metrics	Ratios	% of Total Enrolled in Study	The number of subjects enrolled at study-site divided by the number of subjects enrolled in the study
M-SST55	Study-Site Metrics	Ratios	% of Total Randomized in Study	The number of subjects randomized at study-site divided by the number of subjects randomized in study
M-SST56	Study-Site Metrics	Ratios	% of Total Screened in Study	The number of subjects screened at study-site divided by the number of subjects screened in study
M-SST94	Study-Site Metrics	Ratios	% Over/Under Enrolled	The percentage of planned subjects over (+) or under (-) enrolled for the Study-Site.
M-SST72	Study-Site Metrics	Ratios	% Randomized vs. Planned for Study-Site	The % of planned subjects randomized.
M-SST58	Study-Site Metrics	Ratios	% Subjects Early Terminated for Study	The number of subjects early terminated in study divided by the number of subjects enrolled in study
M-SST57	Study-Site Metrics	Ratios	% Subjects Early Terminated for Study-Site	The number of subjects early terminated at study-site divided by the number of subjects enrolled at study-site
M-SST19	Study-Site Metrics	Ratios	Closed Discrepancies per CRF	Number of Closed Discrepancies per CRF currently Present
M-SST23	Study-Site Metrics	Ratios	Closed Discrepancies per Enrolled Subject	Number of closed discrepancies per currently enrolled Subject
M-SST17	Study-Site Metrics	Ratios	Open Discrepancies per CRF	Number of Open Discrepancies per CRF currently Present
M-SST20	Study-Site Metrics	Ratios	Open Discrepancies per Enrolled Subject	Number of Open Discrepancies per currently enrolled Subject
M-SST87	Study-Site Metrics	Ratios	Screen Failure Rate	The number of subjects who failed screening divided by the number of subjects screened for the Study-Site.
M-SST18	Study-Site Metrics	Ratios	Total Discrepancies per CRF	Number of all Discrepancies (Open or Closed) per CRF currently Present
M-SST21	Study-Site Metrics	Ratios	Total Discrepancies per Enrolled Subject	Number of all Discrepancies (Open or Closed) per currently enrolled Subject
M-SST73	Study-Site Metrics	Statistics	1st Site Visit Date since Site Initiated	The Site Visit Start Date of the first site visit that occurred after the Site Initiated Date.
M-SST41	Study-Site Metrics	Statistics	1st Subject Completed Date	Earliest date on which a subject completed the study
M-SST40	Study-Site Metrics	Statistics	1st Subject Withdrawn Date	Earliest date on which a subject withdrew (Status is Early Terminated) from the study
M-SST59	Study-Site Metrics	Statistics	Avg # Days Document Outstanding	Average number of days between Document Sent date and today's date,
M-SST60	Study-Site Metrics	Statistics	Avg # Days from Document Sent to Document Received	Average number of days between Document Sent date and Document Received Date
M-SST24.1	Study-Site Metrics	Statistics	Avg Duration of All Discrepancies	For all discrepancies ever open at a study-site, the average number of days they were open.
M-SST29	Study-Site Metrics	Statistics	Avg Duration of Closed Discrepancies	For those discrepancies that are closed, the average number of days from creation to Closed.
M-SST24	Study-Site Metrics	Statistics	Avg Duration of Currently Open Discrepancies	For all open discrepancies at a study-site, the average number of days open
TA-SUBJ02	Study-Site Metrics	Statistics	Initial Informed Consent Date	Earliest Informed Consent date for a subject
M-SST74	Study-Site Metrics	Statistics	Latest Site Visit Completed Date	Most recent of all Site Visit Completed Dates for a Site
M-SST75	Study-Site Metrics	Statistics	Latest Site Visit Start Date	Most recent of all Site Visit Completed Dates for a Site
M-SST101	Study-Site Metrics	Statistics	Latest Site Visit Type	Visit type of the most recent of all Site Visit Completed Dates for a Site
M-SST45	Study-Site Metrics	Statistics	Latest Subject Completed Date	Most recent date on which a subject completed the study
M-SST24.3	Study-Site Metrics	Statistics	Max Duration of All Discrepancies	For all discrepancies ever open at a study-site, the maximum number of days they were open.
M-SST31	Study-Site Metrics	Statistics	Max Duration of Closed Discrepancies	For all closed discrepancies at a study-site, the maximum number of days it took to close them.
M-SST28	Study-Site Metrics	Statistics	Max Duration of Currently Open Discrepancies	For all discrepancies currently open, the maximum number of days any of them has been open.
M-SST24.2	Study-Site Metrics	Statistics	Min Duration of All Discrepancies	For all discrepancies ever open at a study-site, the minimum number of days they were open.
M-SST30	Study-Site Metrics	Statistics	Min Duration of Closed Discrepancies	For all closed discrepancies at a study-site, the minimum number of days it took to close them.
M-SST27	Study-Site Metrics	Statistics	Min Duration of Currently Open Discrepancies	For all open discrepancies at a study-site, the minimum number of days open
M-SST78	Study-Site Metrics	Statistics	Next Site Visit Date	Earliest Site Visit with Start Visit after today.
M-SST100	Study-Site Metrics	Statistics	Next Site Visit Type	Visit type of the Earliest Site Visit with Start Visit after today.
TA-SUBJ04	Subject Metrics	Actual Milestones	1st Visit Date	The date of the first post-enrollment visit for the subject.
TA-SUBJ09	Subject Metrics	Actual Milestones	[Last Visit Date]	The Last Visit Date for the Subject.
TA-SUBJ05	Subject Metrics	Actual Milestones	Latest Visit Date	The Latest Visit Date for the Subject.
TA-SUBJ06	Subject Metrics	Subject Visits	# Subject Visits Completed	The number of subject visits that have been completed.
TA-SUBJ07	Subject Metrics	Subject Visits	# Subject Visits Overdue	The number of subject visits that have been planned up to today's date but have not been completed.
TA-SUBJ08	Subject Metrics	Subject Visits	# Subject Visits Planned	The number of subject visits planned after today's date.
TA-SUBJ03	Subject Metrics	Transactional Data	Current Status Comment	Subject Status Comments
TA-SUBJ01	Subject Metrics	Transactional Data	Current Subject Status	Subject Status
TA-SUBJ10	Subject Metrics	Transactional Data	SDV Required	Indicates whether or not Source Data Verification (SDV) is required for the subject.
M-SBVT03	Subject Visit	Subject Visits	Subject Visit Completed Date	The Subject Visit Completed Date.
M-SBVT04	Subject Visit	Subject Visits	Subject Visit Completed Flag	Indicates whether the Subject Visit was completed.
M-SBVT05	Subject Visit	Subject Visits	Subject Visit Description	The Subject Visit Description.
M-SBVT06	Subject Visit	Subject Visits	Subject Visit Due Date	The Subject Visit Due Date.
M-SBVT07	Subject Visit	Subject Visits	Subject Visit Max Due Date	The maximum date on which the subject visit would be due.
M-SBVT08	Subject Visit	Subject Visits	Subject Visit Min Due Date	The minimum date on which the subject visit would be due.
M-SBVT09	Subject Visit	Subject Visits	Subject Visit Planned Date	The Subject Visit Planned Date
M-SBVT10	Subject Visit	Subject Visits	Subject Visit Protocol Deviation	Indicates whether there is a protocol deviation on the subject visit.
M-SBVT11	Subject Visit	Subject Visits	Subject Visit Protocol Violation	Indicates whether there is a protocol violation on the subject visit.
M-SBVT12	Subject Visit	Subject Visits	Subject Visit Sequence	The Subject Visit Sequence.
M-SBVT13	Subject Visit	Subject Visits	Subject Visit Template Version	The Subject Visit Template Version.
M-SBVT14	Subject Visit	Subject Visits	Subject Visit Type	The Subject Visit Type.
M-TA10	Therapeutic Area Metrics	Counts	# Studies	The number of study records.
M-TA27	Therapeutic Area Metrics	Medians	Median # Days Between Site Visits	The median of the following cycle time across all site visits for a Therapeutic Area: number of days between consecutive Site Visit Start Dates for completed site visits.
M-TA16	Therapeutic Area Metrics	Medians	[Median # Protocol Amendments per Study]	The median of the number of protocol amendments that occurred for all studies in a Therapeutic Area.
M-TA25	Therapeutic Area Metrics	Medians	[Median 1st Site Initiated to Last Site Initiated (# Days)]	The median of the following cycle time across all studies in a Therapeutic Area: 1st Site Initiated for Date Study to Last Site Initiated Date for Study.
M-TA03	Therapeutic Area Metrics	Medians	Median 1st Site Initiated to Latest Site Initiated (# Days)	The median of the following cycle time across all studies in a Therapeutic Area: 1st Site Initiated Date for a Study to Latest Site Initiated Date for a Study.
M-TA22	Therapeutic Area Metrics	Medians	[Median Critical Document Package Complete to Site Initiated (# Days)]	The median of the following cycle time across all Study-Sites in a Therapeutic Area: Critical Document Package Completed Date to Site Initiated Date.
M-TA05	Therapeutic Area Metrics	Medians	Median Initial IRB/EC Approval to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Therapeutic Area: Initial IRB/EC Approval Date to 1st Subject 1st Visit Date.
M-TA06	Therapeutic Area Metrics	Medians	Median Initial IRB/EC Approval to Site Initiated (# Days)	The median of the following cycle time across all Study-Sites in a Therapeutic Area: Initial IRB/EC Approval Date to Site Initiated Date.
M-TA26	Therapeutic Area Metrics	Medians	[Median Last Subject Last Visit to Database Lock (# Days)]	The median of the following cycle time across all studies in a Therapeutic Area: Last Subject Last Visit Date for Study to Database Lock Date.
M-TA07	Therapeutic Area Metrics	Medians	[Median Protocol Approved to 1st Site Initiated (# Days)]	The median of the following cycle time across all studies for Therapeutic Area: Protocol Approved Date to 1st Site Initiated Date for Study.
M-TA08	Therapeutic Area Metrics	Medians	[Median Protocol Approved to 1st Subject Enrolled (# Days)]	The median of the following cycle time across all studies in a Therapeutic Area: Protocol Approved Date to 1st Subject Enrolled Date for Study.
M-TA24	Therapeutic Area Metrics	Medians	[Median Protocol Approved to 1st Subject Randomized (# Days)]	The median of the following cycle time across all studies in a Therapeutic Area: Protocol Approved Date to 1st Subject Randomized Date for Study.
M-TA23	Therapeutic Area Metrics	Medians	[Median Protocol Approved to 1st Subject Screened (# Days)]	The median of the following cycle time across all studies in a Therapeutic Area: Protocol Approved Date to 1st Subject Screened Date for Study.
M-TA09	Therapeutic Area Metrics	Medians	Median Site Initiated to 1st Subject 1st Visit (# Days)	The median of the following cycle time across all Study-Sites in a Therapeutic Area: Site Initiated for Study-Site to 1st Subject 1st Visit Date for Study-Site.
M-TA11	Therapeutic Area Metrics	Medians	Median Site Visit Completed to Follow Up Item Completed (# Days)	The median of the following cycle time across all completed site visits in a Therapeutic Area: Site Visit Completed Date to Follow Up Item Completed Date.
M-TA12	Therapeutic Area Metrics	Medians	Median Site Visit Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits for a Therapeutic Area: Site Visit Completed Date to Visit Report Approved Date.
M-TA13	Therapeutic Area Metrics	Medians	Median Site Visit Completed to Visit Report Completed (# Days)	The median of the following cycle time across all completed site visits for a Therapeutic Area: Site Visit Completed Date to Visit Report Completed Date.
M-TA14	Therapeutic Area Metrics	Medians	Median Site Visit Start to Site Visit Completed (# Days)	The median of the following cycle time across all completed site visits for a Therapeutic Area: Site Visit Start Date to Site Visit Completed Date.
M-TA15	Therapeutic Area Metrics	Medians	Median Visit Report Completed to Visit Report Approved (# Days)	The median of the following cycle time across all completed site visits in a Therapeutic Area: Visit Report Completed Date to Visit Report Approved Date.
M-TA20	Therapeutic Area Metrics	Ratios	% Sites Recruiting 0 Subjects	The percentage of initiated sites that have not enrolled any subjects, for all Study-Sites in a Therapeutic Area.
M-TA21	Therapeutic Area Metrics	Ratios	% Sites Recruiting 1 or More Subjects	the number of sites recruiting one or more Subjects divided by the number of Sites Initiated.
M-TA01	Therapeutic Area Metrics	Ratios	% Sites Recruiting at Least 90% of Planned Subjects	the number of sites recruiting at least 90% of planned subjects divided by the number of Sites Initiated.
TA-SUBJ11	Subject Metrics	Transactional Data	SDV Last Updated Source	Indicates the source that last populated SDV Required field.
M-STD115	Study Metrics	Counts	# Initial Subjects SDV	The initial number of subjects for the Study-Site that will be selected for Source Data Verification (SDV). This is the default for all Study-Sites in the Study.
M-STD116	Study Metrics	Ratios	% Subjects Auto SDV	The percentage of subjects that will be selected for Source Data Verification (SDV). This is the default for all Study-Sites in the Study.
M-SRG36	Study-Region Metrics	Counts	# Initial Subjects SDV	The initial number of subjects for the Study-Site that will be selected for Source Data Verification (SDV). This is the default for all Study-Sites in the Study-Region.
M-SRG37	Study-Region Metrics	Ratios	% Subjects Auto SDV	The percentage of subjects that will be selected for Source Data Verification (SDV). This is the default for all Study-Sites in the Study-Region.
M-SST110	Study-Site Metrics	-	SDV Policy	The Source Data Verification (SDV) policy for the study-site, whether complete (all subjects SDV) partial (use formula to flag subjects for SDV) or external (SDV is determined by a system that integrates with CTMS).
M-PDSS01	Protocol Deviation (Study-Site)	-	[Action Required]	This describes any action required on the Protocol Deviation.
M-PDSS02	Protocol Deviation (Study-Site)	-	[Closure Date]	The date when the Protocol Deviation was closed
M-PDSS03	Protocol Deviation (Study-Site)	-	[Category]	Internal identifying category for the protocol deviation
M-PDSS04	Protocol Deviation (Study-Site)	-	[Description]	Free-form text description of the deviaIQtion.
M-PDSS05	Protocol Deviation (Study-Site)	-	[ID]	Unique identifier for each protocol deviation that occurred on that particular study. This value must be unique by the Protocol Deviation Source.
M-PDSS06	Protocol Deviation (Study-Site)	-	[Identified Date]	The date when the Protocol Deviation was identified.
M-PDSS07	Protocol Deviation (Study-Site)	-	[Issue Escalation Flag]	Indicates if an escalation has been raised against the protocol deviation.
M-PDSS08	Protocol Deviation (Study-Site)	-	[Level]	The level at which the Protocol Deviation.
M-PDSS09	Protocol Deviation (Study-Site)	-	[Occurence Date]	The date when the Protocol Deviation occurred
M-PDSS10	Protocol Deviation (Study-Site)	-	[Reported By]	The details of who reported the Protocol Deviation
M-PDSS11	Protocol Deviation (Study-Site)	-	[Reported to IRB/IEC Flag]	A flag indicating whether a deviation is reported to IRB Ethics committee
M-PDSS12	Protocol Deviation (Study-Site)	-	[Resolution]	The resolution details of the protocol deviation.
M-PDSS13	Protocol Deviation (Study-Site)	-	[Resolution Date]	The resolution date of the protocol deviation
M-PDSS14	Protocol Deviation (Study-Site)	-	[Severity]	The severity of the Protocol Deviation.
M-PDSS15	Protocol Deviation (Study-Site)	-	[Subcategory]	The sub-category for the Protocol Deviation
M-PDSS16	Protocol Deviation (Study-Site)	-	[Source]	The originating source of the Protocol Deviation.
M-PDSS17	Protocol Deviation (Study-Site)	-	[Study Deviation Class]	The deviation class that a deviation raised belongs to
M-PDSS18	Protocol Deviation (Study-Site)	-	[Subject Auth to Continue Flag]	Flag denoting the authorization for Subject(s) to continue based on Protocol Deviations that have occurred
M-PDSU01	Protocol Deviation (Subject)	-	[Action Required]	This describes any action required on the Protocol Deviation.
M-PDSU02	Protocol Deviation (Subject)	-	[Clinical Review Date]	The date the Protocol Deviation was reviewed by the clinician
M-PDSU03	Protocol Deviation (Subject)	-	[Clinical Review Potential PDAL Flag]	Based on Protocol Deviation review, Yes/No flag depicted depending on whether PD is considered to be a Potential PDAL case
M-PDSU04	Protocol Deviation (Subject)	-	[Clinical Review Status]	Clinical PD Review Status (complete, pending)
M-PDSU05	Protocol Deviation (Subject)	-	[Clinical Reviewer]	Name of the clinician performing the review
M-PDSU06	Protocol Deviation (Subject)	-	[Clinical Team Meeting Date]	Date of clinical team meeting where the discussion and decision for the means of Investigator Notification for protocol deviation cases that could lead to unsafe use of study drug.
M-PDSU07	Protocol Deviation (Subject)	-	[Code]	Internal identifying code for the protocol deviation in the code file.
M-PDSU08	Protocol Deviation (Subject)	-	[Status]	Status of the Protocol Deviation.
M-PDSU09	Protocol Deviation (Subject)	-	[Description]	Free-form text description of the deviation.
M-PDSU10	Protocol Deviation (Subject)	-	[ID]	Unique identifier for each protocol deviation that occurred on that particular study. This value must be unique by the Protocol Deviation Source.
M-PDSU11	Protocol Deviation (Subject)	-	[Identified Date]	The date when the Protocol Deviation was identified.
M-PDSU12	Protocol Deviation (Subject)	-	[Issue Escalation Flag]	Indicates if an escalation has been raised against the protocol deviation.
M-PDSU13	Protocol Deviation (Subject)	-	[Level]	The level at which the Protocol Deviation.
M-PDSU14	Protocol Deviation (Subject)	-	[Occurrence Date]	The date when the Protocol Deviation occurred
M-PDSU15	Protocol Deviation (Subject)	-	[Reported By]	The details of who reported the Protocol Deviation
M-PDSU16	Protocol Deviation (Subject)	-	[Reported to IRB/IEC Flag]	A flag indicating whether a deviation is reported to IRB Ethics committee
M-PDSU17	Protocol Deviation (Subject)	-	[Resolution]	The resolution details of the Protocol Deviation.
M-PDSU18	Protocol Deviation (Subject)	-	[Severity]	The severity of the Protocol Deviation.
M-PDSU19	Protocol Deviation (Subject)	-	[Source]	The originating source of the Protocol Deviation.
M-PDSU20	Protocol Deviation (Subject)	-	[Subcategory]	The sub-category for the Protocol Deviation
M-PDSU21	Protocol Deviation (Subject)	-	[Subject Auth to Continue Flag]	Flag denoting the authorization for Subject(s) to continue based on Protocol Deviations that have occurred
M-PDSU22	Protocol Deviation (Subject)	-	[Clinical Review PD Comments]	Protocol Deviation Review Clinician Review Comments
M-PDSU23	Protocol Deviation (Subject)	-	[Category]	The category for the Protocol Deviation
M-SST109	Study-Site Metrics	Counts	[# Protocol Deviations (Subject)]	The total number of Subject related Protocol Deviations.
TA-SUBJ12	Subject Metrics	Counts	[# Protocol Deviations (Study-Site)]	The total number of Study-Site related Protocol Deviations.

Oracle Clinical Sources for OHSCDA Presentation Catalog

There are two tables in this section:

• Table B-3,Presentation Catalog - Oracle Clinical Sourceslists Oracle Clinical sources for presentation catalog.

• Table B-4, Aliases for Table Names lists the aliases used for table names in Table B-3.

Oracle Clinical Sources

Table B-3 describes how OHSCDA populates each column from an Oracle Clinical database. Each Measure has an ID number, which is provided for cross-reference to other tables in this Appendix. To display the information compactly, Table B-3 uses aliases for table names. Refer to Table B-4 for the correspondence between aliases and table names.

Table B-3 Presentation Catalog - Oracle Clinical Sources

Attribute ID	Source Table/Column	Comments/Details
AD02-02	-	Not sourced from OC
AD02-03	-	Not sourced from OC
AD02-04	-	Not sourced from OC
AD02-05	-	Not sourced from OC
AD02-06	-	Not sourced from OC
AD02-07	-	Not sourced from OC
AD02-08	-	Not sourced from OC
AD02-09	-	Not sourced from OC
AD02-10	-	Not sourced from OC
AD02-11	-	Not sourced from OC
AD02-12	-	Not sourced from OC
AD02-13	-	Not sourced from OC
AD02-14	-	Not sourced from OC
AD02-15	-	Not sourced from OC
AD02-16	-	Not sourced from OC
AD02-17	-	Not sourced from OC
AD02-18	-	Not sourced from OC
AD02-19	-	Not sourced from OC
AD02-20	-	Not sourced from OC
AD02-21	-	Not sourced from OC
AD02-22	-	Not sourced from OC
AD02-23	-	Not sourced from OC
AD02-24	-	Not sourced from OC
AD02-25	-	Not sourced from OC
AD02-26	-	Not sourced from OC
AD02-27	-	Not sourced from OC
AD02-28	-	Not sourced from OC
AD02-29	-	Not sourced from OC
AD02-30	-	Not sourced from OC
AD02-31	-	Not sourced from OC
AD02-32	-	Not sourced from OC
AD02-33	-	Not sourced from OC
AD02-34	-	Not sourced from OC
AD02-35	-	Not sourced from OC
AD02-36	-	Not sourced from OC
AD02-37	-	Not sourced from OC
AD02-38	-	Not sourced from OC
AD02-39	-	Not sourced from OC
AD02-40	-	Not sourced from OC
AD02-41	-	Not sourced from OC
AD02-42	-	Not sourced from OC
AD02-43	-	Not sourced from OC
AD02-44	-	Not sourced from OC
AD02-45	-	Not sourced from OC
AD02-46	-	Not sourced from OC
AD02-47	-	Not sourced from OC
AD02-48	-	Not sourced from OC
AD02-49	-	Not sourced from OC
AD02-50	-	Not sourced from OC
AD02-51	-	Not sourced from OC
AD02-52	-	Not sourced from OC
AD02-53	-	Not sourced from OC
AD02-54	-	Not sourced from OC
AD02-55	-	Not sourced from OC
AD02-56	-	Not sourced from OC
AD02-57	-	Not sourced from OC
AD02-58	-	Not sourced from OC
AD02-59	-	Not sourced from OC
AD02-60	-	Not sourced from OC
AD02-61	-	Not sourced from OC
AD02-62	-	Not sourced from OC
AD02-63	-	Not sourced from OC
AD02-64	-	Not sourced from OC
AD02-65	-	Not sourced from OC
AD02-66	-	Not sourced from OC
AD02-67	-	Not sourced from OC
AD02-68	-	Not sourced from OC
AD02-69	-	Not sourced from OC
AD02-70	-	Not sourced from OC
AD02-71	-	Not sourced from OC
AD02-72	-	Not sourced from OC
AD02-73	-	Not sourced from OC
AD02-74	-	Not sourced from OC
AD02-75	-	Not sourced from OC
AD02-76	-	Not sourced from OC
AD02-77	-	Not sourced from OC
AD02-78	-	Not sourced from OC
AD02-79	-	Not sourced from OC
AD02-80	-	Not sourced from OC
AD02-81	-	Not sourced from OC
AD02-82	-	Not sourced from OC
AD02-83	-	Not sourced from OC
AD02-84	-	Not sourced from OC
AD02-85	-	Not sourced from OC
AD02-86	-	Not sourced from OC
AD02-87	-	Not sourced from OC
AD02-88	-	Not sourced from OC
AD02-89	-	Not sourced from OC
AD02-90	-	Not sourced from OC
AD02-91	-	Not sourced from OC
AD02-92	-	Not sourced from OC
AD02-93	-	Not sourced from OC
AD02-94	-	Not sourced from OC
AD02-95	-	Not sourced from OC
AD02-96	-	Not sourced from OC
AD02-97	-	Not sourced from OC
AD02-98	-	Not sourced from OC
AD02-99	-	Not sourced from OC
AD02-100	-	Not sourced from OC
AD02-101	-	Not sourced from OC
AD02-102	-	Not sourced from OC
AD02-103	-	Not sourced from OC
AD02-104	-	Not sourced from OC
AD02-105	-	Not sourced from OC
AD02-106	-	Not sourced from OC
AD02-107	-	Not sourced from OC
AD02-108	-	Not sourced from OC
AD02-109	-	Not sourced from OC
AD02-110	-	Not sourced from OC
AD02-111	-	Not sourced from OC
AD02-112	-	Not sourced from OC
AD02-113	-	Not sourced from OC
AD02-114	-	Not sourced from OC
AD02-115	-	Not sourced from OC
AD02-116	-	Not sourced from OC
AD02-117	-	Not sourced from OC
AD02-118	-	Not sourced from OC
AD02-119	-	Not sourced from OC
AD02-120	-	Not sourced from OC
AD02-121	-	Not sourced from OC
AD02-122	-	Not sourced from OC
AD02-123	-	Not sourced from OC
AD02-124	-	Not sourced from OC
AD02-125	-	Not sourced from OC
AD02-126	-	Not sourced from OC
AD02-127	-	Not sourced from OC
AD02-128	-	Not sourced from OC
AD02-129	-	Not sourced from OC
AD02-130	-	Not sourced from OC
AD02-131	-	Not sourced from OC
AD02-132	-	Not sourced from OC
AD02-133	-	Not sourced from OC
AD02-134	-	Not sourced from OC
AD02-135	-	Not sourced from OC
AD02-136	-	Not sourced from OC
AD02-137	-	Not sourced from OC
AD02-138	-	Not sourced from OC
AD02-139	-	Not sourced from OC
AD02-140	-	Not sourced from OC
AD02-141	-	Not sourced from OC
AD02-142	-	Not sourced from OC
AD02-143	-	Not sourced from OC
AD02-144	-	Not sourced from OC
AD02-145	-	Not sourced from OC
AD02-146	-	Not sourced from OC
AD02-147	-	Not sourced from OC
AD02-148	-	Not sourced from OC
AD02-149	-	Not sourced from OC
AD02-150	-	Not sourced from OC
AD02-151	-	Not sourced from OC
AD02-152	-	Not sourced from OC
AD02-153	-	Not sourced from OC
AD02-154	-	Not sourced from OC
AD02-155	-	Not sourced from OC
AD02-156	-	Not sourced from OC
AD02-157	-	Not sourced from OC
AD04-01	ocl_regions.continent	where the continent is composed of country, and the country has only one continent. Else null.
AD04-03	os.country and inv.country	-
AD04-04	os.state and inv.country	-
AD04-05	-	Not sourced from OC
AD04-06	os.city and inv.city	-
AD04-07	os.postal_code and inv.postal_code	-
AD05-01	inv.last_name	-
AD05-02	inv.first_name	-
AD05-03	inv.first_name ||' '|| inv.last_name	-
AD05-04	inv.address _line%	catenation of 3 lines
AD05-05	inv.city	-
AD05-06	inv.postal_code	-
AD05-07	inv.state	-
AD05-08	inv.country	-
AD05-09	inv.continent	-
AD05-10	-	Not sourced from OC
AD05-11	-	Not sourced from OC
AD05-12	-	Not sourced from OC
AD05-13	-	Not sourced from OC
AD05-14	-	Not sourced from OC
AD05-15	-	Not sourced from OC
AD05-16	-	Not sourced from OC
AD05-17	-	Not sourced from OC
AD05-18	-	Not sourced from OC
AD05-19	-	Not sourced from OC
AD07-01	pm.product_name	-
AD07-02	-	Not sourced from OC
AD07-03	pm.pm_type_code	-
AD07-04	-	Not sourced from OC
AD07-07	-	Not sourced from OC
AD07-08	-	Not sourced from OC
AD07-09	-	Not sourced from OC
AD08-01	site.name	-
AD08-02	site.state	-
AD08-03	site.country	-
AD08-04	region_components.part_of_region_code	Continent, given country
AD08-05	-	Not sourced from OC
AD08-06	-	Not sourced from OC
AD08-07	site.address_line_1	-
AD08-08	site.address_line_2	-
AD08-09	site.address_line_3	-
AD08-10	site.postal_code	-
AD08-11	-	Not sourced from OC
AD08-12	site.city	-
AD09-01	os.study	-
AD09-02	cs.short_title	-
AD09-03	os.program_code	-
AD09-04	os.project_code	-
AD09-05	-	Not sourced from OC
AD09-06	os.project_code	If all received CRFs have a single Data Capture mode, that is the mode of the study. If mixed, the 'Paper and EDC'; If no data collected, mode is 'Unknown'.
AD09-07	-	Not sourced from OC
AD09-08	-	Not sourced from OC
AD09-09	-	Not sourced from OC
AD09-10	-	Not sourced from OC
AD09-11	-	Not sourced from OC
AD09-12	-	Not sourced from OC
AD09-13	-	Not sourced from OC
AD09-14	-	Not sourced from OC
AD09-15	-	Not sourced from OC
AD09-16	-	Not sourced from OC
AD09-17	-	Not sourced from OC
AD09-18	-	Not sourced from OC
AD09-19	-	Not sourced from OC
AD09-20	-	Not sourced from OC
AD09-22	-	Not sourced from OC
AD09-23	-	Not sourced from OC
AD09-24	-	Not sourced from OC
AD09-25	-	Not sourced from OC
AD09-26	-	Not sourced from OC
AD09-27	-	Not sourced from OC
AD09-28	-	Not sourced from OC
AD09-29	-	Not sourced from OC
AD09-30	-	Not sourced from OC
AD09-31	-	Not sourced from OC
AD09-32	-	Not sourced from OC
AD09-33	-	Not sourced from OC
AD09-34	-	Not sourced from OC
AD09-35	-	Not sourced from OC
AD09-36	-	Not sourced from OC
AD09-38	-	Not sourced from OC
AD09-39	-	Not sourced from OC
AD09-40	-	Not sourced from OC
AD09-41	-	Not sourced from OC
AD09-42	-	Not sourced from OC
AD09-43	-	Not sourced from OC
AD09-44	-	Not sourced from OC
AD09-45	-	Not sourced from OC
AD09-46	-	Not sourced from OC
AD09-47	-	Not sourced from OC
AD09-48	-	Not sourced from OC
AD09-49	-	Not sourced from OC
AD09-50	-	Not sourced from OC
AD09-51	-	Not sourced from OC
AD09-52	-	Not sourced from OC
AD09-53	-	Not sourced from OC
AD09-54	-	Not sourced from OC
AD09-55	-	Not sourced from OC
AD09-56	-	Not sourced from OC
AD09-57	-	Not sourced from OC
AD09-58	-	Not sourced from OC
AD09-59	-	Not sourced from OC
AD09-60	-	Not sourced from OC
AD09-61	-	Not sourced from OC
AD09-62	-	Not sourced from OC
AD09-63	-	Not sourced from OC
AD09-64	-	Not sourced from OC
AD09-65	-	Not sourced from OC
AD09-66	-	Not sourced from OC
AD09-67	-	Not sourced from OC
AD09-68	-	Not sourced from OC
AD09-69	-	Not sourced from OC
AD09-70	-	Not sourced from OC
AD09-71	-	Not sourced from OC
AD09-72	-	Not sourced from OC
AD09-73	-	Not sourced from OC
AD09-74	-	Not sourced from OC
AD10-01	site.name	-
AD10-02	ss.study_site	-
AD10-03	-	Not sourced from OC
AD10-04	cs.study	-
AD10-05	os.program_code	-
AD10-06	os.project_code	-
AD10-07	ep.planned_start_date	-
AD10-08	ep.planned_target_date	-
AD10-10	min(pp.patient_enrollment_date)	-
AD10-22	inv.first_name ||' '|| inv.last_name	-
AD10-24	-	Not sourced from OC
AD10-25	-	If all received CRFs have a single Data Capture mode, that is the mode of the study. If mixed, the 'Paper and EDC'; If no data collected, mode is 'Unknown'.
AD10-26	-	Not sourced from OC
AD10-29	sites.active_flag	Not sourced from OC
AD10-31	-	Not sourced from OC
AD10-32	sites.city	Not sourced from OC
AD10-33	sites.postal_code	Not sourced from OC
AD10-34	sites.address_line_1	Not sourced from OC
AD10-35	sites.address_line_2	Not sourced from OC
AD10-36	sites.address_line_3	Not sourced from OC
AD10-37	-	In Business Model only - concatenation of Study #, Site #, P Investigator Last Name
AD10-38	-	Not sourced from OC
AD10-39	-	Not sourced from OC
AD10-40	cs.study_status_type_code	-
AD10-41	-	Not sourced from OC
AD10-42	-	Not sourced from OC
AD10-43	-	Not sourced from OC
AD10-44	-	Not sourced from OC
AD10-45	-	Not sourced from OC
AD10-46	-	Not sourced from OC
AD10-47	-	Not sourced from OC
AD10-48	-	Not sourced from OC
AD10-49	-	Not sourced from OC
AD10-50	-	Not sourced from OC
AD10-51	-	Not sourced from OC
AD10-52	-	Not sourced from OC
AD10-53	-	Not sourced from OC
AD10-54	-	Not sourced from OC
AD10-55	-	Not sourced from OC
AD10-56	-	Not sourced from OC
AD10-57	-	Not sourced from OC
AD10-58	-	Not sourced from OC
AD10-59	-	Not sourced from OC
AD10-60	-	Not sourced from OC
AD10-61	-	Not sourced from OC
AD10-62	-	Not sourced from OC
AD10-63	-	Not sourced from OC
AD10-64	-	Not sourced from OC
AD10-65	-	Not sourced from OC
AD10-66	-	Not sourced from OC
AD10-67	-	Not sourced from OC
AD10-68	-	Not sourced from OC
AD10-69	-	Not sourced from OC
AD10-70	-	Not sourced from OC
AD10-71	-	Not sourced from OC
AD10-72	-	Not sourced from OC
AD10-73	-	Not sourced from OC
AD10-74	-	Not sourced from OC
AD10-75	-	Not sourced from OC
AD10-76	-	Not sourced from OC
AD10-77	-	Not sourced from OC
AD11-01	cs.study	exclude GLIB
AD11-02	dci.name	-
AD11-03	dci.help_text	-
AD11-04	dci.short_name	-
AD11-05	dcis.dci_id	-
AD12-01	book.name	-
AD12-02	cs.study	exclude GLIB
AD13-01	cs.study	exclude GLIB
AD13-02	proc.name	-
AD13-03	proc.description	-
AD13-04	proc.procedure_type_code	-
AD14-01	-	Not sourced from OC
AD14-02	-	Not sourced from OC
AD14-03	-	Not sourced from OC
AD14-04	-	Not sourced from OC
AD14-05	-	Not sourced from OC
AD14-06	-	Not sourced from OC
AD14-07	-	Not sourced from OC
AD14-08	-	Not sourced from OC
AD14-09	-	Not sourced from OC
AD14-10	-	Not sourced from OC
AD15-01	-	Not sourced from OC
AD15-02	-	Not sourced from OC
AD15-03	-	Not sourced from OC
AD15-04	-	Not sourced from OC
AD15-05	-	Not sourced from OC
AD15-06	-	Not sourced from OC
AD15-07	-	Not sourced from OC
AD15-08	-	Not sourced from OC
AD15-09	-	Not sourced from OC
AD15-10	-	Not sourced from OC
AD15-11	-	Not sourced from OC
AD15-12	-	Not sourced from OC
AD15-13	-	Not sourced from OC
AD15-15	-	Not sourced from OC
AD15-16	-	Not sourced from OC
AD15-17	-	Not sourced from OC
AD15-18	-	Not sourced from OC
AD15-19	-	Not sourced from OC
AD16-01	-	Not sourced from OC
AD16-02	-	Not sourced from OC
AD16-03	-	Not sourced from OC
AD16-04	-	Not sourced from OC
AD16-05	-	Not sourced from OC
AD16-06	-	Not sourced from OC
AD16-07	-	Not sourced from OC
AD16-08	-	Not sourced from OC
AD16-09	-	Not sourced from OC
AD16-10	-	Not sourced from OC
AD16-11	-	Not sourced from OC
AD16-12	-	Not sourced from OC
AD16-13	-	Not sourced from OC
AD16-14	-	Not sourced from OC
AD16-15	-	Not sourced from OC
AD16-16	-	Not sourced from OC
AD17-01	-	Not sourced from OC
AD17-02	-	Not sourced from OC
AD17-03	-	Not sourced from OC
AD17-04	-	Not sourced from OC
AD17-05	-	Not sourced from OC
AD17-06	-	Not sourced from OC
AD17-07	-	Not sourced from OC
AD17-08	-	Not sourced from OC
AD17-09	-	Not sourced from OC
AD17-10	-	Not sourced from OC
AD17-11	-	Not sourced from OC
AD17-12	-	Not sourced from OC
AD17-13	-	Not sourced from OC
AD17-14	-	Not sourced from OC
AD17-15	-	Not sourced from OC
AD17-16	-	Not sourced from OC
AD17-17	-	Not sourced from OC
AD17-18	-	Not sourced from OC
AD17-19	-	Not sourced from OC
AD17-20	-	Not sourced from OC
AD17-21	-	Not sourced from OC
AD17-22	-	Not sourced from OC
AD17-23	-	Not sourced from OC
AD17-24	-	Not sourced from OC
AD17-25	-	Not sourced from OC
AD17-26	-	Not sourced from OC
AD17-27	-	Not sourced from OC
AD17-28	-	Not sourced from OC
AD17-29	-	Not sourced from OC
AD17-30	-	Not sourced from OC
AD17-31	-	Not sourced from OC
AD17-32	-	Not sourced from OC
AD17-33	-	Not sourced from OC
AD17-34	-	Not sourced from OC
AD17-35	-	Not sourced from OC
AD17-36	-	Not sourced from OC
AD17-37	-	Not sourced from OC
AD17-38	-	Not sourced from OC
AD17-39	-	Not sourced from OC
AD17-40	-	Not sourced from OC
AD17-41	-	Not sourced from OC
AD17-42	-	Not sourced from OC
AD17-43	-	Not sourced from OC
AD17-44	-	Not sourced from OC
AD17-45	-	Not sourced from OC
AD17-46	-	Not sourced from OC
AD17-47	-	Not sourced from OC
AD18-01	-	Not sourced from OC
AD18-02	-	Not sourced from OC
AD18-03	-	Not sourced from OC
AD18-04	-	Not sourced from OC
AD18-05	-	Not sourced from OC
AD18-06	-	Not sourced from OC
AD18-07	-	Not sourced from OC
AD18-08	-	Not sourced from OC
AD18-09	-	Not sourced from OC
AD18-10	-	Not sourced from OC
AD18-11	-	Not sourced from OC
AD18-12	-	Not sourced from OC
AD19-01	-	Not sourced from OC
AD19-02	-	Not sourced from OC
AD19-03	-	Not sourced from OC
AD19-04	-	Not sourced from OC
AD19-05	-	Not sourced from OC
AD19-06	-	Not sourced from OC
AD19-07	-	Not sourced from OC
AD19-08	-	Not sourced from OC
AD19-09	-	Not sourced from OC
AD20-01	-	Not sourced from OC
AD20-02	-	Not sourced from OC
AD20-03	-	Not sourced from OC
AD20-04	-	Not sourced from OC
AD20-05	-	Not sourced from OC
AD20-06	-	Not sourced from OC
AD20-07	-	Not sourced from OC
AD20-08	-	Not sourced from OC
AD21-01	-	Not sourced from OC
AD21-02	-	Not sourced from OC
AD21-03	-	Not sourced from OC
AD21-04	-	Not sourced from OC
AD21-05	-	Not sourced from OC
AD21-06	-	Not sourced from OC
AD21-07	-	Not sourced from OC
AD21-08	-	Not sourced from OC
AD21-09	-	Not sourced from OC
AD22-01	-	Not sourced from OC
AD22-02	-	Not sourced from OC
AD22-03	-	Not sourced from OC
AD22-04	-	Not sourced from OC
AD22-05	-	Not sourced from OC
AD22-06	-	Not sourced from OC
AD22-07	-	Not sourced from OC
AD22-08	-	Not sourced from OC
AD22-09	-	Not sourced from OC
AD22-10	-	Not sourced from OC
AD22-11	-	Not sourced from OC
AD22-12	-	Not sourced from OC
AD22-13	-	Not sourced from OC
M-ALL01	-	Not sourced from OC
M-ALL02	-	Not sourced from OC
M-ALL03	-	Not sourced from OC
M-ALL04	-	Not sourced from OC
M-ALL05	-	Not sourced from OC
M-ALL06	-	Not sourced from OC
M-ALL07	-	Not sourced from OC
M-ALL08	-	Not sourced from OC
M-ALL09	-	Not sourced from OC
M-ALL10	-	Not sourced from OC
M-ALL11	-	Not sourced from OC
M-ALL12	-	Not sourced from OC
M-ALL13	-	Not sourced from OC
M-ALL14	-	Not sourced from OC
M-ALL15	-	Not sourced from OC
M-ALL16	-	Not sourced from OC
M-ALL17	-	Not sourced from OC
M-ALL18	-	Not sourced from OC
M-ALL19	-	Not sourced from OC
M-ALL20	-	Not sourced from OC
M-ALL21	-	Not sourced from OC
M-DOC01	-	Not sourced from OC
M-DOC02	-	Not sourced from OC
M-DOC03	-	Not sourced from OC
M-DOC04	-	Not sourced from OC
M-DRS01	derh.discrepancy_rev_status_code	-
M-DRS02	sum(derh.next_status_ts - derh.creation_ts)	For each particular review status (the summation is needed in case the discrepancy enters the review status more than once)
M-DRS03	M-DRS02/(number of discrepancies that occupied a given review status)	-
M-DRS04	(M-DRS02/(number of discrepancies that occupied a given review status)) given currently open discrepancies only	-
M-DSC01	disc	count
M-DSC02	disc	count where not OBSOLETE and not irresolvable
M-DSC03	disc	count where discrepancy_status_code = OBSOLETE or irresolvable
M-DSC04	disc	count where disc.dcf_id is not null
M-DSC09	disc	count where irresolvable
M-DSC11	disc	close date - creation date given State = CLOSED; last ETL date - creation date given State = OPEN
M-DSC12	disc	last ETL date - creation date given State = OPEN
M-DSC15	close date - creation date	where State = CLOSED
M-FUI01	-	Not sourced from OC
M-FUI02	-	Not sourced from OC
M-FUI03	-	Not sourced from OC
M-PRG01	-	Not sourced from OC
M-PRG03	-	Not sourced from OC
M-PRG04	-	Not sourced from OC
M-PRG06	-	Not sourced from OC
M-PRG07	-	Not sourced from OC
M-PRG08	-	Not sourced from OC
M-PRG09	-	Not sourced from OC
M-PRG10	-	Not sourced from OC
M-PRG11	-	Not sourced from OC
M-PRG12	-	Not sourced from OC
M-PRG13	-	Not sourced from OC
M-PRG14	-	Not sourced from OC
M-PRG15	-	Not sourced from OC
M-PRG16	-	Not sourced from OC
M-PRG17	-	Not sourced from OC
M-PRG18	-	Not sourced from OC
M-PRG19	-	Not sourced from OC
M-PRG20	-	Not sourced from OC
M-PRG21	-	Not sourced from OC
M-PRG22	-	Not sourced from OC
M-PRG23	-	Not sourced from OC
M-PRG24	-	Not sourced from OC
M-RCF01	rdci.received_dcis	count where required entry passes are complete. For eCRF, this is Pass 1. For pCRF, it is Pass 1 unless second pass is required for the study.
M-RCF05	rdci	where received_dci_status_code = 'RECEIVED'
M-RCF06	rdci	where received_dci_status_code = 'PASS 1 STARTED
M-RCF07	rdci	count where PASS 1 COMPLETE
M-RCF08	rdci	where RECEIVED or PASS 1 STARTED
M-RCF09	rdci	where BLANK_FLAG = 'Y'
M-RCF10	rdci	count
M-RCF11	rdci	last ETL - log_in_ts, where RECEIVED
M-RCF13	rdci	count where rdci.received_dci_status_code in ('PASS 2 STARTED', 'PASS 2 PENDING')
M-RCF14	rdci	count where rdci.received_dci_status_code = 'PASS 2 COMPLETE'
M-RCF15	rdci	count where rdci.received_dci_status_code = 'PASS 2 PENDING'
M-RCF16	rdci	count where rdci.received_dci_status_code in ('PASS 1 COMPLETE', 'PASS 2 STARTED', 'PASS 2 PENDING')
M-RCF17	rdci	count where: rdci is paper (i.e. substr(rdci.document_number, 1,1) != 'R') and either received_dci_status_code = 'PASS 1 STARTED', if PASS 2 not required, or received_dci_status_code in ( 'PASS 1 COMPLETE', 'PASS 2 STARTED', 'PASS 2 PENDING')
M-RCF18	rdci	count where: (rdci is paper (i.e. substr(rdci.document_number, 1,1) != 'R') and either received_dci_status_code = 'PASS 1 STARTED', if PASS 2 not required, or received_dci_status_code in ( 'PASS 1 COMPLETE', 'PASS 2 STARTED', 'PASS 2 PENDING')) or /* eCRF */ received_dci_status_code = 'PASS 1 STARTED')
M-RCF19	rdci	count where received_dci_status_code = 'BATCH'
M-RCF20	rh	count where trans_type = 'SYS VER YES'
M-RCF21	rh	count where trans_type in ('SYS VER NO', 'SYS VER UNDONE', 'SYS VER DATACHG)
M-RCF21.1	rh	count where trans_type in ('SYS APP NO', 'SYS APP UNDONE', 'SYS APP DATACHG')
M-RCF22	rh	count where trans_type = 'SYS VER DATACHG'
M-RCF23	rh	count where trans_type = 'SYS VER NO', ' SYS VER UNDONE'
M-RCF24	rh	count where trans_type = 'SYS APP YES'
M-RCF25	rh	count where trans_type = ('SYS APP NO', 'SYS APP UNDONE')
M-RCF26	rh	count where trans_type = 'SYS APP DATACHG'
M-RCF29	rdci	count all received DCIs that are locked (data_lock_flag = 'Y') but not yet frozen (freeze_flag = 'N')
M-RCF29.1	rdci	count where TA-RCRF28 is 'Y'
M-RCF30	rh	interval from first verification to latest approval, using trans_type
M-RCF31	rdci	-
M-RCF31.1	rdci	ENTRY_COMPLETE_DT - ACTL_SUBJ_VIST_DT
M-RCF32	rdci	pass2_compltn_dt - pass1_compltn_dt
M-RCF33	rdci	for pCRFs in studies requiring pass 2 entry only. If pass 2 complete, then pass2_compltn_dt - pass1_compltn_dt; else LAST_ETL_DT - pass1_compltn_dt.
M-RCF34	rdci	ENTRY_COMPLETE_DT - ACTL_SUBJ_VIST_DT
M-RCF35	rh	for eCRFs only: Date of first verification that is not undone - PASS1_COMPLTN_DT
M-RCF36	rh	for eCRFs only: Date of first approval that is not undone - PASS1_COMPLTN_DT
M-RCF37	rdci	data_lock_ts - ENTRY_COMPLETE_DT
M-RCF38	rh	for eCRFs only: data_lock_ts - Date of latest approval
M-RCF39	rdci	for eCRFs only: pass1_compltn_dt - ACTL_SUBJ_VIST_DT
M-RCF40	rh	for eCRFs only: data_lock_dt - actl_subj_vist_dt
M-RCF41	rdci	avg(M-RCF39)
M-RCF42	rdci	avg(M-RCF31)
M-RCF43	rdci	avg(M-RCF32)
M-RCF44	rdci	avg(M-RCF33)
M-RCF45	rdci	avg(M-RCF34) for eCRFs
M-RCF45.1	rdci	avg(M-RCF34) for pCRFs
M-RCF46	rdci	avg(M-RCF35)
M-RCF47	rdci	avg(M-RCF36)
M-RCF48	rdci	M-RCF30/M-RCF71
M-RCF49	rdci	avg(M-RCF40)
M-RCF49.1	rdci	avg(M-RCF76)
M-RCF49.2	rdci	avg(M-RCF37)
M-RCF50	rdci	avg(M-RCF38)
M-RCF52	rdci	100 * M-RCF20/M-RCF75
M-RCF52.1	rdci	100 * M-RCF24/M-RCF75
M-RCF55.1	rdci	100 * M-RCF24/M-RCF01
M-RCF55.2	rdci	100 * M-RCF20/M-RCF01
M-RCF58	rdci	100 * M-RCF72 /M-RCF75
M-RCF62	rdci	100 * M-RCF29/M-RCF1
M-RCF62.1	rdci	100 * M-RCF72/M-RCF64.3
M-RCF62.2	rdci	100 * M-RCF74/M-RCF78
M-RCF63	rdci	100 * M-RCF22/M-RCF20
M-RCF64	rdci	100 * M-RCF26l/M-RCF24
M-RCF64.1	rdci	100 * M-RCF29/M-RCF75
M-RCF64.2	rdci	100 * (M-RCF74 + M-RCRF74.1)/M-RCF64.3
M-RCF64.3	rdci	100 * M-RCF71.1/M-RCF64.3
M-RCF64.4	rdci	100 * M-RCF74.1/M-RCF78
M-RCF65	rdci	100 * M-RCF1/M-RCF10
M-RCF68	rdci	count where eCRF and received_dci_status_code = 'PASS 1 COMPLETE'
M-RCF69	rdci	count where at least one non-undone verification has occurred.
M-RCF70	rdci	count where at least one non-undone approval has occurred.
M-RCF71.1	-	-
M-RCF72	rdci	count all DCIs received via RDC that are locked (data_lock_flag = 'Y') but not yet frozen (freeze_flag = 'N')
M-RCF73	rdci	pCRFs requiring pass 2 entry only: count where received_dci_status_code = 'PASS 1 COMPLETE'
M-RCF74	rdci	count all received paper DCIs that are locked (data_lock_flag = 'Y') but not yet frozen (freeze_flag = 'N')
M-RCF74.1	rdci	pCRFs only: count where TA-RCRF28 is 'Y'
M-RCF75	rdci	eCRFs only: count *
M-RCF76	rdci	For pCRFs:data_lock_ts - ENTRY_COMPLETE_DT
M-RCF77	rdci	Avg(Pass 1 complete dt - ACTL_SUBJ_VIST_DT)
M-RCF78	rdci	for pCRFs: count where ENTRY-COMPLETE
M-RCF81	rdci	eCRFs only: count where blank_flag = 'Y'
M-RCF82	rdci	pCRFs only: count where blank_flag = 'Y'
M-RCF83	rdci	-
M-RCF84	rdci	eCRFs only: count where subevent_number > 0
M-RCF85	rdci	pCRFs only: count where subevent_number > 0
M-RCF86	rdci	eCRFs only: count where received_dci_status_code = 'PASS 1 STARTED'
M-REG05	-	Not sourced from OC
M-REG07	-	Not sourced from OC
M-REG09	-	Not sourced from OC
M-REG10	-	Not sourced from OC
M-REG11	-	Not sourced from OC
M-REG12	-	Not sourced from OC
M-REG14	-	Not sourced from OC
M-REG15	-	Not sourced from OC
M-REG16	-	Not sourced from OC
M-REG17	-	Not sourced from OC
M-REG18	-	Not sourced from OC
M-REG19	-	Not sourced from OC
M-REG20	-	Not sourced from OC
M-SBVT03	-	Not sourced from OC
M-SBVT04	-	Not sourced from OC
M-SBVT05	-	Not sourced from OC
M-SBVT06	-	Not sourced from OC
M-SBVT07	-	Not sourced from OC
M-SBVT08	-	Not sourced from OC
M-SBVT09	-	Not sourced from OC
M-SBVT10	-	Not sourced from OC
M-SBVT11	-	Not sourced from OC
M-SBVT12	-	Not sourced from OC
M-SBVT13	-	Not sourced from OC
M-SBVT14	-	Not sourced from OC
M-SIV01	-	Not sourced from OC
M-SIV02	-	Not sourced from OC
M-SIV03	-	Not sourced from OC
M-SIV04	-	Not sourced from OC
M-SIV05	-	Not sourced from OC
M-SIV06	-	Not sourced from OC
M-SIV07	-	Not sourced from OC
M-SIV08	-	Not sourced from OC
M-SIV10	-	Not sourced from OC
M-SRG01	-	Not sourced from OC
M-SRG02	-	Not sourced from OC
M-SRG03	-	Not sourced from OC
M-SRG04	-	Not sourced from OC
M-SRG05	-	Not sourced from OC
M-SRG06	-	Not sourced from OC
M-SRG07	-	Not sourced from OC
M-SRG08	-	Not sourced from OC
M-SRG09	-	Not sourced from OC
M-SRG10	-	Not sourced from OC
M-SRG11	-	Not sourced from OC
M-SRG12	-	Not sourced from OC
M-SRG13	-	Not sourced from OC
M-SRG14	-	Not sourced from OC
M-SRG16	-	Not sourced from OC
M-SRG23	-	Not sourced from OC
M-SRG24	-	Not sourced from OC
M-SRG25	-	Not sourced from OC
M-SRG26	-	Not sourced from OC
M-SRG27	-	Not sourced from OC
M-SRG28	-	Not sourced from OC
M-SRG29	-	Not sourced from OC
M-SRG30	-	Not sourced from OC
M-SRG31	-	Not sourced from OC
M-SRG32	-	Not sourced from OC
M-SRG33	-	Not sourced from OC
M-SRG34	-	Not sourced from OC
M-SST01	ep.planned_patient_enrollment	-
M-SST02	pp	count(*) where .patient_enrollment_date is not null and screening_position_flag = 'N'
M-SST02C	-	-
M-SST03	pp	Calculate as # Subjects Enrolled - (# Early Terminations + # Subjects Lost to Follow up)
M-SST04	pp	Calculate as # Subjects Enrolled - (# Early Terminations + # Subjects Lost to Follow up + # Subjects Completed)
M-SST05	pp	A subject who has completed the study is one with an entry in patient_statuses with status of "COMPLETE"
M-SST05C	-	-
M-SST06	pp	An early terminator is one with an entry in patient_statuses with status of "EARLY TERM"
M-SST06C	-	-
M-SST08	ae	count actual events where sub-event number is 0.
M-SST09	ae	count actual events where sub-event number > 0.
M-SST15.1	-	100* (M-SST2/M-SST1)
M-SST17	-	M-DSC2/M-RCF10
M-SST18	-	M-DSC1/M-RCF10
M-SST19	-	M-DSC3/M-RCF10
M-SST20	-	M-DSC2/M-SST2
M-SST21	-	M-DSC1/M-SST2
M-SST23	-	M-DSC3/M-RCF10
M-SST24	-	M-DSC11/M-DSC2
M-SST24.1	-	(M-DSC11+M-DSC15)/(M-DSC2+M-DSC3)
M-SST24.2	-	min(min(M-DSC11), min(M-DSC15))
M-SST24.3	-	max(max(M-DSC11), max(M-DSC15))
M-SST27	-	min(M-DSC11)
M-SST28	-	max(M-DSC11)
M-SST29	-	M-DSC15/M-DSC3
M-SST30	-	min(M-DSC15)
M-SST31	-	max(M-DSC15)
M-SST32	-	Not sourced from OC
M-SST32C	-	Not sourced from OC
M-SST33	-	Not sourced from OC
M-SST33C	-	Not sourced from OC
M-SST34	-	Not sourced from OC
M-SST34C	-	Not sourced from OC
M-SST35	-	Not sourced from OC
M-SST35C	-	Not sourced from OC
M-SST36	-	Not sourced from OC
M-SST37	-	Not sourced from OC
M-SST38	-	Not sourced from OC
M-SST39	-	Not sourced from OC
M-SST40	-	Not sourced from OC
M-SST41	-	Not sourced from OC
M-SST42	-	Not sourced from OC
M-SST43	-	Not sourced from OC
M-SST44	-	Not sourced from OC
M-SST45	-	Not sourced from OC
M-SST46	-	Not sourced from OC
M-SST47	-	Not sourced from OC
M-SST48	-	Not sourced from OC
M-SST49	-	Not sourced from OC
M-SST50	-	Not sourced from OC
M-SST51	-	Not sourced from OC
M-SST52	-	Not sourced from OC
M-SST54	-	Not sourced from OC
M-SST55	-	Not sourced from OC
M-SST56	-	Not sourced from OC
M-SST57	-	Not sourced from OC
M-SST58	-	Not sourced from OC
M-SST59	-	Not sourced from OC
M-SST60	-	Not sourced from OC
M-SST61	-	Not sourced from OC
M-SST62	-	Not sourced from OC
M-SST63	-	Not sourced from OC
M-SST65	-	Not sourced from OC
M-SST66	-	Not sourced from OC
M-SST67	-	Not sourced from OC
M-SST68	-	Not sourced from OC
M-SST69	-	Not sourced from OC
M-SST70	-	Not sourced from OC
M-SST71	-	Not sourced from OC
M-SST72	-	Not sourced from OC
M-SST73	-	Not sourced from OC
M-SST74	-	Not sourced from OC
M-SST75	-	Not sourced from OC
M-SST76	-	Not sourced from OC
M-SST77	-	Not sourced from OC
M-SST78	-	Not sourced from OC
M-SST79	-	Not sourced from OC
M-SST80	-	Not sourced from OC
M-SST81	-	Not sourced from OC
M-SST82	-	Not sourced from OC
M-SST83	-	Not sourced from OC
M-SST84	-	Not sourced from OC
M-SST85	-	Not sourced from OC
M-SST86	-	Not sourced from OC
M-SST87	-	Not sourced from OC
M-SST88	-	Not sourced from OC
M-SST89	-	Not sourced from OC
M-SST90	-	Not sourced from OC
M-SST91	-	Not sourced from OC
M-SST92	-	Not sourced from OC
M-SST93	-	Not sourced from OC
M-SST94	-	Not sourced from OC
M-SST95	-	Not sourced from OC
M-SST96	-	Not sourced from OC
M-SST97	-	Not sourced from OC
M-SST98	-	Not sourced from OC
M-SST99	-	Not sourced from OC
M-SST100	-	Not sourced from OC
M-SST101	-	Not sourced from OC
M-SST102	-	Not sourced from OC
M-SST103	-	Not sourced from OC
M-SST104	-	Not sourced from OC
M-SST105	-	Not sourced from OC
M-SST106	-	Not sourced from OC
M-SST107	-	Not sourced from OC
M-STD01	ep	count (*) where plan_sub_type_code = 'SITE'
M-STD02	csv, ep	For a given study, first look at the number of patients to enroll in the live study version to determine planned enrollment for that study. If that is null, use study enrollment plan
M-STD06	-	100 * # Enrolled/# Enrollments Planned
M-STD07	-	Not sourced from OC
M-STD08	-	Not sourced from OC
M-STD09	-	Not sourced from OC
M-STD10	-	Not sourced from OC
M-STD11	-	Not sourced from OC
M-STD12	-	Not sourced from OC
M-STD13	-	Not sourced from OC
M-STD14	-	Not sourced from OC
M-STD15	-	Not sourced from OC
M-STD16	-	Not sourced from OC
M-STD17	-	Not sourced from OC
M-STD18	-	Not sourced from OC
M-STD20	-	Not sourced from OC
M-STD21	-	Not sourced from OC
M-STD22	-	Not sourced from OC
M-STD23	-	Not sourced from OC
M-STD24	-	Not sourced from OC
M-STD25	-	Not sourced from OC
M-STD26	-	Not sourced from OC
M-STD27	-	Not sourced from OC
M-STD28	-	Not sourced from OC
M-STD29	-	Not sourced from OC
M-STD30	-	Not sourced from OC
M-STD31	-	Not sourced from OC
M-STD32	-	Not sourced from OC
M-STD40	-	Not sourced from OC
M-STD42	-	Not sourced from OC
M-STD43	-	Not sourced from OC
M-STD44	-	Not sourced from OC
M-STD45	-	Not sourced from OC
M-STD46	-	Not sourced from OC
M-STD47	-	Not sourced from OC
M-STD48	-	Not sourced from OC
M-STD49	-	Not sourced from OC
M-STD50	-	Not sourced from OC
M-STD51	-	Not sourced from OC
M-STD52	-	Not sourced from OC
M-STD53	-	Not sourced from OC
M-STD54	-	Not sourced from OC
M-STD55	-	Not sourced from OC
M-STD56	-	Not sourced from OC
M-STD57	-	Not sourced from OC
M-STD58	-	Not sourced from OC
M-STD59	-	Not sourced from OC
M-STD60	-	Not sourced from OC
M-STD61	-	Not sourced from OC
M-STD62	-	Not sourced from OC
M-STD63	-	Not sourced from OC
M-STD64	-	Not sourced from OC
M-STD65	-	Not sourced from OC
M-STD66	-	Not sourced from OC
M-STD67	-	Not sourced from OC
M-STD68	-	Not sourced from OC
M-STD69	-	Not sourced from OC
M-STD70	-	Not sourced from OC
M-STD71	-	Not sourced from OC
M-STD72	-	Not sourced from OC
M-STD73	-	Not sourced from OC
M-STD74	-	Not sourced from OC
M-STD75	-	Not sourced from OC
M-STD76	-	Not sourced from OC
M-STD77	-	Not sourced from OC
M-STD78	-	Not sourced from OC
M-STD79	-	Not sourced from OC
M-STD80	-	Not sourced from OC
M-STD81	-	Not sourced from OC
M-STD82	-	Not sourced from OC
M-STD83	-	Not sourced from OC
M-STD84	-	Not sourced from OC
M-STD85	-	Not sourced from OC
M-STD86	-	Not sourced from OC
M-STD87	-	Not sourced from OC
M-STD88	-	Not sourced from OC
M-STD89	-	Not sourced from OC
M-STD90	-	Not sourced from OC
M-STD91	-	Not sourced from OC
M-STR01	-	Not sourced from OC
M-STR02	-	Not sourced from OC
M-STR03	-	Not sourced from OC
M-STR04	-	Not sourced from OC
M-STR05	-	Not sourced from OC
M-STR06	-	Not sourced from OC
M-STR07	-	Not sourced from OC
M-STR08	-	Not sourced from OC
M-STR09	-	Not sourced from OC
M-STR10	-	Not sourced from OC
M-STR11	-	Not sourced from OC
M-STR12	-	Not sourced from OC
M-STR13	-	Not sourced from OC
M-STR14	-	Not sourced from OC
M-STR15	-	Not sourced from OC
M-STR16	-	Not sourced from OC
M-STR17	-	Not sourced from OC
M-STR18	-	Not sourced from OC
M-STR19	-	Not sourced from OC
M-STR20	-	Not sourced from OC
M-STR21	-	Not sourced from OC
M-STR22	-	Not sourced from OC
M-STR23	-	Not sourced from OC
M-STR24	-	Not sourced from OC
M-STR25	-	Not sourced from OC
M-STR26	-	Not sourced from OC
M-STR27	-	Not sourced from OC
M-STR28	-	Not sourced from OC
M-STR29	-	Not sourced from OC
M-STR30	-	Not sourced from OC
M-STR31	-	Not sourced from OC
M-STR32	-	Not sourced from OC
M-STR33	-	Not sourced from OC
M-STR34	-	Not sourced from OC
M-STR35	-	Not sourced from OC
M-STR36	-	Not sourced from OC
M-STR37	-	Not sourced from OC
M-STR38	-	Not sourced from OC
M-TA01	-	Not sourced from OC
M-TA03	-	Not sourced from OC
M-TA05	-	Not sourced from OC
M-TA06	-	Not sourced from OC
M-TA07	-	Not sourced from OC
M-TA08	-	Not sourced from OC
M-TA09	-	Not sourced from OC
M-TA10	-	Not sourced from OC
M-TA11	-	Not sourced from OC
M-TA12	-	Not sourced from OC
M-TA13	-	Not sourced from OC
M-TA14	-	Not sourced from OC
M-TA15	-	Not sourced from OC
M-TA16	-	Not sourced from OC
M-TA20	-	Not sourced from OC
M-TA21	-	Not sourced from OC
M-TA22	-	Not sourced from OC
M-TA23	-	Not sourced from OC
M-TA24	-	Not sourced from OC
M-TA25	-	Not sourced from OC
M-TA26	-	Not sourced from OC
M-TA27	-	Not sourced from OC
TA-DISC01	disc.discrepancy_entry_id	-
TA-DISC02	cs.study	where cs.clinical_study_id = disc.clinical_study_id
TA-DISC03	os.name	where os.site_id = disc.site_id
TA-DISC04	inv	inv.last_name, inv.first_name where inv.investigator_id = disc.investigator_id
TA-DISC05	pp.patient	-
TA-DISC06	cpe.name	-
TA-DISC07	cpe.visit_number	-
TA-DISC08	disc.subevent_number	-
TA-DISC09	cpe.visit_number || '.' || disc.subevent_number where cpe.clin_plan_eve_id = disc.clin_plan_eve_id	-
TA-DISC10	rcdi.dci_date	-
TA-DISC11	rcdi.log_in_ts	-
TA-DISC12	dci.dci_id	-
TA-DISC13	disc.CRF_PAGE_NUMBER	-
TA-DISC14	dcm.name	-
TA-DISC15	dqg.name	-
TA-DISC16	dq.question_name	-
TA-DISC17	dq.occurrence_sn	-
TA-DISC19	disc.discrepancy_rev_status_code	where DISC_IRRESOLVABLE
TA-DISC20	proc.name	-
TA-DISC21	disc.DISCREPANCY_REV_STATUS_CODE	-
TA-DISC22	disc.discrepancy_rev_status_code	-
TA-DISC22.1	disc.discrepancy_rev_status_code	where STATE = 'CLOSED'
TA-DISC23	disc.DE_SUB_TYPE_CODE	-
TA-DISC24	discrepancy_entries.discrepancy_resolu_type_code	-
TA-DISC25	disc.creation_ts	-
TA-DISC26	disc	Date discrepancy STATE became CLOSED.
TA-DISC26.1	disc.DE_SUB_TYPE_CODE	Not sourced from OC
TA-DISC30	disc.comment_text	-
TA-DISC31	disc	Y' if disc.discrepancy_entry_id in (select discrepancy_id from dcf_discrepancies)
TA-DISC32	-	case disc.de_sub_type_code in ('MANUAL','MANUAL HEADER') then 'Non-System' else 'System' end origin
TA-DISC33	ss.study_site	where ss.SITE_ID = disc.site_id and ss.CLINICAL_STUDY_ID = disc.CLINICAL_STUDY_ID
TA-DOC01	-	Not sourced from OC
TA-DOC02	-	Not sourced from OC
TA-DOC03	-	Not sourced from OC
TA-DOC04	-	Not sourced from OC
TA-DOC05	-	Not sourced from OC
TA-DOC06	-	Not sourced from OC
TA-DOC07	-	Not sourced from OC
TA-DOC08	-	Not sourced from OC
TA-DOC09	-	Not sourced from OC
TA-FUI01	-	Not sourced from OC
TA-FUI02	-	Not sourced from OC
TA-FUI03	-	Not sourced from OC
TA-FUI04	-	Not sourced from OC
TA-FUI05	-	Not sourced from OC
TA-FUI06	-	Not sourced from OC
TA-FUI07	-	Not sourced from OC
TA-FUI08	-	Not sourced from OC
TA-RCRF01	rdci.document_id	-
TA-RCRF02	cs.study	where cs.clinical_study_id = rdci.clinical_study_id
TA-RCRF03	os.name	where os.site_id = rdci.site_id
TA-RCRF04	inv	first_name || ' ' || last_name
TA-RCRF05	pp.patient	-
TA-RCRF06	rdci.clin_plan_eve_name	-
TA-RCRF07	cpe.visit_number	-
TA-RCRF08	rdci.subevent_number	-
TA-RCRF09	rdci.visit_number, subevent_number	-
TA-RCRF10	rdci.dci_date	-
TA-RCRF11	rdci.dci_id	-
TA-RCRF12	book.name	-
TA-RCRF13	page.start_page_number	-
TA-RCRF14	rdci.received_dci_login_ts	-
TA-RCRF15	rdci.received_dci_status_code	-
TA-RCRF16	rdci.received_dci_id	case when rdcih.trans_type in 'SYS VER NO', 'SYS VER UNDONE') then 'Y' else 'N'
TA-RCRF17	rdci.received_dci_id	case when rdcih.trans_type ='SYS VER DATACHG' then 'Y' else 'N'
TA-RCRF19	rdci.received_dci_id	case when rdcih.trans_type in 'SYS APP NO', 'SYS APP UNDONE') then 'Y' else 'N'
TA-RCRF20	select rdci.received_dci_id,	case when rdcih.trans_type ='SYS APP DATACHG' then 'Y' else 'N'
TA-RCRF22	rdci.blank_flag	-
TA-RCRF23	rdci.data_lock_flag	-
TA-RCRF24	rdci	when rdci.received_dci_status_code in 'RECEIVED', 'PASS 1 STARTED') then 'Y' else 'N' end
TA-RCRF25	rdci	case when rdci.received_dci_status_code in 'PASS 1 COMPLETE', 'PASS 2 STARTED', 'PASS 2 PENDING') then 'Y' else 'N' end
TA-RCRF26	-	ENTRY_COMPLETE
TA-RCRF28	book.name	A received DCI is hard locked if the patient position for which that received DCI is collected has been frozen. Freezing the patient position means all of that patient position's received dcis are hard-locked. So we use pp.freeze_flag as hard-lock flag
TA-RCRF29	rdci.data_lock_ts	-
TA-RCRF30	rdci	Date of first non-undone verification, using rh.
TA-RCRF31	rdci.received_dci_status_code	Date of most recent non-undone verification, using rh.
TA-RCRF32	rdci	Date of first non-undone approval using rh.
TA-RCRF33	rdci	Date of most recent non-undone approval using rh.
TA-RCRF34	-	-
TA-RCRF35	-	see eCRF, pCRF
TA-SITE01	-	Not sourced from OC
TA-SIV01	-	Not sourced from OC
TA-SIV02	-	Not sourced from OC
TA-SIV03	-	Not sourced from OC
TA-SIV04	-	Not sourced from OC
TA-SIV05	-	Not sourced from OC
TA-SIV06	-	Not sourced from OC
TA-SIV07	-	Not sourced from OC
TA-SIV08	-	Not sourced from OC
TA-SIV09	-	Not sourced from OC
TA-SIV10	-	Not sourced from OC
TA-SIV11	-	Not sourced from OC
TA-SUBJ01	-	Not sourced from OC
TA-SUBJ02	-	Not sourced from OC
TA-SUBJ03	-	Not sourced from OC
TA-SUBJ04	-	Not sourced from OC
TA-SUBJ05	-	Not sourced from OC
TA-SUBJ06	-	Not sourced from OC
TA-SUBJ07	-	Not sourced from OC
TA-SUBJ08	-	Not sourced from OC
TA-SUBJ09	-	Not sourced from OC
TD01-01	pp.clinical_study_id	-
TD01-02	pp.patient	-
TD01-03	pp.dci_book_id	-
TD01-04	pp.freeze_flag	-
TD01-05	pp.early_termination_flag	-
TD01-06	ps, pp	icase when ps.patient_status_code ='ENROLLED' then ps.status_date when pp.patient_enrollment_date is not null then pp.patient_enrollment_date else null end
TD01-07	pp	Case when <TD01-06> is not null then 'Y' else 'N' end
TD01-08	pp.reported_initials	-
TD01-09	pp.reported_birth_date	-
TD01-10	pp.reported_death_date	-
TD01-11	ps	Use the latest status code for the subject
TD01-12	ps,pp	case when ps.patient_status_code ='COMPLETE' then ps.status_date when pp.termination_date is not null and pp.early_termination_flag != 'Y' then pp.termination_date else null end
TD01-16	pp.reported_sex	-
TD01-17	-	Not sourced from OC
TD01-18	-	Not sourced from OC
TD01-19	-	Not sourced from OC
TD01-20	-	Not sourced from OC
TD01-21	-	Not sourced from OC
TD01-22	-	Not sourced from OC
TD01-23	-	Not sourced from OC
TD01-24	-	Not sourced from OC
TD01-25	-	Not sourced from OC
TD01-26	-	Not sourced from OC
TD01-27	-	Not sourced from OC
TD01-28	-	Not sourced from OC
TD01-29	-	Not sourced from OC
TD01-30	-	Not sourced from OC
AD09-75	S_CL_PTCL_LS.OBJECTIVE_DESC	Not sourced from OC
AD09-76	S_ASSESS. ASSESS_TMPL_NAME	Not sourced from OC
AD09-77	S_ASSESS. LAST_UPD	Not sourced from OC
AD09-78	S_ASSESS. NAME	Not sourced from OC
AD09-79	S_ASSESS.DESC_TEXT	Not sourced from OC
AD09-81	-	Not sourced from OC
AD09-82	-	Not sourced from OC
AD09-83	-	Not sourced from OC
AD09-84	-	Not sourced from OC
AD09-85	-	Not sourced from OC
AD09-86	-	Not sourced from OC
AD09-87	-	Not sourced from OC
AD09-88	-	Not sourced from OC
AD10-78	S_PTCL_SITE_LS. MAX_ENROLLMENT	Not sourced from OC
AD10-79	S_ASSESS. ASSESS_TMPL_NAME	Not sourced from OC
AD10-80	S_ASSESS. LAST_UPD	Not sourced from OC
AD10-81	S_ASSESS. NAME	Not sourced from OC
AD10-82	S_PTCL_SITE_LS. SDV_TYPE_CD	Not sourced from OC
AD10-82	S_PTCL_SITE_LS. SDV_TYPE_CD	Not sourced from OC
AD16-17	S_ASSESS. ASSESS_TMPL_NAME	Not sourced from OC
AD16-18	S_ASSESS. LAST_UPD	Not sourced from OC
AD16-19	S_ASSESS. NAME	Not sourced from OC
AD16-20	S_ASSESS.DESC_TEXT	Not sourced from OC
AD16-21	S_ASSESS. SCORE	Not sourced from OC
AD17-48	S_ASSESS. ASSESS_TMPL_NAME	Not sourced from OC
AD17-49	S_ASSESS. LAST_UPD	Not sourced from OC
AD17-50	S_ASSESS. NAME	Not sourced from OC
AD17-51	S_ASSESS.DESC_TEXT	Not sourced from OC
AD18-13	-	Not sourced from OC
AD18-14	-	Not sourced from OC
AD18-15	-	Not sourced from OC
AD18-16	-	Not sourced from OC
AD18-17	-	Not sourced from OC
AD18-18	-	Not sourced from OC
AD18-19	-	Not sourced from OC
AD18-20	-	Not sourced from OC
AD18-21	-	Not sourced from OC
AD18-22	-	Not sourced from OC
AD23-01	-	Not sourced from OC
AD23-02	-	Not sourced from OC
AD23-03	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from OC Note: This column is a concatenation of Category + : + Question. For this measure source only the substring before the first ": " If field does not have a ":" or begins with a ":", then use the category "No Category".
AD23-04	-	Not sourced from OC
AD23-05	-	Not sourced from OC
AD23-07	-	Not sourced from OC
M-PRR01	-	Not sourced from OC
M-PRR02	-	Not sourced from OC
M-PRR03	-	Not sourced from OC
M-PRR04	S_ASSESS_VAL .SCORE	Not sourced from OC
M-PRR05	S_ASSESS_VAL .COMMENTS	Not sourced from OC
M-PRR06	S_ASSESS_VAL .SEQUENCE_NUM	Not sourced from OC
M-PRR07	-	Not sourced from OC
M-PRR08	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from OC
M-PRR09	-	Not sourced from OC
M-PRR10	Impact (M-PRR04)	Not sourced from OC
M-PRR11	S_ASSESS_VAL . WEIGHT	Not sourced from OC
M-PRR12	Avg of child question scores	Not sourced from OC
M-PTL01	S_PTCL_VER_LS. AMND_VERSION	Not sourced from OC
M-PTL02	S_PTCL_VER_LS. VER_CREATED_DT	Not sourced from OC
M-PTL03	S_PTCL_VER_LS. ORIG_VER_FLG	Not sourced from OC
M-PTL04	-	Not sourced from OC
M-PTL05	-	Not sourced from OC
M-PTL06	S_PTCL_VER_LS. COMMENTS	Not sourced from OC
M-SDR01	-	Not sourced from OC
M-SDR02	-	Not sourced from OC
M-SDR03	-	Not sourced from OC
M-SDR04	S_ASSESS_VAL . SCORE	Not sourced from OC
M-SDR05	S_ASSESS_VAL .COMMENTS	Not sourced from OC
M-SDR06	S_ASSESS_VAL .SEQUENCE_NUM	Not sourced from OC
M-SDR07	-	Not sourced from OC
M-SDR08	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from OC
M-SDR09	-	Not sourced from OC
M-SDR10	Impact (M-SDR04)	Not sourced from OC
M-SDR11	S_ASSESS_VAL . WEIGHT	Not sourced from OC
M-SDR12	Avg of child question scores	Not sourced from OC
M-SRG36	S_CL_PTCL_LS.INIT_NUM_OF_SUBJ	Not sourced from OC
M-SRG37	S_CL_PTCL_LS. SEL_CL_SUBJ_PCT	Not sourced from OC
M-SRR01	-	Not sourced from OC
M-SRR02	-	Not sourced from OC
M-SRR03	-	Not sourced from OC
M-SRR04	S_ASSESS_VAL . SCORE	Not sourced from OC
M-SRR05	S_ASSESS_VAL .COMMENTS	Not sourced from OC
M-SRR06	S_ASSESS_VAL .SEQUENCE_NUM	Not sourced from OC
M-SRR07	-	Not sourced from OC
M-SRR08	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from OC
M-SRR09	-	Not sourced from OC
M-SRR10	Impact (M-SRR04)	Not sourced from OC
M-SRR11	S_ASSESS_VAL . WEIGHT	Not sourced from OC
M-SRR12	Avg of child question scores	Not sourced from OC
M-SSR01	-	Not sourced from OC
M-SSR02	-	Not sourced from OC
M-SSR03	-	Not sourced from OC
M-SSR04	S_ASSESS_VAL . SCORE	Not sourced from OC
M-SSR05	S_ASSESS_VAL .COMMENTS	Not sourced from OC
M-SSR06	S_ASSESS_VAL .SEQUENCE_NUM	Not sourced from OC
M-SSR07	-	Not sourced from OC
M-SSR08	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from OC
M-SSR09	-	Not sourced from OC
M-SSR10	Impact (M-SSR04)	Not sourced from OC
M-SSR11	S_ASSESS_VAL . WEIGHT	Not sourced from OC
M-SSR12	Avg of child question scores	Not sourced from OC
M-SST107	S_PTCL_SITE_LS.INIT_NUM_OF_SUBJ	Not sourced from OC
M-SST108	S_PTCL_SITE_LS. SEL_CL_SUBJ_PCT	Not sourced from OC
M-STD100	-	Not sourced from OC
M-STD101	-	Not sourced from OC
M-STD102	-	Not sourced from OC
M-STD103	-	Not sourced from OC
M-STD104	-	Not sourced from OC
M-STD105	-	Not sourced from OC
M-STD106	-	Not sourced from OC
M-STD107	-	Not sourced from OC
M-STD108	-	Not sourced from OC
M-STD109	-	Not sourced from OC
M-STD110	-	Not sourced from OC
M-STD111	-	Not sourced from OC
M-STD112	-	Not sourced from OC
M-STD113	-	Not sourced from OC
M-STD114	-	Not sourced from OC Count of all versions of a protocol that are not the original version that have been flagged as avoidable.
M-STD115	S_CL_PTCL_LS.INIT_NUM_OF_SUBJ	Not sourced from OC
M-STD116	S_CL_PTCL_LS.SEL_CL_SUBJ_PCT	Not sourced from OC
M-STD93	-	Not sourced from OC
M-STD94	-	Not sourced from OC
M-STD95	-	Not sourced from OC
M-STD96	-	Not sourced from OC
M-STD97	-	Not sourced from OC
M-STD98	-	Not sourced from OC
M-STD99	-	Not sourced from OC
TA-SIV12	S_EVT_ACT_LSX. REVIEWED_TS	Not sourced from OC
TA-SIV13	S_EVT_ACT_LSX. REVIEW_COMMENTS	Not sourced from OC
TA-SIV14	Employee Last, First Name; Join on S_EVT_ACT_LSX. REVIEWER_ID	Not sourced from OC
TA-SIV15	Employee Last, First Name; Join on S_EVT_ACT_LSX. APPROVER_ID	Not sourced from OC
TA-SUBJ10	S_CL_SUBJ_LS.	Not sourced from OC
TA-SUBJ11	S_CL_SUBJ_LS .SDV_UPD_TYPE_CD	Not sourced from OC

Aliases

To display the information compactly, Table B-3 uses aliases for table names. Table B-4 lists these aliases:

Table B-4 Aliases for Table Names

Alias	Table Name
book	rxc.dci_books
cpe	rxa_des.clinical_planned_events
cs	rxa_des.clinical_studies
dci	rxc.dcis
derh	rxc.discrepancy_review_hist
disc	rxc.discrepancy_entries
dq	rxc.dcm_questions
dqg	rxc.dcm_question_groups
ep	rxa_des.enrollment_plans
inv	rxa_des.ocl_investigators
os	rxa_des.ocl_studies
page	rxc.dci_book_pages
pp	rxa_des.patient_positions
pm	rxa_des.ocl_product_masters
proc	rxc.procedures
ps	rxa_des.patient_statuses
rcv	rxc.reference_codelist_values
rdci	rxc.received_dcis
rdcm	rxc.received_dcms
site	rxa_des.ocl_sites
ss	rxa_des.ocl_study_sites

Caution:

Where source location is described in snippets of SQL code, it should be read as an indication of how the information is to be extracted. This is typically not the actual code used in the OC-specific ETL programs. Consult the ETL for actual extraction queries.

Note that:

• eCRF is distinguished from pCRF by the first character in the document ID. If this is 'R', the document is assumed to be entered through RDC, and therefore an eCRF. Otherwise, it is considered to be an eCRF.

• ACTL_SUBJ_VIST_DT is the date when the RDCI was collected. This is taken to be the first non-null of these: rdci.visit_date; min(rdcm.visit_date) for the rdci; min(rdci.visit_date) for the rdci's visit; min(rdcm.visit_date) for the rdci's visit.

• ENTRY_COMPLETE: an eCRF is entry complete if it is pass 1 complete; a pCRF is entry complete if either (a) pass 2 is required and it is pass 2 complete, or (b) it is pass 1 complete.

• ENTRY_COMPLETE_DT is the date when RDCI became ENTRY_COMPLETE.

• LAST_ETL_DT is the date when the ETL was last executed.

• All queries on received_dcis look only at records where end_ts = to_date(3000000, 'J')

• A discrepancy is DISC_IRRESOLVABLE if disc.discrepancy_rev_status_code in (select rcv.ref_codelist_value_short_val from reference_codelist_values rcv where rcv.ref_codelist_name = 'DISCREPANCY REV STATUS CODE' and rcv.long_value = 'IRRESOLVABLE');

• A discrepancy's STATE is CLOSED {DISCREPANCY_REV_STATUS_CODE is 'CLOSED', or DISCREPANCY_STATUS_CODE = 'OBSOLETE', or DISC_IRRESOLVABLE). OPEN otherwise.

Oracle's Siebel Clinical Sources for OHSCDA Presentation Catalog

Table B-5 describes how OHSCDA populates each column from an Siebel Clinical (SC) database. Each Measure has an ID number, which is provided for cross-reference to other tables in this Appendix.

Table B-5 Presentation Catalog - Siebel Clinical Sources

Attribute ID	Source Table/Column	Comments/Details
AD02-02	-	Not sourced from SC
AD02-03	-	Not sourced from SC
AD02-04	-	Not sourced from SC
AD02-05	-	Not sourced from SC
AD02-06	-	Not sourced from SC
AD02-07	-	Not sourced from SC
AD02-08	-	Not sourced from SC
AD02-09	-	Not sourced from SC
AD02-10	-	Not sourced from SC
AD02-11	-	Not sourced from SC
AD02-12	-	Not sourced from SC
AD02-13	-	Not sourced from SC
AD02-14	-	Not sourced from SC
AD02-15	-	Not sourced from SC
AD02-16	-	Not sourced from SC
AD02-17	-	Not sourced from SC
AD02-18	-	Not sourced from SC
AD02-19	-	Not sourced from SC
AD02-20	-	Not sourced from SC
AD02-21	-	Not sourced from SC
AD02-22	-	Not sourced from SC
AD02-23	-	Not sourced from SC
AD02-24	-	Not sourced from SC
AD02-25	-	Not sourced from SC
AD02-26	-	Not sourced from SC
AD02-27	-	Not sourced from SC
AD02-28	-	Not sourced from SC
AD02-29	-	Not sourced from SC
AD02-30	-	Not sourced from SC
AD02-31	-	Not sourced from SC
AD02-32	-	Not sourced from SC
AD02-33	-	Not sourced from SC
AD02-34	-	Not sourced from SC
AD02-35	-	Not sourced from SC
AD02-36	-	Not sourced from SC
AD02-37	-	Not sourced from SC
AD02-38	-	Not sourced from SC
AD02-39	-	Not sourced from SC
AD02-40	-	Not sourced from SC
AD02-41	-	Not sourced from SC
AD02-42	-	Not sourced from SC
AD02-43	-	Not sourced from SC
AD02-44	-	Not sourced from SC
AD02-45	-	Not sourced from SC
AD02-46	-	Not sourced from SC
AD02-47	-	Not sourced from SC
AD02-48	-	Not sourced from SC
AD02-49	-	Not sourced from SC
AD02-50	-	Not sourced from SC
AD02-51	-	Not sourced from SC
AD02-52	-	Not sourced from SC
AD02-53	-	Not sourced from SC
AD02-54	-	Not sourced from SC
AD02-55	-	Not sourced from SC
AD02-56	-	Not sourced from SC
AD02-57	-	Not sourced from SC
AD02-58	-	Not sourced from SC
AD02-59	-	Not sourced from SC
AD02-60	-	Not sourced from SC
AD02-61	-	Not sourced from SC
AD02-62	-	Not sourced from SC
AD02-63	-	Not sourced from SC
AD02-64	-	Not sourced from SC
AD02-65	-	Not sourced from SC
AD02-66	-	Not sourced from SC
AD02-67	-	Not sourced from SC
AD02-68	-	Not sourced from SC
AD02-69	-	Not sourced from SC
AD02-70	-	Not sourced from SC
AD02-71	-	Not sourced from SC
AD02-72	-	Not sourced from SC
AD02-73	-	Not sourced from SC
AD02-74	-	Not sourced from SC
AD02-75	-	Not sourced from SC
AD02-76	-	Not sourced from SC
AD02-77	-	Not sourced from SC
AD02-78	-	Not sourced from SC
AD02-79	-	Not sourced from SC
AD02-80	-	Not sourced from SC
AD02-81	-	Not sourced from SC
AD02-82	-	Not sourced from SC
AD02-83	-	Not sourced from SC
AD02-84	-	Not sourced from SC
AD02-85	-	Not sourced from SC
AD02-86	-	Not sourced from SC
AD02-87	-	Not sourced from SC
AD02-88	-	Not sourced from SC
AD02-89	-	Not sourced from SC
AD02-90	-	Not sourced from SC
AD02-91	-	Not sourced from SC
AD02-92	-	Not sourced from SC
AD02-93	-	Not sourced from SC
AD02-94	-	Not sourced from SC
AD02-95	-	Not sourced from SC
AD02-96	-	Not sourced from SC
AD02-97	-	Not sourced from SC
AD02-98	-	Not sourced from SC
AD02-99	-	Not sourced from SC
AD02-100	-	Not sourced from SC
AD02-101	-	Not sourced from SC
AD02-102	-	Not sourced from SC
AD02-103	-	Not sourced from SC
AD02-104	-	Not sourced from SC
AD02-105	-	Not sourced from SC
AD02-106	-	Not sourced from SC
AD02-107	-	Not sourced from SC
AD02-108	-	Not sourced from SC
AD02-109	-	Not sourced from SC
AD02-110	-	Not sourced from SC
AD02-111	-	Not sourced from SC
AD02-112	-	Not sourced from SC
AD02-113	-	Not sourced from SC
AD02-114	-	Not sourced from SC
AD02-115	-	Not sourced from SC
AD02-116	-	Not sourced from SC
AD02-117	-	Not sourced from SC
AD02-118	-	Not sourced from SC
AD02-119	-	Not sourced from SC
AD02-120	-	Not sourced from SC
AD02-121	-	Not sourced from SC
AD02-122	-	Not sourced from SC
AD02-123	-	Not sourced from SC
AD02-124	-	Not sourced from SC
AD02-125	-	Not sourced from SC
AD02-126	-	Not sourced from SC
AD02-127	-	Not sourced from SC
AD02-128	-	Not sourced from SC
AD02-129	-	Not sourced from SC
AD02-130	-	Not sourced from SC
AD02-131	-	Not sourced from SC
AD02-132	-	Not sourced from SC
AD02-133	-	Not sourced from SC
AD02-134	-	Not sourced from SC
AD02-135	-	Not sourced from SC
AD02-136	-	Not sourced from SC
AD02-137	-	Not sourced from SC
AD02-138	-	Not sourced from SC
AD02-139	-	Not sourced from SC
AD02-140	-	Not sourced from SC
AD02-141	-	Not sourced from SC
AD02-142	-	Not sourced from SC
AD02-143	-	Not sourced from SC
AD02-144	-	Not sourced from SC
AD02-145	-	Not sourced from SC
AD02-146	-	Not sourced from SC
AD02-147	-	Not sourced from SC
AD02-148	-	Not sourced from SC
AD02-149	-	Not sourced from SC
AD02-150	-	Not sourced from SC
AD02-151	-	Not sourced from SC
AD02-152	-	Not sourced from SC
AD02-153	-	Not sourced from SC
AD02-154	-	Not sourced from SC
AD02-155	-	Not sourced from SC
AD02-156	-	Not sourced from SC
AD02-157	-	Not sourced from SC
AD04-01	-	Not sourced from SC
AD04-03	-	Not sourced from SC
AD04-04	-	Not sourced from SC
AD04-05	-	Not sourced from SC
AD04-06	-	Not sourced from SC
AD04-07	-	Not sourced from SC
AD05-01	S_CONTACT.LAST_NAME	-
AD05-02	S_CONTACT.FST_NAME	-
AD05-03	S_CONTACT.LAST_NAME + S_CONTACT.FST_NAME	-
AD05-04	S_ADDR_PER.ADDR	-
AD05-05	S_ADDR_PER.CITY	-
AD05-06	S_ADDR_PER.ZIPCODE	-
AD05-07	S_ADDR_PER.STATE	-
AD05-08	S_ADDR_PER.COUNTRY	-
AD05-09	-	Not sourced from SC
AD05-10	S_CONTACT.WORK_PH_NUM	-
AD05-11	-	Not sourced from SC
AD05-12	S_CONTACT.CELL_PH_NUM	-
AD05-13	S_CONTACT.EMAIL_ADDR	-
AD05-14	S_CONTACT.FAX_PH_NUM	-
AD05-15	S_CONTACT.MID_NAME	-
AD05-16	S_CONTACT.CON_CD	-
AD05-17	S_ADDR_PER.ADDR_LINE_2	-
AD05-18	S_ADDR_PER.ADDR_LINE_3	-
AD05-19	S_CONTACT_ROW_ID	-
AD07-01	S_PROD_INT.NAME	-
AD07-02	S_PROD_INT.TYPE	-
AD07-03	-	Not sourced from SC
AD07-04	S_PROD_INT.DESC_TEXT	-
AD07-07	S_PROD_INT.PART_NUM	-
AD07-08	S_PROD_INT.STATUS_CD	-
AD07-09	S_PROD_INT.ROW_ID	-
AD08-01	S_ORG_EXT.NAME	-
AD08-02	S_ADDR_PER.STATE	S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID
AD08-03	S_ADDR_PER.COUNTRY	S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID
AD08-04	-	Not sourced from SC
AD08-05	S_BU.NAME	S_ORG_EXT.BU_ID = S_BU.PAR_ROW_ID
AD08-06	S_ORG_EXT.ID	-
AD08-07	S_ADDR_PER.ADDR	S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID
AD08-08	S_ADDR_PER.ADDR_LINE_2	S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID
AD08-09	S_ADDR_PER.ADDR_LINE_3	S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID
AD08-10	S_ADDR_PER.ZIPCODE	S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID
AD08-11	S_ADDR_PER.COUNTY	S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID
AD08-12	S_ADDR_PER.CITY	S_ORG_EXT.PR_ADDR_ID = S_ADDR_PER.ROW_ID
AD09-01	S_CL_PTCL_LS.PTCL_NUM	-
AD09-02	S_CL_PTCL_LS.PTCL_ABBR_TL	-
AD09-03	S_CL_PGM_LS.NAME	-
AD09-04	-	Not sourced from SC
AD09-05	-	Not sourced from SC
AD09-06	-	Not sourced from SC
AD09-07	S_CL_PTCL_LS.PTCL_COMP_AGNT	-
AD09-08	S_CL_PTCL_LS.PTCL_DIAGNOSIS	-
AD09-09	S_CL_PTCL_LS.EUDRA_NUM	-
AD09-10	S_CL_PTCL_LS.PTCL_PHASE	-
AD09-11	S_CL_PTCL_LS.PTCL_STAT_CD	-
AD09-12	S_CL_PTCL_LS.PTCL_TITLE	-
AD09-13	S_CL_PTCL_LS.PTCL_TYPE_CD	-
AD09-14	S_CL_PTCL_LS.DB_LOCK_DT	-
AD09-15	S_CL_PTCL_LS.ROW_ID	-
AD09-16	S_CONTACT.S_CONTACT.LAST_NAME & ', ' & S_CONTACT.FST_NAME	where S_PT_POS_HST_LS.ROLE_CD = "Study Manager'
AD09-17	S_PROD_INT.NAME	-
AD09-18	-	Not sourced from SC
AD09-19	-	Not sourced from SC
AD09-20	-	Not sourced from SC
AD09-22	-	Not sourced from SC
AD09-23	-	Not sourced from SC
AD09-24	-	Not sourced from SC
AD09-25	-	Not sourced from SC
AD09-26	-	Not sourced from SC
AD09-27	-	Not sourced from SC
AD09-28	-	Not sourced from SC
AD09-29	-	Not sourced from SC
AD09-30	-	Not sourced from SC
AD09-31	-	Not sourced from SC
AD09-32	-	Not sourced from SC
AD09-33	-	Not sourced from SC
AD09-34	-	Not sourced from SC
AD09-35	-	Not sourced from SC
AD09-36	-	Not sourced from SC
AD09-38	-	Not sourced from SC
AD09-39	-	Not sourced from SC
AD09-40	-	Not sourced from SC
AD09-41	-	Not sourced from SC
AD09-42	-	Not sourced from SC
AD09-43	-	Not sourced from SC
AD09-44	-	Not sourced from SC
AD09-45	-	Not sourced from SC
AD09-46	-	Not sourced from SC
AD09-47	-	Not sourced from SC
AD09-48	-	Not sourced from SC
AD09-49	-	Not sourced from SC
AD09-50	-	Not sourced from SC
AD09-51	-	Not sourced from SC
AD09-52	-	Not sourced from SC
AD09-53	-	Not sourced from SC
AD09-54	-	Not sourced from SC
AD09-55	-	Not sourced from SC
AD09-56	-	Not sourced from SC
AD09-57	-	Not sourced from SC
AD09-58	-	Not sourced from SC
AD09-59	-	Not sourced from SC
AD09-60	-	Not sourced from SC
AD09-61	-	Not sourced from SC
AD09-62	-	Not sourced from SC
AD09-63	-	Not sourced from SC
AD09-64	-	Not sourced from SC
AD09-65	-	Not sourced from SC
AD09-66	-	Not sourced from SC
AD09-67	-	Not sourced from SC
AD09-68	-	Not sourced from SC
AD09-69	-	Not sourced from SC
AD09-70	-	Not sourced from SC
AD09-71	-	Not sourced from SC
AD09-72	-	Not sourced from SC
AD09-73	-	Not sourced from SC
AD09-74	-	Not sourced from SC
AD10-01	S_ORG_EXT.NAME	-
AD10-02	S_PTCL_SITE_LS.SITE_NUM	-
AD10-03	S_CL_PTCL_LS.REGION_CD	-
AD10-04	S_CL_PTCL_LS.PTCL_NUM	-
AD10-05	S_CL_PGM_LS.NAME	-
AD10-06	-	Not sourced from SC
AD10-07	-	Not sourced from SC
AD10-08	-	Not sourced from SC
AD10-10	S_PTCL_SITE_LS.FST_SUBJ_ENRL_DT	-
AD10-22	S_CONTACT.LAST_NAME+FST_NAME	S_PTL_ST_CON_LS.AFFL_CON_ID=S_CONTACT.PAR_ROW_ID AND RELATION_TYPE_CD ='Principal Investigator'
AD10-24	S_ORG_EXT.NAME	-
AD10-25	-	Not sourced from SC
AD10-26	-	Not sourced from SC
AD10-29	S_PTCL_SITE_LS.STATUS_CD	-
AD10-31	-	Not sourced from SC
AD10-32	S_ADDR_PER.CITY	-
AD10-33	S_ADDR_PER.ZIPCODE	-
AD10-34	S_ADDR_PER.ADDR	-
AD10-35	S_ADDR_PER.ADDR_LINE_2	-
AD10-36	S_ADDR_PER.ADDR_LINE_3	-
AD10-37	-	In Business Model only - concatenation of Study #, Site #, P Investigator Last Name
AD10-38	S_CL_PTCL_LS.PTCL_STAT_CD	REGION_CD NOT NULL
AD10-39	S_PTCL_SITE_LS.ROW_ID	-
AD10-40	S_CL_PTCL_LS.PTCL_STAT_CD	-
AD10-41	S_PTCL_SITE_LS.ST_INITN_CMPL_DT	-
AD10-42	S_CONTACT.S_CONTACT.LAST_NAME & ', ' & S_CONTACT.FST_NAME	where S_ST_POS_HST_LS.ROLE_CD = "CRA"
AD10-43	S_PROD_INT.NAME	-
AD10-44	S_ADDR_PER.COUNTRY	-
AD10-45	S_ADDR_PER.STATE	-
AD10-46	-	Not sourced from SC
AD10-47	-	Not sourced from SC
AD10-48	-	Not sourced from SC
AD10-49	-	Not sourced from SC
AD10-50	-	Not sourced from SC
AD10-51	-	Not sourced from SC
AD10-52	-	Not sourced from SC
AD10-53	-	Not sourced from SC
AD10-54	-	Not sourced from SC
AD10-55	-	Not sourced from SC
AD10-56	-	Not sourced from SC
AD10-57	-	Not sourced from SC
AD10-58	-	Not sourced from SC
AD10-59	-	Not sourced from SC
AD10-60	-	Not sourced from SC
AD10-61	-	Not sourced from SC
AD10-62	-	Not sourced from SC
AD10-63	-	Not sourced from SC
AD10-64	-	Not sourced from SC
AD10-65	-	Not sourced from SC
AD10-66	-	Not sourced from SC
AD10-67	-	Not sourced from SC
AD10-68	-	Not sourced from SC
AD10-69	-	Not sourced from SC
AD10-70	-	Not sourced from SC
AD10-71	-	Not sourced from SC
AD10-72	-	Not sourced from SC
AD10-73	-	Not sourced from SC
AD10-74	S_PTCL_SITE_LS.SITE_TERM_DT	-
AD10-75	-	Not sourced from SC
AD10-76	S_ADDR_PER.LATITUDE	-
AD10-77	S_ADDR_PER.LONGITUDE	-
AD11-01	-	Not sourced from SC
AD11-02	-	Not sourced from SC
AD11-03	-	Not sourced from SC
AD11-04	-	Not sourced from SC
AD11-05	-	Not sourced from SC
AD12-01	-	Not sourced from SC
AD12-02	-	Not sourced from SC
AD13-01	-	Not sourced from SC
AD13-02	-	Not sourced from SC
AD13-03	-	Not sourced from SC
AD13-04	-	Not sourced from SC
AD14-01	S_CONTACT.FST_NAME	-
AD14-02	S_CONTACT.LAST_NAME	-
AD14-03	S_CONTACT.FULL_NAME	-
AD14-04	S_ST_HST_POS_LS.ROLE_CD	-
AD14-05	S_ST_HST_POS_LS.START_DT	-
AD14-06	S_ST_HST_POS_LS.END_DT	-
AD14-07	S_ST_HST_POS_LS.COMMENTS	-
AD14-08	S_CONTACT.ROW_ID	-
AD14-09	-	S_ST_HST_POS_LS.END_DT is null or > today
AD14-10	S_CONTACT.EMAIL_ADDR	-
AD15-01	S_ADDR_PER.CITY	-
AD15-02	S_ADDR_PER.COUNTRY	-
AD15-03	-	Not sourced from SC
AD15-04	S_CONTACT.EMAIL_ADDR	-
AD15-05	S_CONTACT.EMP_FLG	-
AD15-06	S_CONTACT.FAX_PH_NUM	-
AD15-07	S_CONTACT.FST_NAME	-
AD15-08	S_CONTACT.FULL_NAME	-
AD15-09	S_CONTACT.LAST_NAME	-
AD15-10	S_CONTACT.MID_NAME	-
AD15-11	S_CONTACT.CELL_PH_NUM	-
AD15-12	S_CONTACT.WORK_PHONE	-
AD15-13	S_ADDR_PER.ZIPCODE	-
AD15-15	S_ADDR_PER.STATE	-
AD15-16	S_ADDR_PER.ST_ADDRESS	-
AD15-17	S_ADDR_PER.ADDR_LINE_2	-
AD15-18	S_ADDR_PER.ADDR_LINE_3	-
AD15-19	S_CONTACT_ROW_ID	-
AD16-01	S_CL_PGM_LS.DESC_TEXT	-
AD16-02	S_CL_PGM_LS.NAME	-
AD16-03	S_CL_PGM_LS.PROG_MCHNSM_CD	-
AD16-04	S_CL_PGM_LS.ROW_ID	-
AD16-05	-	Not sourced from SC
AD16-06	-	Not sourced from SC
AD16-07	-	Not sourced from SC
AD16-08	-	Not sourced from SC
AD16-09	-	Not sourced from SC
AD16-10	-	Not sourced from SC
AD16-11	-	Not sourced from SC
AD16-12	-	Not sourced from SC
AD16-13	-	Not sourced from SC
AD16-14	-	Not sourced from SC
AD16-15	-	Not sourced from SC
AD16-16	-	Not sourced from SC
AD17-01	S_CL_PTCL_LS.REGION_CD	-
AD17-02	S_CL_PTCL_LS.PTCL_STAT_CD	REGION_CD NOT NULL
AD17-03	S_ORG_EXT.NAME	-
AD17-04	S_CL_PTCL_LS_ROW_ID	-
AD17-05	-	Not sourced from SC
AD17-06	-	Not sourced from SC
AD17-07	-	Not sourced from SC
AD17-08	-	Not sourced from SC
AD17-09	-	Not sourced from SC
AD17-10	-	Not sourced from SC
AD17-11	-	Not sourced from SC
AD17-12	-	Not sourced from SC
AD17-13	-	Not sourced from SC
AD17-14	-	Not sourced from SC
AD17-15	-	Not sourced from SC
AD17-16	-	Not sourced from SC
AD17-17	S_CONTACT	LAST_NAME, FST_NAME where S_PT_POS_HST_LS.ROLE_CD = "Region Manager'
AD17-18	-	Not sourced from SC
AD17-19	-	Not sourced from SC
AD17-20	-	Not sourced from SC
AD17-21	-	Not sourced from SC
AD17-22	-	Not sourced from SC
AD17-23	-	Not sourced from SC
AD17-24	-	Not sourced from SC
AD17-25	-	Not sourced from SC
AD17-26	-	Not sourced from SC
AD17-27	-	Not sourced from SC
AD17-28	-	Not sourced from SC
AD17-29	-	Not sourced from SC
AD17-30	-	Not sourced from SC
AD17-31	-	Not sourced from SC
AD17-32	-	Not sourced from SC
AD17-33	-	Not sourced from SC
AD17-34	-	Not sourced from SC
AD17-35	-	Not sourced from SC
AD17-36	-	Not sourced from SC
AD17-37	-	Not sourced from SC
AD17-38	-	Not sourced from SC
AD17-39	-	Not sourced from SC
AD17-40	-	Not sourced from SC
AD17-41	-	Not sourced from SC
AD17-42	-	Not sourced from SC
AD17-43	S_CL_PTCL_LS	REGION_CD
AD17-44	S_CL_PTCL_LS	PTCL_NUM+ "/ " + REGION_CD
AD17-45	-	Not sourced from SC
AD17-46	-	Not sourced from SC
AD17-47	-	Not sourced from SC
AD18-01	-	Not sourced from SC
AD18-02	-	Not sourced from SC
AD18-03	-	Not sourced from SC
AD18-04	-	Not sourced from SC
AD18-05	-	Not sourced from SC
AD18-06	-	Not sourced from SC
AD18-07	-	Not sourced from SC
AD18-08	-	Not sourced from SC
AD18-09	-	Not sourced from SC
AD18-10	-	Not sourced from SC
AD18-11	-	Not sourced from SC
AD18-12	-	Not sourced from SC
AD19-01	S_PT_POS_HST_LS	FST_NAME
AD19-02	S_PT_POS_HST_LS	LAST_NAME
AD19-03	S_PT_POS_HST_LS	[LAST_NAME]+", "+[FST_NAME]
AD19-04	S_PT_POS_HST_LS	ROLE_CD
AD19-05	S_PT_POS_HST_LS	START_DT
AD19-06	S_PT_POS_HST_LS	END_DT
AD19-07	S_PT_POS_HST_LS	EMAIL_ADDR
AD19-08	S_PT_POS_HST_LS	COMMENTS
AD19-09	S_PT_POS_HST_LS	END_DT
AD20-01	-	Not sourced from SC
AD20-02	-	Not sourced from SC
AD20-03	-	Not sourced from SC
AD20-04	-	Not sourced from SC
AD20-05	-	Not sourced from SC
AD20-06	-	Not sourced from SC
AD20-07	S_CL_PTCL_LS	REGION_CD
AD20-08	-	Not sourced from SC
AD21-01	S_PT_POS_HST_LS	FST_NAME
AD21-02	S_PT_POS_HST_LS	LAST_NAME
AD21-03	S_PT_POS_HST_LS	[LAST_NAME]+", "+[FST_NAME]
AD21-04	S_PT_POS_HST_LS	ROLE_CD
AD21-05	S_PT_POS_HST_LS	START_DT
AD21-06	S_PT_POS_HST_LS	END_DT
AD21-07	S_PT_POS_HST_LS	EMAIL_ADDR
AD21-08	S_PT_POS_HST_LS	COMMENTS
AD21-09	S_PT_POS_HST_LS	END_DT
AD22-01	-	Not sourced from SC
AD22-02	-	Not sourced from SC
AD22-03	-	Not sourced from SC
AD22-04	-	Not sourced from SC
AD22-05	-	Not sourced from SC
AD22-06	-	Not sourced from SC
AD22-07	-	Not sourced from SC
AD22-08	-	Not sourced from SC
AD22-09	-	Not sourced from SC
AD22-10	-	Not sourced from SC
AD22-11	-	Not sourced from SC
AD22-12	-	Not sourced from SC
AD22-13	-	Not sourced from SC
M-ALL01	S_CL_SUBJ_ST_LS	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 and st_initn_cmpl_dt is not null group by ptcl_num order by 1
M-ALL02	S_PS_STMPVER_LS	select site_num, irb_apprv_dt "IRB_Approval_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id order by 1 From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT)Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-ALL03	S_CL_PTCL_LS	Protocol Approved Date cannot be sourced. min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT)
M-ALL04	S_CL_PTCL_LS	select ptcl_num, min(status_date) "First_Subj_Enrolled_Date" from s_cl_subj_ls, s_cl_ptcl_ls, S_PTCL_SITE_LS, S_CL_SUBJ_ST_LS where s_cl_subj_ls.PTCL_SITE_ID = S_PTCL_SITE_LS.row_id and S_PTCL_SITE_LS.cl_ptcl_id = s_cl_ptcl_ls.row_id and S_CL_SUBJ_ST_LS.par_subj_id = s_cl_subj_ls.row_id and S_CL_SUBJ_ST_LS.status_cd = 'Enrolled' group by ptcl_num order by 1 Protocol Approved Date cannot be sourced.
M-ALL05	S_CL_SUBJ_ST_LS	STATUS_DATE select ptcl_num, min(status_date) "First_Subj_Randomized_Date" from s_cl_subj_ls, s_cl_ptcl_ls, S_PTCL_SITE_LS, S_CL_SUBJ_ST_LS where s_cl_subj_ls.PTCL_SITE_ID = S_PTCL_SITE_LS.row_id and S_PTCL_SITE_LS.cl_ptcl_id = s_cl_ptcl_ls.row_id and S_CL_SUBJ_ST_LS.par_subj_id = s_cl_subj_ls.row_id and S_CL_SUBJ_ST_LS.status_cd = 'Randomized' group by ptcl_num order by 1 Protocol Approved Date cannot be sourced.
M-ALL06	S_CL_SUBJ_ST_LS	STATUS_DATE select ptcl_num, min(status_date) "First_Screen_Date" from s_cl_subj_ls, s_cl_ptcl_ls, S_PTCL_SITE_LS, S_CL_SUBJ_ST_LS where s_cl_subj_ls.PTCL_SITE_ID = S_PTCL_SITE_LS.row_id and S_PTCL_SITE_LS.cl_ptcl_id = s_cl_ptcl_ls.row_id and S_CL_SUBJ_ST_LS.par_subj_id = s_cl_subj_ls.row_id and S_CL_SUBJ_ST_LS.status_cd = 'Screened' group by ptcl_num order by 1 Protocol Approved Date cannot be sourced.
M-ALL07	-	"select site_num, st_initn_cmpl_dt ""Site_Initiation_Date"" from s_ptcl_site_ls order by 1 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site.S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'"
M-ALL08	S_EVT_ACT	select cl_ptcl_st_id, TODO_PLAN_START_DT "site_Visit_Start_Date", TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit'
M-ALL09	S_CL_PTCL_LS	select ptcl_num, count(*) from s_cl_ptcl_ls, S_PTCL_VER_LS where s_cl_ptcl_ls.row_id = cl_ptcl_id group by ptcl_num
M-ALL10	S_CL_PTCL_LS	select count(ptcl_num) from s_cl_ptcl_ls
M-ALL11	S_CL_PTCL_LS	Number of sites recruiting one or more subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >=1 group by ptcl_num
M-ALL12	S_CL_SUBJ_ST_LS	Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.NUM_PLAN_SUBJ > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)
M-ALL13	S_CL_PTCL_LS	1st Site Initiate can get from min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) To get LATEST Site Initiated Date, we have to use different table, column: max(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Ex: select max(ST_INITN_CMPL_DT) from S_PTCL_SITE_LS where CL_PTCL_ID = '1-4LOA'
M-ALL14	S_PTCL_SITE_LS.ST_INITN_CMPL_DT	1st site initiated can get from S_PTCL_SITE_LS.ST_INITN_CMPL_DT Ex: select max(ST_INITN_CMPL_DT) from S_PTCL_SITE_LS "Critical Document Package Completed Date" cannot be sourced.
M-ALL15	S_PS_STMPVER_LS S_CL_PTCL_LS	IRB_APPRV_DT select site_num, irb_apprv_dt "IRB_Approval_Date", st_initn_cmpl_dt "Site_Initiation_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls where S_PS_STMPVER_LS.ptcl_site_id = s_ptcl_site_ls.row_id order by 1
M-ALL16	S_EVT_ACT	TODO_ACTL_END_DT select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null
M-ALL17	S_EVT_ACT	TODO_ACTL_END_DT Site visit completed date can get from: select cl_ptcl_st_id, TODO_ACTL_END_DT "Visit_Completed_Date" from s_evt_act where subtype_cd = 'Site Visit' and TODO_ACTL_END_DT is not null Visit report approved date cannot be sourced.
M-ALL18	S_EVT_ACT	Site visit completed date can get from: select cl_ptcl_st_id, TODO_ACTL_END_DT "Site_Visit_Completed_Date", APPT_END_DT "Visit_Rep_Completed_Date" from s_evt_act where subtype_cd = 'Site Visit' and TODO_ACTL_END_DT is not null
M-ALL19	S_EVT_ACT	APPT_END_DT Visit Report Approved date cannot be sourced.
M-ALL20	S_CL_PTCL_LS	1st Site Initiate can get from min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Last cannot be determined, so this cannot be sourced.
M-ALL21	S_CL_PTCL_LS	DB_LOCK_DT Last subject last visit date cannot be sourced. Database Lock date for the protocol can get from: S_CL_PTCL_LS.DB_LOCK_DT
M-DOC01	S_EVT_ACT.ROW_ID	SUBTYPE_CD='Document'
M-DOC02	-	Calculated in RPD based on W_ACTIVITY_F.DOC_EXPIRATION_DT
M-DOC03	-	Calculated in RPD based on W_ACTIVITY_F.DOC_RECEIVED_DT and W_ACTIVITY_F.DOC_SENT_DT
M-DOC04	-	Calculated in RPD based on W_ACTIVITY_F.DOC_RECEIVED_DT
M-DRS01	-	Not sourced from SC
M-DRS02	-	Not sourced from SC
M-DRS03	-	Not sourced from SC
M-DRS04	-	Not sourced from SC
M-DSC01	-	Not sourced from SC
M-DSC02	-	Not sourced from SC
M-DSC03	-	Not sourced from SC
M-DSC04	-	Not sourced from SC
M-DSC09	-	Not sourced from SC
M-DSC11	-	Not sourced from SC
M-DSC12	-	Not sourced from SC
M-DSC15	-	Not sourced from SC
M-FUI01	-	Calculated in RPD based on W_RXI_FOLLOWUP_ITEM_F.FOLLOWUP_ITEM_CMPLT_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT
M-FUI02	-	Calculated in RPD based on W_RXI_FOLLOWUP_ITEM_F.FOLLOWUP_ITEM_CMPLT_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT
M-FUI03	-	Calculated in RPD based on W_RXI_FOLLOWUP_ITEM_F.FOLLOWUP_ITEM_CMPLT_DT
M-PRG01	S_CL_PTCL_LS	select s_cl_pgm_ls.name "Program_Name", min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", max(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "Latest_Site_Initiated_Date" from s_cl_pgm_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id group by s_cl_pgm_ls.name
M-PRG03	-	select s_cl_pgm_ls.name "Program_Name", irb_apprv_dt "IRB_Approval_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_A CT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-PRG04	S_PS_STMPVER_LS S_PTCL_SITE_LS	IRB_APPRV_DT ST_INITN_CMPL_DT
M-PRG06	-	select s_cl_pgm_ls.name "Program_Name", ptcl_num, min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date" from s_cl_pgm_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id order by 1,2 Protocol Approved Date cannot be sourced.
M-PRG07	-	select s_cl_pgm_ls.name "Program_Name", ptcl_num, min (s_cl_subj_st_ls.status_date) "First Subject Enrolled Date" from s_cl_pgm_ls, s_cl_ptcl_ls where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num order by 1,2 Protocol Approved Date cannot be sourced.
M-PRG08	-	select s_cl_pgm_ls.name "Program_Name", site_num "Site_Number", st_initn_cmpl_dt "Site_Initiation_Date" from s_ptcl_site_ls, s_cl_ptcl_ls, s_cl_pgm_ls where s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id and s_ptcl_site_ls.cl_ptcl_id = s_cl_ptcl_ls.row_id 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-PRG09	-	select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null and b.cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where cl_pgm_id in (select row_id from s_cl_pgm_ls where name = 'Anemia')))
M-PRG10	-	Site visit completed date in a program can get from: select s_cl_pgm_ls.name "Program_Name", site_num, TODO_ACTL_END_DT "Site_Visit_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' Visit report approved date cannot be sourced.
M-PRG11	-	select s_cl_pgm_ls.name "Program_Name", TODO_ACTL_END_DT "Site_Visit_Completed_Date", appt_end_dt "Visit_Rep_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null
M-PRG12	-	select s_cl_pgm_ls.name "Program_Name", ptcl_num, site_num, TODO_PLAN_START_DT "Site_Visit_Start_Date", TODO_ACTL_END_DT "Site_Visit_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null
M-PRG13	-	select s_cl_pgm_ls.name "Program_Name", ptcl_num, site_num, appt_end_dt "Visit_Rep_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null Visit Report Approved Date cannot be sourced.
M-PRG14	-	select ptcl_num, count(*) from s_cl_ptcl_ls, S_PTCL_VER_LS where s_cl_ptcl_ls.row_id = cl_ptcl_id group by ptcl_num
M-PRG15	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num order by 1
M-PRG16	-	select count(ptcl_num) from s_cl_ptcl_ls
M-PRG17	-	Number of sites recruiting one or more subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num
M-PRG18	-	Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and NUM_ENROLLED > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)
M-PRG19	S_PTCL_SITE_LS	ST_INITN_CMPL_DT Critical Document package Completed Date cannot be sourced
M-PRG20	-	SELECT s_cl_pgm_ls.name "Program_Name", ptcl_num, min(s_cl_subj_st_ls.status_date) "First_Subj_Screened_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_ls, s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Screened' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id and s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id group by s_cl_pgm_ls.name, ptcl_num Protocol approved date cannot be sourced.
M-PRG21	-	SELECT s_cl_pgm_ls.name "Program_Name", ptcl_num, min(s_cl_subj_st_ls.status_date) "First_Subj_Randomized_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_ls, s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Randomized' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id and s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id group by s_cl_pgm_ls.name, ptcl_num Protocol approved date cannot be sourced.
M-PRG22	-	select s_cl_pgm_ls.name "Program_Name", min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date" from s_cl_pgm_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id group by s_cl_pgm_ls.name Last site initiated date cannot be sourced.
M-PRG23	S_CL_PTCL_DT	DB_LOCK_DT Last subject last visit date cannot be sourced. Database Lock date for the protocol can get from: S_CL_PTCL_LS.DB_LOCK_DT
M-PRG24	S_EVT_ACT.APPT_START_DT	-
M-RCF01	-	Not sourced from SC
M-RCF05	-	Not sourced from SC
M-RCF06	-	Not sourced from SC
M-RCF07	-	Not sourced from SC
M-RCF08	-	Not sourced from SC
M-RCF09	-	Not sourced from SC
M-RCF10	-	Not sourced from SC
M-RCF11	-	Not sourced from SC
M-RCF13	-	Not sourced from SC
M-RCF14	-	Not sourced from SC
M-RCF15	-	Not sourced from SC
M-RCF16	-	Not sourced from SC
M-RCF17	-	Not sourced from SC
M-RCF18	-	Not sourced from SC
M-RCF19	-	Not sourced from SC
M-RCF20	-	Not sourced from SC
M-RCF21	-	Not sourced from SC
M-RCF21.1	-	Not sourced from SC
M-RCF22	-	Not sourced from SC
M-RCF23	-	Not sourced from SC
M-RCF24	-	Not sourced from SC
M-RCF25	-	Not sourced from SC
M-RCF26	-	Not sourced from SC
M-RCF29	-	Not sourced from SC
M-RCF29.1	-	Not sourced from SC
M-RCF30	-	Not sourced from SC
M-RCF31	-	Not sourced from SC
M-RCF31.1	-	Not sourced from SC
M-RCF32	-	Not sourced from SC
M-RCF33	-	Not sourced from SC
M-RCF34	-	Not sourced from SC
M-RCF35	-	Not sourced from SC
M-RCF36	-	Not sourced from SC
M-RCF37	-	Not sourced from SC
M-RCF38	-	Not sourced from SC
M-RCF39	-	Not sourced from SC
M-RCF40	-	Not sourced from SC
M-RCF41	-	Not sourced from SC
M-RCF42	-	Not sourced from SC
M-RCF43	-	Not sourced from SC
M-RCF44	-	Not sourced from SC
M-RCF45	-	Not sourced from SC
M-RCF45.1	-	Not sourced from SC
M-RCF46	-	Not sourced from SC
M-RCF47	-	Not sourced from SC
M-RCF48	-	Not sourced from SC
M-RCF49	-	Not sourced from SC
M-RCF49.1	-	Not sourced from SC
M-RCF49.2	-	Not sourced from SC
M-RCF50	-	Not sourced from SC
M-RCF52	-	Not sourced from SC
M-RCF52.1	-	Not sourced from SC
M-RCF55.1	-	Not sourced from SC
M-RCF55.2	-	Not sourced from SC
M-RCF58	-	Not sourced from SC
M-RCF62	-	Not sourced from SC
M-RCF62.1	-	Not sourced from SC
M-RCF62.2	-	Not sourced from SC
M-RCF63	-	Not sourced from SC
M-RCF64	-	Not sourced from SC
M-RCF64.1	-	Not sourced from SC
M-RCF64.2	-	Not sourced from SC
M-RCF64.3	-	Not sourced from SC
M-RCF64.4	-	Not sourced from SC
M-RCF65	-	Not sourced from SC
M-RCF68	-	Not sourced from SC
M-RCF69	-	Not sourced from SC
M-RCF70	-	Not sourced from SC
M-RCF71.1	-	Not sourced from SC
M-RCF72	-	Not sourced from SC
M-RCF73	-	Not sourced from SC
M-RCF74	-	Not sourced from SC
M-RCF74.1	-	Not sourced from SC
M-RCF75	-	Not sourced from SC
M-RCF76	-	Not sourced from SC
M-RCF77	-	Not sourced from SC
M-RCF78	-	Not sourced from SC
M-RCF81	-	Not sourced from SC
M-RCF82	-	Not sourced from SC
M-RCF83	-	Not sourced from SC
M-RCF84	-	Not sourced from SC
M-RCF85	-	Not sourced from SC
M-RCF86	-	Not sourced from SC
M-REG05	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num order by 1
M-REG07	-	Number of initiated sites recruiting one or more subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num Number of sites initiated against each protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num
M-REG09	-	Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and NUM_ENROLLED> 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) Number of sites initiated against each protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and NUM_ENROLLED >= 1 group by ptcl_num
M-REG10	-	select region_cd "Region", ptcl_num, site_num, min(st_initn_cmpl_dt) "Site_Initiated_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id group by region_cd,ptcl_num, site_num order by 1,2,3 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-REG11	-	select region_cd "Region", ptcl_num, site_num, irb_apprv_dt "IRB_Approval_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-REG12	-	select region_cd "Region",ptcl_num,site_num, irb_apprv_dt "IRB_Approval_Date", st_initn_cmpl_dt "Site_Initiation_Date" from S_PS_STMPVER_LS, s_cl_ptcl_ls, s_ptcl_site_ls where S_PS_STMPVER_LS.ptcl_site_id = s_ptcl_site_ls.row_id and s_cl_ptcl_ls.row_id = cl_ptcl_id order by 1
M-REG14	-	select count(ptcl_num) from s_cl_ptcl_ls
M-REG15	-	select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, min(st_initn_cmpl_dt) "Site_Initiated_Date", min(status_date) "First_Subj_Enrolled_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_st_ls, s_cl_subj_ls where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id and s_cl_subj_st_ls.status_cd = 'Enrolled' group by s_cl_pgm_ls.name, region_cd, ptcl_num, site_num order by 1,2,3
M-REG16	-	select s_cl_pgm_ls.name "Program_Name", region_cd "Region",ptcl_num, site_num, ST_INITN_CMPL_DT "Site_Initiation_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id Critical Document package Completed Date cannot be sourced
M-REG17	-	select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null and b.cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where region_cd = 'USA'))
M-REG18	-	Site visit completed date in a program can get from: select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, TODO_ACTL_END_DT "Site_Visit_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' order by 1,2,3,4 Visit report approved date cannot be sourced.
M-REG19	-	select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, TODO_ACTL_END_DT "Site_Visit_Completed_Date", appt_end_dt "Visit_Rep_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' order by 1,2,3,4 Visit Report Completed date cannot be sourced.
M-REG20	-	select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, appt_end_dt "Visit_Rep_Completed_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls,s_evt_act where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_evt_act.cl_ptcl_st_id and TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' order by 1,2,3,4 Visit Report Approved Date cannot be sourced.
M-SBVT03	S_EVT_ACT	TODO_ACTL_END_DT
M-SBVT04	S_EVT_ACT	CMPLTD_FLG
M-SBVT05	S_EVT_ACT	NAME
M-SBVT06	S_EVT_ACT	APPT_START_DT
M-SBVT07	S_EVT_ACT_LSX	MAX_DUE_DT
M-SBVT08	S_EVT_ACT_LSX	MIN_DUE_DT
M-SBVT09	S_EVT_ACT	TODO_PLAN_START_DT
M-SBVT10	S_CL_CFT_LS	PTCL_DEV_FLG
M-SBVT11	S_CL_CFT_LS	PTCL_VLTN_FLG
M-SBVT12	S_EVT_ACT_LSX	EVT_PRRTY_SEQ
M-SBVT13	S_SBJTMP_VER_LS	NAME
M-SBVT14	S_EVT_ACT	TODO_CD
M-SIV01	-	Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_APRVD_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT
M-SIV02	-	Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_CMPLT_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT
M-SIV03	-	Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_START_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_CMPLT_DT
M-SIV04	-	Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_CMPLT_DT and W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_APRVD_DT
M-SIV05	-	Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_APRVD_DT
M-SIV06	-	Calculated in RPD based on W_RXI_SITE_VISIT_D.SITE_VISIT_REPORT_CMPLT_DT
M-SIV07	-	-
M-SIV08	-	-
M-SIV10	-	-
M-SRG01	S_CL_PTCL_LS.NUM_PLAN_SITE	-
M-SRG02	S_CL_PTCL_LS.NUM_PLAN_SUBJ	-
M-SRG03	-	select S_CL_pgm_ls.name "Program_Name", ptcl_name, min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) from s_cl_pgm_ls, s_cl_ptcl_ls where S_CL_pgm_ls.row_id = cl_pgm_id order by S_CL_pgm_ls.name, ptcl_name
M-SRG04	-	Get the number of sites planned for a study from: S_CL_PTCL_LS.NUM_PLAN_SITE. Get the number of sites initiated in a study using below query: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.st_initn_cmpl_dt is not null group by ptcl_num
M-SRG05	-	To get LATEST Site Initiated Date, we have to use different table, column: max(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Ex: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, max(ST_INITN_CMPL_DT) "Latest_Site_Initiated_Date" from s_cl_pgm_ls,s_cl_ptcl_ls,S_PTCL_SITE_LS where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_ptcl_ls.row_id = cl_ptcl_id group by s_cl_pgm_ls.name,region_cd,ptcl_num
M-SRG06	-	First Site Initiated: min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Latest site initiated date can get from: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num,max(ST_INITN_CMPL_DT) "Latest_Site_Initiated_Date" from s_cl_pgm_ls,s_cl_ptcl_ls, s_ptcl_site_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_cl_pgm_ls.row_id = cl_pgm_id group by s_cl_pgm_ls.name,region_cd,ptcl_num
M-SRG07	-	select s_cl_pgm_ls.name "Program_Name", region_cd "Region", ptcl_num, site_num, min(irb_apprv_dt) "IRB_Approval_Date" from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS, s_evt_act where s_evt_act.CL_SUBJ_ID is not null and subtype_cd = 'Visit' and s_evt_act.cl_ptcl_st_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.cl_pgm_id = s_cl_pgm_ls.row_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id group by s_cl_pgm_ls.name,region_cd,ptcl_num, site_num order by 1,2,3
M-SRG08	-	select s_cl_pgm_ls.name"Program_Name",region_cd "Region",ptcl_num, min (s_cl_subj_st_ls.status_date) -min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "No_Of_Days" from s_cl_pgm_ls,s_cl_ptcl_ls where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num
M-SRG09	-	select count(*) from s_evt_act where par_evt_id in (select activity_uid from s_evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where region_cd = 'USA'))) and subtype_cd = 'Follow-Up'
M-SRG10	-	Get planned subjects of a site from: S_PTCL_SITE_LS.NUM_PLAN_SUBJ. There is no direct column to get the number of subjects randomized. Use below query to get it: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num,site_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls, s_cl_subj_ls, S_CL_SUBJ_ST_LS where s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_cl_subj_ls.PTCL_SITE_ID = s_ptcl_site_ls.row_id and S_CL_SUBJ_ST_LS.par_subj_id = s_cl_subj_ls.row_id and S_CL_SUBJ_ST_LS.status_cd = 'Randomized' group by s_cl_pgm_ls.name,region_cd,ptcl_num,site_num
M-SRG11	S_CL_PTCL_LS.NUM_PLAN_SUBJ S_CL_PTCL_LS.NUM_SUBJ_ENRL	-
M-SRG12	-	1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V' To get Latest Subject 1st Visit: From S_CL_SUBJ_LS, we have to find out the latest subject (ROW_ID) using max(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null
M-SRG13	-	select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, min(TODO_ACTL_END_DT) "1st_Subject_1st_Visit_Date", min(irb_apprv_dt) "1st_IRB_Approved_Date" from s_cl_pgm_ls,s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS, s_Evt_act where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and subtype_cd = 'Visit' and cl_ptcl_st_id = s_ptcl_site_ls.row_id group by s_cl_pgm_ls.name,region_cd,ptcl_num
M-SRG14	-	select region_cd "Region",ptcl_num, min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", min(irb_apprv_dt) "1st_IRB_Approved_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id group by region_cd,ptcl_num
M-SRG16	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.st_initn_cmpl_dt is not null group by ptcl_num
M-SRG23	-	select region_cd "Region",ptcl_num,ptcl_site_id, irb_apprv_dt "IRB_Approval_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls, s_cl_ptcl_ls where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2,3 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-SRG24	-	select region_cd "Region",ptcl_num,cl_ptcl_st_id, min(st_initn_cmpl_dt) "Site_Initiation_Date", min(irb_apprv_dt) "IRB_Approval_Date" from S_PS_STMPVER_LS, s_evt_act, s_ptcl_site_ls, s_cl_ptcl_ls where s_evt_act.CL_SUBJ_ID is not null and subtype_cd = 'Visit' and s_evt_act.cl_ptcl_st_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id group by region_cd,ptcl_num,cl_ptcl_st_id order by 1
M-SRG25	-	select region_cd "Region",ptcl_num,site_num, st_initn_cmpl_dt "Site_Initiation_Date" from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2,3 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-SRG26	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id group by ptcl_num
M-SRG27	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num
M-SRG28	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num
M-SRG29	-	Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.NUM_PLAN_SUBJ > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)
M-SRG30	-	select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where s_cl_pgm_ls.row_id = cl_pgm_id and cl_ptcl_id = s_cl_ptcl_ls.row_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 and st_initn_cmpl_dt is not null group by s_cl_pgm_ls.name,region_cd,ptcl_num order by 1,2,3
M-SRG31	-	select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 and s_cl_pgm_ls.row_id = s_cl_ptcl_ls.cl_pgm_id group by s_cl_pgm_ls.name,region_cd,ptcl_num order by 1 Number of sites initiated against each protocol: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null group by s_cl_pgm_ls.name,region_cd,ptcl_num order by 1,2,3
M-SRG32	-	Number of sites which enrolled atleast 90% of planned subjects in a protocol: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls, s_cl_ptcl_ls, s_ptcl_site_ls where s_cl_pgm_ls.row_id = cl_pgm_id and cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.NUM_PLAN_SUBJ > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by s_cl_pgm_ls.name,region_cd,ptcl_num order by 1,2,3 Number of sites initiated against each protocol: select s_cl_pgm_ls.name "Program_Name",region_cd "Region",ptcl_num, count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls where s_cl_pgm_ls.row_id = cl_pgm_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null group by s_cl_pgm_ls.name,region_cd,ptcl_num Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)
M-SRG33	-	Not sourced from SC
M-SRG34	-	Not sourced from SC
M-SST01	S_PTCL_SITE_LS.NUM_PLAN_SUBJ	-
M-SST02	S_PTCL_SITE_LS.NUM_SUBJ_ENRL	-
M-SST02C	S_CL_SUBJ_LS.PR_STATUS_ID	Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD="Enrolled"
M-SST03	S_PTCL_SITE_LS.NUM_SUBJ_ENRL+S_PTCL_SITE_LS.NUM_COMPLTD	-
M-SST04	S_PTCL_SITE_LS.NUM_SUBJ_ENRL	-
M-SST05	S_PTCL_SITE_LS.NUM_COMPLTD	-
M-SST05C	S_CL_SUBJ_LS.PR_STATUS_ID	Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD="Completed"
M-SST06	S_PTCL_SITE_LS.NUM_ERLY_TERM	-
M-SST06C	S_CL_SUBJ_LS.PR_STATUS_ID	Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD="Early Terminated"
M-SST08	-	Not sourced from SC
M-SST09	-	Not sourced from SC
M-SST15.1	(S_PTCL_SITE_LS.NUM_SUBJ_ENRL/ S_PTCL_SITE_LS.NUM_PLAN_SUBJ) * 100	-
M-SST17	-	Not sourced from SC
M-SST18	-	Not sourced from SC
M-SST19	-	Not sourced from SC
M-SST20	-	Not sourced from SC
M-SST21	-	Not sourced from SC
M-SST23	-	Not sourced from SC
M-SST24	-	Not sourced from SC
M-SST24.1	-	Not sourced from SC
M-SST24.2	-	Not sourced from SC
M-SST24.3	-	Not sourced from SC
M-SST27	-	Not sourced from SC
M-SST28	-	Not sourced from SC
M-SST29	-	Not sourced from SC
M-SST30	-	Not sourced from SC
M-SST31	-	Not sourced from SC
M-SST32	S_CL_SUBJ_ST_LS.STATUS_CD	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'
M-SST32C	S_CL_SUBJ_LS.PR_STATUS_ID	Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD='Randomized'
M-SST33	S_CL_SUBJ_LS.STATUS_CD	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Re-Screened'
M-SST33C	S_CL_SUBJ_LS.PR_STATUS_ID	Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD='Re-Screened'
M-SST34	S_CL_SUBJ_ST_LS.STATUS_CD	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screen Failure'
M-SST34C	S_CL_SUBJ_LS.PR_STATUS_ID	Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD='Screen Failure'
M-SST35	S_CL_SUBJ_LS.STATUS_CD	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'
M-SST35C	S_CL_SUBJ_LS.PR_STATUS_ID	Count of S_CL_SUBJ_LS.ROW_ID Where S_CL_SUBJ_LS.PR_STATUS_ID = S_CL_SUBJ_ST_LS.ROW_ID and S_CL_SUBJ_ST_LS.STATUS_CD='Screened'
M-SST36	S_CL_SUBJ_LS.INTEGRATION_ID	-
M-SST37	S_CL_SUBJ_LS.PTCL_DEV_FLG	-
M-SST38	S_CL_SUBJ_LS.PTCL_VLTN_FLG	-
M-SST39	S_PTCL_SITE_LS.ST_INITN_CMPL_DT	-
M-SST40	S_CL_SUBJ_LS.WTHDWN_DT	-
M-SST41	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Completed'
M-SST42	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'
M-SST43	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'
M-SST44	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'
M-SST45	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Completed'
M-SST46	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'
M-SST47	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'
M-SST48	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'
M-SST49	COUNT (S_PTCL_SITE_LS.ROW_ID)	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'
M-SST50	S_EVT_ACT.DOC_SENT_DT - S_EVT_ACT.DOC_RCVD_DT	-
M-SST51	S_EVT_ACT.DOC_SENT_DT - Current timestamp	Where S_EVT_ACT.DOC_RCVD_DT is null
M-SST52	Current timestamp - M-SST46	-
M-SST54	M-SST02 / # Subjects Enrolled at Study	-
M-SST55	M-SST32 / # Randomized at Study	-
M-SST56	M-SST35 / # Screened at Study	-
M-SST57	M-SST06 / M-SST02	Total for Study-site
M-SST58	M-SST06 / M-SST02	Total for Study
M-SST59	M-SST51 / # Documents	-
M-SST60	Avg (M-SST50)	-
M-SST61	-	-
M-SST62	-	-
M-SST63	-	Current date- latest site visit Completed date
M-SST65	-	Count(W_RXI_SITE_VISIT_F.ROW_WID)
M-SST66	-	Count (S_CL_SUBJ_ST_LS.ROW_ID) from S_CL_SUBJ_ST_LS, S_EVT_ACT SiteVisit, S_CL_SUBJ_LS where S_CL_SUBJ_ST_LS.STATUS_CD = 'Enrolled' and S_CL_SUBJ_ST_LS.STATUS_DATE > (MAX (SiteVisit.TODO_ACTL_END_DT) and SiteVisit.SUBTYPE_CD = "Site Visit" and SiteVisit.CL_PTCL_ST_ID = S_CL_SUBJ_LS.PTCL_SITE_ID and S_CL_SUBJ_ST_LS.PAR_SUBJ_ID = S_CL_SUBJ_LS.ROW_ID
M-SST67	-	Count (S_CL_SUBJ_ST_LS.ROW_ID) from S_CL_SUBJ_ST_LS, S_EVT_ACT SiteVisit, S_CL_SUBJ_LS where S_CL_SUBJ_ST_LS.STATUS_CD = 'Randomized' and S_CL_SUBJ_ST_LS.STATUS_DATE > (MAX (SiteVisit.TODO_ACTL_END_DT) and SiteVisit.SUBTYPE_CD = "Site Visit" and SiteVisit.CL_PTCL_ST_ID = S_CL_SUBJ_LS.PTCL_SITE_ID and S_CL_SUBJ_ST_LS.PAR_SUBJ_ID = S_CL_SUBJ_LS.ROW_ID
M-SST68	-	Count (S_CL_SUBJ_ST_LS.ROW_ID) from S_CL_SUBJ_ST_LS, S_EVT_ACT SiteVisit, S_CL_SUBJ_LS where S_CL_SUBJ_ST_LS.STATUS_CD = 'Screened' and S_CL_SUBJ_ST_LS.STATUS_DATE > (MAX (SiteVisit.TODO_ACTL_END_DT) and SiteVisit.SUBTYPE_CD = "Site Visit" and SiteVisit.CL_PTCL_ST_ID = S_CL_SUBJ_LS.PTCL_SITE_ID and S_CL_SUBJ_ST_LS.PAR_SUBJ_ID = S_CL_SUBJ_LS.ROW_ID
M-SST69	-	When Visit report completed date is NOT null
M-SST70	-	When Visit report completed date is NOT null and visit report approval date is also null then count record
M-SST71	-	when site visit complete date IS NOT NULL and visit report complete date both are IS null then count
M-SST72	-	M-SST32 # Subjects Randomized / M-SST01 # Subjects Planned for Study-Site
M-SST73	-	Min(when site visit start date> AD10-41 Site initiated date, return site visit start date)
M-SST74	-	Max (when site visit complete date <= current date, site visit complete date)
M-SST75	-	Max(when site visit start date <= current date, return site visit start date)
M-SST76	-	select cl_ptcl_st_id, TODO_PLAN_START_DT "Site_Visit_Start_Date" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where site_num = 'US-001' and cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374')) order by cl_ptcl_st_id, TODO_PLAN_START_DT
M-SST77	-	select cl_ptcl_st_id, count(*) "No_Of_Follow_Up_Items" from s_evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Follow-Up' group by cl_ptcl_st_id
M-SST78	-	Min(when site visit start date> current date , return site visit start date)
M-SST79	S_EVT_ACT.TODO_ACTL_END_DT	select min(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, MAX(STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled" And S_CL_SUBJ_LS.PTCL_SITE_ID = row_id of the site you are calculating this for)
M-SST80	s_evt_act.TODO_ACTL_END_DT	-
M-SST81	-	select max (S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, MAX (STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled" And S_CL_SUBJ_LS.PTCL_SITE_ID = row_id of the site you are calculating this for)
M-SST82	-	1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V' and site initiated date can get from: S_PTCL_SITE_LS.ST_INITN_CMPL_DT
M-SST83	-	select site_num, irb_apprv_dt "IRB_Approved_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id order by 1 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-SST84	-	SELECT site_num, irb_apprv_dt-ST_INITN_CMPL_DT "No_Of_Days" from s_ptcl_site_ls, S_PS_STMPVER_LS where ptcl_site_id = s_ptcl_site_ls.row_id
M-SST85	-	site initiated date can get from: S_PTCL_SITE_LS.ST_INITN_CMPL_DT Critical document package completed date cannot be sourced.
M-SST86	S_CL_SUBJ_ST_LS	select site_num,to_char(enrl_dt, 'Month'), count(*) from S_cl_subj_ls,s_ptcl_site_ls,s_cl_ptcl_ls where enrl_dt is not null and ptcl_site_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.SITE_TERM_DT is not null and enrl_dt >= st_initn_cmpl_dt group by site_num,to_char(enrl_dt, 'Month') order by 2
M-SST87	S_CL_SUBJ_ST_LS	The number of subjects screened against each site can get from: select site_num, count(*) from s_cl_subj_ls, s_ptcl_site_ls, S_CL_SUBJ_ST_LS where ptcl_site_id = s_ptcl_site_ls.row_id and s_cl_subj_ls.row_id = S_CL_SUBJ_ST_LS.PAR_SUBJ_ID and s_cl_subj_ls.screen_dt is not null and S_CL_SUBJ_ST_LS.status_cd = 'Screened' group by site_num order by 1 The number of subjects screen failed against each site : select site_num, count(*) from s_cl_subj_ls, s_ptcl_site_ls, S_CL_SUBJ_ST_LS where ptcl_site_id = s_ptcl_site_ls.row_id and s_cl_subj_ls.row_id = S_CL_SUBJ_ST_LS.PAR_SUBJ_ID and s_cl_subj_ls.screen_dt is not null and S_CL_SUBJ_ST_LS.status_cd = 'Screen Failure' group by site_num order by 1
M-SST88	S_CL_PTCL_LS S_CL_SUBJ_LS	site_num enrl_dt num_subj_enrl num_plan_subj
M-SST89	-	Not sourced from SC
M-SST90	-	Not sourced from SC
M-SST91	-	Not sourced from SC
M-SST92	-	Not sourced from SC
M-SST93	S_CL_PTCL_LS	select site_num, fst_subj_enrl_dt-ST_INITN_CMPL_DT "No_Of_Days" from s_ptcl_site_ls
M-SST94	S_CL_PTCL_LS.NUM_PLAN_SUBJ S_CL_PTCL_LS.NUM_SUBJ_ENRL	-
M-SST95	-	Not sourced from SC
M-SST96	S_EVT_ACT	select min(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, min (STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled" And S_CL_SUBJ_LS.PTCL_SITE_ID = row_id of the site you are calculating this for)
M-SST97	-	See Flag section
M-SST98	-	See Flag section
M-SST99	-	See Flag section
M-SST100	-	See Flag section
M-SST101	-	See Flag section
M-SST102	-	See Flag section
M-SST103	-	See Flag section
M-SST104	-	See Flag section
M-SST105	-	See Flag section
M-SST106	-	See Flag section
M-SST107	-	See Flag section
M-STD02	S_CL_PTCL_LS.NUM_PLAN_SUBJ	-
M-STD06	S_CL_PTCL_LS.DB_LOCK_DT	-
M-STD07	COUNT (S_PTCL_SITE_LS.ROW_ID)	-
M-STD08	S_PTCL_SITE_LS.NUM_SUBJ_ENRL	-
M-STD09	S_EVT_ACT.TODO_PLAN_START_DT S_EVT_ACT.	Where TODO_ACTL_END_DT is not null
M-STD10	-	M-SST32 # Subjects Randomized / M-STD02 # Subjects Planned for Study
M-STD11	-	Min(AD10-41 Study site Initiated Date)
M-STD12	-	Max(AD10-41 Study site Initiated Date)
M-STD13	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.st_initn_cmpl_dt is not null group by ptcl_num
M-STD14	-	Not sourced from SC
M-STD15	-	From S_CL_SUBJ_LS, we have to find out the latest subject (ROW_ID) using max(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get max(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null
M-STD16	-	Not sourced from SC
M-STD17	-	Not sourced from SC
M-STD18	-	Not sourced from SC
M-STD20	-	select ptcl_num, site_num "Site_Number", ST_INITN_CMPL_DT "Site_Initiated_Date" from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-STD21	-	select ptcl_num, irb_apprv_dt "IRB_Approval_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-STD22	-	select ptcl_num, site_num, irb_apprv_dt "IRB_Approval_Date", st_initn_cmpl_dt "Site_Initiation_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id order by 1,2
M-STD23	S_CL_PTCL_LS.NUM_PLAN_SUBJ S_CL_PTCL_LS.NUM_SUBJ_ENRL	-
M-STD24	-	select ptcl_num, min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", min (s_cl_subj_st_ls.status_date) "1st_Subj_Enroll_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id and s_cl_subj_st_ls.status_cd = 'Enrolled' and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num group by ptcl_num
M-STD25	-	select ptcl_num, min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", max(st_initn_cmpl_dt) "Latest_Site_Initiated_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id group by ptcl_num
M-STD26	-	1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V' Latest subject 1st visit can get from: From S_CL_SUBJ_LS, we have to find out the latest subject (ROW_ID) using max(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_S ITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null
M-STD27	-	select ptcl_num, irb_apprv_dt "1st_IRB_Approved_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id order by 1 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and
M-STD28	-	Number of planned sites for a protocol can get from: S_CL_PTCL_LS.NUM_PLAN_SITE Number of sites initiated in a protocol can get from: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null group by ptcl_num
M-STD29	-	Number of sites which are initiated recruiting 0 subjects: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num
M-STD30	-	Number of sites recruiting one or more subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num Number of sites initiated against each protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) >= 1 group by ptcl_num
M-STD31	-	Number of sites which enrolled atleast 90% of planned subjects in a protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and NUM_ENROLLED > 0 and NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Number of sites initiated against each protocol: select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and ST_INITN_CMPL_DT is not null and NUM_ENROLLED >= 1 group by ptcl_num Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)
M-STD32	-	select site_num,min(irb_apprv_dt) from S_PS_STMPVER_LS, s_ptcl_site_ls where ptcl_site_id = s_ptcl_site_ls.row_id group by site_num order by 1
M-STD40	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.ST_INITN_CMPL_DT is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by ptcl_num order by 1
M-STD42	-	select ptcl_num, count(*) from s_ptcl_site_ls, s_cl_ptcl_ls where cl_ptcl_id = s_cl_ptcl_ls.row_id and s_ptcl_site_ls.ST_INITN_CMPL_DT is not null and s_ptcl_site_ls.NUM_PLAN_SUBJ > 0 and (NUM_ENROLLED/s_ptcl_site_ls.NUM_PLAN_SUBJ*100 >= 90) group by ptcl_num order by 1 Get NUM_ENROLLED by: count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)
M-STD43	-	The number of subjects enrolled per month in a protocol which does not have a database lock date: select ptcl_num, to_char(enrl_dt, 'Month'), count(*) from S_cl_subj_ls,s_ptcl_site_ls,s_cl_ptcl_ls where enrl_dt is not null and ptcl_site_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.cl_ptcl_id = s_cl_ptcl_ls.row_id and s_cl_ptcl_ls.db_lock_dt is null group by ptcl_num,to_char(enrl_dt, 'Month') order by 2 The number of subjects enrolled per month in a protocol which have a database lock date: select ptcl_num, to_char(enrl_dt, 'Month'), count(*) from S_cl_subj_ls,s_ptcl_site_ls,s_cl_ptcl_ls where enrl_dt is not null and ptcl_site_id = s_ptcl_site_ls.row_id and s_ptcl_site_ls.cl_ptcl_id = s_cl_ptcl_ls.row_id and s_cl_ptcl_ls.db_lock_dt is not null group by ptcl_num,to_char(enrl_dt, 'Month') order by 2
M-STD44	-	Not sourced from SC
M-STD45	-	Not sourced from SC
M-STD46	-	Not sourced from SC
M-STD47	-	Not sourced from SC
M-STD48	-	select count(ptcl_num) from s_cl_ptcl_ls
M-STD49	-	select cl_ptcl_st_id, TODO_PLAN_START_DT "Site_Visit_Start_Date" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374')) order by cl_ptcl_st_id, TODO_PLAN_START_DT
M-STD50	-	select count(*) from s_evt_act where par_evt_id in (select activity_uid from s_evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374'))) and subtype_cd = 'Follow-Up'
M-STD51	-	Not sourced from SC
M-STD52	-	select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null and b.cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374'))
M-STD53	-	select ptcl_num,site_num,TODO_ACTL_END_DT "Site_Visit_Completed_Dt" from s_cl_ptcl_ls, s_ptcl_site_ls, s_evt_act where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and TODO_ACTL_END_DT is not null and subtype_Cd = 'Site Visit' and s_evt_act.cl_ptcl_st_id = s_ptcl_site_ls.row_id order by 1,2 Visit Report Approved Date cannot be sourced.
M-STD54	-	select ptcl_num,site_num,TODO_ACTL_END_DT "Site_Visit_Completed_Dt", appt_end_dt "Visit_Rep_Completed_Dt" from s_cl_ptcl_ls, s_ptcl_site_ls, s_evt_act where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and TODO_ACTL_END_DT is not null and subtype_Cd = 'Site Visit' and s_evt_act.cl_ptcl_st_id = s_ptcl_site_ls.row_id order by 1,2
M-STD55	-	Not sourced from SC
M-STD56	-	select ptcl_num, min(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) "1st_Site_Initiated_Date", min(irb_apprv_dt) "1st_IRB_Approved_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, S_PS_STMPVER_LS where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_id group by ptcl_num
M-STD57	-	Not sourced from SC
M-STD58	-	Not sourced from SC
M-STD59	-	Not sourced from SC
M-STD60	-	select ptcl_num, site_num "Site_Number", min(ST_INITN_CMPL_DT) "Site_Initiated_Date",min (s_cl_subj_st_ls.status_date)"1st_Subj_Enroll_Dt" from s_ptcl_site_ls, s_cl_ptcl_ls where s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num group by ptcl_num,site_num order by 1,2 Get FST_SBJ_ENRL_DT by: select min (s_cl_subj_st_ls.status_date) where s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num
M-STD61	-	SELECT s_cl_ptcl_ls.ptcl_num, min (s_cl_subj_st_ls.status_date) "1st_Subj_Enroll_Date", max(s_cl_subj_st_ls.status_date) "Latest_Subj_Enroll_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_ls, s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by s_cl_ptcl_ls.ptcl_num
M-STD62	-	Not sourced from SC
M-STD63	S_EVT_ACT.APPT_END_DT	-
M-STD64	-	Not sourced from SC
M-STD65	-	Not sourced from SC
M-STD66	-	Not sourced from SC
M-STD67	-	Not sourced from SC
M-STD68	-	Not sourced from SC
M-STD69	-	Not sourced from SC
M-STD70	-	Not sourced from SC
M-STD71	-	See Flag section
M-STD72	-	See Flag section
M-STD73	-	See Flag section
M-STD74	-	See Flag section
M-STD75	-	See Flag section
M-STD76	-	See Flag section
M-STD77	-	See Flag section
M-STD78	-	See Flag section
M-STD79	-	See Flag section
M-STD80	-	See Flag section
M-STD81	-	See Flag section
M-STD82	-	See Flag section
M-STD83	-	Select Count (S_CL_SUBJ_ST_LS.PAR_SUBJ_ID) From S_CL_SUBJ_ST_LS, S_PTCL_SITE_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Screen Failure" And S_CL_SUBJ_LS.PTCL_SITE_ID = S_PTCL_SITE_LS.ROW_ID And S_PTCL_SITE_LS.CL_PTCL_ID = row_id of the study you are calculating this for) / Select Count (S_CL_SUBJ_ST_LS.PAR_SUBJ_ID) From S_CL_SUBJ_ST_LS, S_PTCL_SITE_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Screened" And S_CL_SUBJ_LS.PTCL_SITE_ID = S_PTCL_SITE_LS.ROW_ID And S_PTCL_SITE_LS.CL_PTCL_ID = row_id of the study you are calculating this for)
M-STD84	-	select min(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, min (STATUS_DATE) From S_CL_SUBJ_ST_LS, S_PTCL_SITE_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled" And S_CL_SUBJ_LS.PTCL_SITE_ID = S_PTCL_SITE_LS.ROW_ID And S_PTCL_SITE_LS.CL_PTCL_ID = row_id of the study you are calculating this for)
M-STD85	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'
M-STD86	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'
M-STD87	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'
M-STD88	S_EVT_ACT.TODO_ACTL_END_DT	select min (S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, MAX (STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = "Enrolled")
M-STD89	-	SELECT max (s_cl_subj_st_ls.status_date) from s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Enrolled'
M-STD90	S_EVT_ACT.TODO_ACTL_END_DT	select max(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V'
M-STD91	-	SELECT max (s_cl_subj_st_ls.status_date) from s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Randomized'
M-STR01	-	count (S_CL_SUBJ_ST_LS.STATUS_CD = "Early Terminated")/ count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled)
M-STR02	-	SELECT region_cd "Region",s_cl_ptcl_ls.ptcl_num, min (s_cl_subj_st_ls.status_date) "1st_Sub_Enroll_Date",max(s_cl_subj_st_ls.status_date) "Latest_Subj_Enroll_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_ls, s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Enrolled' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id group by region_cd,s_cl_ptcl_ls.ptcl_num
M-STR03	S_CL_PTCL_LS S_CL_SUBJ_LS	site_num enrl_dt num_subj_enrl num_plan_subj
M-STR04	-	Not sourced from SC
M-STR05	-	Not sourced from SC
M-STR06	-	Not sourced from SC
M-STR07	S_CL_PTCL_LS. S_CL_PTCL_LS.	NUM_SCRN_FAIL NUM_SUBJ_SCRN
M-STR08	-	select region_cd "Region", ptcl_num, site_num, min(st_initn_cmpl_dt) "Site_Initiated_Date", min(status_date) "First_Subj_Enrolled_Date" from s_cl_ptcl_ls, s_ptcl_site_ls, s_cl_subj_st_ls, s_cl_subj_ls where s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_cl_subj_ls.ptcl_site_id and s_cl_subj_ls.row_id = s_cl_subj_st_ls.par_subj_id and s_cl_subj_st_ls.status_cd = 'Enrolled' group by region_cd, ptcl_num, site_num order by 1,2,3
M-STR09	-	Not sourced from SC
M-STR10	-	Not sourced from SC
M-STR11	S_EVT_ACT.TODO_PLAN_START_DT	select cl_ptcl_st_id, TODO_PLAN_START_DT "Site_Visit_Start_Date" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where region_cd = 'USA')) order by cl_ptcl_st_id, TODO_PLAN_START_DT
M-STR12	-	Not sourced from SC
M-STR13	-	Not sourced from SC
M-STR14	-	Not sourced from SC
M-STR15	-	Not sourced from SC
M-STR16	S_EVT_ACT	TODO_PLAN_START_DT TODO_ACTL_END_DT select region_cd "Region",ptcl_num,cl_ptcl_st_id, TODO_PLAN_START_DT "site_Visit_Start_Date", TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt" from s_cl_ptcl_ls,s_ptcl_site_ls,s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and s_cl_ptcl_ls.row_id = s_ptcl_site_ls.cl_ptcl_id and s_ptcl_site_ls.row_id = s_Evt_act.cl_ptcl_st_id
M-STR17	-	(S_PTCL_SITE_LS.NUM_SUBJ_ENRL/ S_PTCL_SITE_LS.NUM_PLAN_SUBJ) * 100
M-STR18	-	Not sourced from SC
M-STR19	-	Not sourced from SC
M-STR20	-	Not sourced from SC
M-STR21	-	See Flag section
M-STR22	-	See Flag section
M-STR23	-	See Flag section
M-STR24	-	See Flag section
M-STR25	-	See Flag section
M-STR26	-	See Flag section
M-STR27	-	See Flag section
M-STR28	-	See Flag section
M-STR29	-	See Flag section
M-STR30	S_CL_PTCL_LS	NUM_PLAN_SUBJ NUM_PLAN_SITE NUM_SUBJ_ENRL
M-STR31	S_EVT_ACT.TODO_ACTL_END_DT	select min(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V'
M-STR32	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'
M-STR33	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Randomized'
M-STR34	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'
M-STR35	S_EVT_ACT.TODO_ACTL_END_DT	select min (S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V' and S_EVT_ACT.CL_SUBJ_ID = (Select S_CL_SUBJ_ST_LS.PAR_SUBJ_ID, MAX (STATUS_DATE) From S_CL_SUBJ_ST_LS Where S_CL_SUBJ_ST_LS.STATUS_CD = ""Enrolled"")
M-STR36	-	SELECT max (s_cl_subj_st_ls.status_date) from s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Enrolled'
M-STR37	S_EVT_ACT.TODO_ACTL_END_DT	select max(S_EVT_ACT.TODO_ACTL_END_DT) from S_EVT_ACT where S_EVT_ACT.TEMPLATE_FLG = 'V'
M-STR38	-	SELECT max (s_cl_subj_st_ls.status_date) from s_cl_subj_st_ls where s_cl_subj_st_ls.status_cd = 'Randomized'
M-TA01	S_CL_PTCL_LS	NUM_PLAN_SUBJ NUM_PLAN_SITE NUM_SUBJ_ENRL SELECT S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME, count(*) "Num_Of_Sites_Initiated" FROM S_CL_PGM_LS, S_PTCL_SITE_LS, S_CL_PTCL_LS WHERE S_CL_PGM_LS.ROW_ID = S_CL_PTCL_LS.CL_PGM_ID AND S_CL_PTCL_LS.ROW_ID = S_PTCL_SITE_LS.CL_PTCL_ID AND ST_INITN_CMPL_DT IS NOT NULL GROUP BY S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME order by S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME
M-TA03	S_CL_PTCL_LS	To get LATEST Site Initiated Date, we have to use different table, column: max(S_PTCL_SITE_LS.ST_INITN_CMPL_DT) Ex: select max(ST_INITN_CMPL_DT) from S_PTCL_SITE_LS where CL_PTCL_ID = '1-4LOA' min (S_PTCL_SITE_LS.ST_INITN_CMPL_DT)
M-TA05	S_PS_STMPVER_LS S_CL_PTCL_LS	select site_num, irb_apprv_dt "IRB_Approval_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls where s_ptcl_site_ls.row_id = S_PS_STMPVER_LS.ptcl_site_idorder by 1 From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-TA06	S_PS_STMPVER_LS S_CL_PTCL_LS	select site_num, irb_apprv_dt "IRB_Approval_Date", st_initn_cmpl_dt "Site_Initiation_Date" from S_PS_STMPVER_LS, s_ptcl_site_ls where S_PS_STMPVER_LS.ptcl_site_id = s_ptcl_site_ls.row_id order by 1
M-TA07	-	Not sourced from SC
M-TA08	-	Not sourced from SC
M-TA09	S_CL_SUBJ_LS	select site_num, st_initn_cmpl_dt "Site_Initiation_Date" from s_ptcl_site_ls order by 1 1st Subject 1st Visit can get from: From S_CL_SUBJ_LS, we have to find out the first subject (ROW_ID) using min(CREATED) in a particular protocol site. S_CL_SUBJ_LS.ROW_ID is the subject id (CL_SUBJ_ID in S_EVT_ACT) Using the CL_SUBJ_ID, get min(TODO_ACTL_END_DT) from S_EVT_ACT & SITE_NUM from S_PTCL_SITE_LS Join Condition between tables: s_evt_act.cl_subj_id is not null and s_cl_subj_ls.row_id = s_Evt_act.CL_SUBJ_ID and s_ptcl_site_ls.site_uid = s_cl_subj_ls.ptcl_site_id and s_evt_act.TODO_ACTL_END_DT is not null and S_EVT_ACT.TEMPLATE_FLG = 'V'
M-TA10	S_CL_PGM_LS S_CL_PTCL_LS	NAME select S_CL_PGM_LS.name, count(*) from S_CL_PGM_LS, S_CL_PTCL_LS where S_CL_PTCL_LS.CL_PGM_ID = S_CL_PGM_LS.ROW_ID group by S_CL_PGM_LS.name This query should give the number of protocols against each program/Therapeutic Area.
M-TA11	S_EVT_ACT	select a.cl_ptcl_st_id, b.TODO_ACTL_END_DT "Site_Visit_Cmpl_Dt", a.TODO_ACTL_END_DT "Follow_Up_Item_Cmpl_Dt" from s_Evt_act a, s_evt_act b where a.par_evt_id = b.activity_uid and a.subtype_cd = 'Follow-Up' and b.subtype_cd = 'Site Visit' and b.TODO_ACTL_END_DT is not null and a.TODO_ACTL_END_DT is not null and b.cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where cl_ptcl_id in (select row_id from s_cl_ptcl_ls where cl_pgm_id in (select row_id from s_cl_pgm_ls where name = 'Anemia')))
M-TA12	S_EVT_ACT	TODO_ACTL_END_DT WHERE SUBTYPE_CD = 'Site Visit'
M-TA13	S_EVT_ACT	TODO_ACTL_END_DT WHERE SUBTYPE_CD = 'Site Visit'
M-TA14	S_EVT_ACT	TODO_ACTL_END_DT TODO_PLAN_START_DT WHERE SUBTYPE_CD = 'Site Visit'
M-TA15	-	Not sourced from SC
M-TA16	-	Not sourced from SC
M-TA20	S_PTCL_SITE_LS	SITE_NUM NUM_SUBJ_ENRL select s_cl_pgm_ls.name "Program_Name",Ptcl_num,count(*) from s_cl_pgm_ls,s_cl_ptcl_ls,s_ptcl_site_ls WHERE s_ptcl_site_ls.st_initn_cmpl_dt is not null and count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) =0 group by s_cl_pgm_ls.name,Ptcl_num order by 1,2
M-TA21	S_PTCL_SITE_LS	SITE_NUM NUM_SUBJ_ENRL select count(*) from s_ptcl_site_ls WHERE count (S_CL_SUBJ_ST_LS.STATUS_CD = Enrolled) > 1 To get number of sites initiated: SELECT S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME, count(*) "Num_Of_Sites_Initiated" FROM S_CL_PGM_LS, S_PTCL_SITE_LS, S_CL_PTCL_LS WHERE S_CL_PGM_LS.ROW_ID = S_CL_PTCL_LS.CL_PGM_ID AND S_CL_PTCL_LS.ROW_ID = S_PTCL_SITE_LS.CL_PTCL_ID AND ST_INITN_CMPL_DT IS NOT NULL GROUP BY S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME order by S_CL_PGM_LS.NAME, S_CL_PTCL_LS.PTCL_NAME
M-TA22	-	Not sourced from SC
M-TA23	-	Not sourced from SC
M-TA24	-	Not sourced from SC
M-TA25	-	Not sourced from SC
M-TA26	-	Not sourced from SC
M-TA27	S_EVT_ACT	select cl_ptcl_st_id, TODO_PLAN_START_DT "Site_Visit_Start_Date" from s_Evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Site Visit' and cl_ptcl_st_id in (select row_id from s_ptcl_site_ls where site_num = 'US-001' and cl_ptcl_id in (select row_id from s_cl_ptcl_ls where ptcl_num = 'AMXN 9374')) order by cl_ptcl_st_id, TODO_PLAN_START_DT
TA-DISC01	-	Not sourced from SC
TA-DISC02	-	Not sourced from SC
TA-DISC03	-	Not sourced from SC
TA-DISC04	-	Not sourced from SC
TA-DISC05	-	Not sourced from SC
TA-DISC06	-	Not sourced from SC
TA-DISC07	-	Not sourced from SC
TA-DISC08	-	Not sourced from SC
TA-DISC09	-	Not sourced from SC
TA-DISC10	-	Not sourced from SC
TA-DISC11	-	Not sourced from SC
TA-DISC12	-	Not sourced from SC
TA-DISC13	-	Not sourced from SC
TA-DISC14	-	Not sourced from SC
TA-DISC15	-	Not sourced from SC
TA-DISC16	-	Not sourced from SC
TA-DISC17	-	Not sourced from SC
TA-DISC19	-	Not sourced from SC
TA-DISC20	-	Not sourced from SC
TA-DISC21	-	Not sourced from SC
TA-DISC22	-	Not sourced from SC
TA-DISC22.1	-	Not sourced from SC
TA-DISC23	-	Not sourced from SC
TA-DISC24	-	Not sourced from SC
TA-DISC25	-	Not sourced from SC
TA-DISC26	-	Not sourced from SC
TA-DISC26.1	-	Not sourced from SC
TA-DISC30	-	Not sourced from SC
TA-DISC31	-	Not sourced from SC
TA-DISC32	-	Not sourced from SC
TA-DISC33	-	Not sourced from SC
TA-DOC01	S_EVT_ACT.SUBTYPE_CD	-
TA-DOC02	S_EVT_ACT.COMMENTS_LONG	-
TA-DOC03	S_EVT_ACT.NAME	-
TA-DOC04	S_EVT_ACT.TODO_CD	-
TA-DOC05	S_EVT_ACT.DOC_EXPCTD_DT	-
TA-DOC06	S_EVT_ACT.DOC_RCVD_DT	-
TA-DOC07	S_EVT_ACT.DOC_SENT_DT	-
TA-DOC08	S_EVT_ACT.APPT_END_DT	-
TA-DOC09	-	""Study Level Document"" WHEN s_evt_act.CL_PTCL_ID is not null AND S_CL_PTCL_LS.REGION_CD is null Join using where s_evt_act.CL_PTCL_ID = S_CL_PTCL_LS.row_id ""Region Level Document"" WHEN s_evt_act.CL_PTCL_ID is not null AND S_CL_PTCL_LS.REGION_CD is NOT null Join using where s_evt_act.CL_PTCL_ID = S_CL_PTCL_LS.row_id ""Site Level Document"" WHEN s_evt_act.TARGET_OU_ID is not null ""Contact Level Document"" WHEN s_evt_act.TARGET_PER_ID is not null ""Study-Site Level Document"" WHEN s_evt_act.CL_PTCL_ST_ID is not null
TA-FUI01	S_EVT_ACT.COMMENTS	-
TA-FUI02	S_EVT_ACT.TODO_ACTL_END_DT	-
TA-FUI03	S_EVT_ACT.CREATED	-
TA-FUI04	S_EVT_ACT.NAME	-
TA-FUI05	S_EVT_ACT.APPT_START_DT	-
TA-FUI06	S_EVT_ACT.EVT_STAT_CD	-
TA-FUI07	S_EVT_ACT.TODO_CD	-
TA-FUI08	S_EVT_ACT.ROW_ID	-
TA-RCRF01	-	Not sourced from SC
TA-RCRF02	-	Not sourced from SC
TA-RCRF03	-	Not sourced from SC
TA-RCRF04	-	Not sourced from SC
TA-RCRF05	-	Not sourced from SC
TA-RCRF06	-	Not sourced from SC
TA-RCRF07	-	Not sourced from SC
TA-RCRF08	-	Not sourced from SC
TA-RCRF09	-	Not sourced from SC
TA-RCRF10	-	Not sourced from SC
TA-RCRF11	-	Not sourced from SC
TA-RCRF12	-	Not sourced from SC
TA-RCRF13	-	Not sourced from SC
TA-RCRF14	-	Not sourced from SC
TA-RCRF15	-	Not sourced from SC
TA-RCRF16	-	Not sourced from SC
TA-RCRF17	-	Not sourced from SC
TA-RCRF19	-	Not sourced from SC
TA-RCRF20	-	Not sourced from SC
TA-RCRF22	-	Not sourced from SC
TA-RCRF23	-	Not sourced from SC
TA-RCRF24	-	Not sourced from SC
TA-RCRF25	-	Not sourced from SC
TA-RCRF26	-	Not sourced from SC
TA-RCRF28	-	Not sourced from SC
TA-RCRF29	-	Not sourced from SC
TA-RCRF30	-	Not sourced from SC
TA-RCRF31	-	Not sourced from SC
TA-RCRF32	-	Not sourced from SC
TA-RCRF33	-	Not sourced from SC
TA-RCRF34	-	Not sourced from SC
TA-RCRF35	-	Not sourced from SC
TA-SITE01	S_PS_STMPVER_LS.IRB_APPRV_DT	-
TA-SIV01	S_EVT_ACT.COMMENTS_LONG	-
TA-SIV02	S_EVT_ACT.TODO_ACTL_END_DT	-
TA-SIV03	S_EVT_ACT.NAME	-
TA-SIV04	-	Not sourced from SC
TA-SIV05	S_EVT_ACT.APPT_END_DT	-
TA-SIV06	S_EVT_ACT.SRA_STAT_CD	-
TA-SIV07	S_EVT_ACT.APPT_START_DT	-
TA-SIV08	S_EVT_ACT.EVT_STAT_CD	-
TA-SIV09	S_EVT_ACT.TODO_CD	-
TA-SIV10	S_EVT_ACT.S_TMPL_PLANITEM.NAME	S_EVT_ACT.TEMPLATE_ID = S_TMPL_PLANITEM.ROWID
TA-SIV11	S_ECT_ACT.ROW_ID	-
TA-SUBJ01	S_CL_SUBJ_ST_LS.STATUS_CD	-
TA-SUBJ02	S_CL_SJ_CSNT_LS.INFO_CONSNT_DT	S_CL_SJ_CSNT_LS.CL_SUBJ_ID = S_CL_SUBJ_LS.ROW_ID S_CL_SJ_CSNT_LS.SUBJ_TMPL_VER_ID = S_SBJTMP_VER_LS.ROW_ID
TA-SUBJ03	S_CL_SUBJ_ST_LS.COMMENTS	-
TA-SUBJ04	S_EVT_ACT	TODO_ACTL_END_DT select min(TODO_ACTL_END_DT) from S_EVT_ACT where subtype_cd = 'Visit'
TA-SUBJ05	S_EVT_ACT	TODO_ACTL_END_DT select cl_subj_id,max(TODO_ACTL_END_DT) "Subj_Visit_Cmpl_Dt" from S_EVT_ACT where subtype_cd = 'Visit' and cl_subj_id is not null and TODO_ACTL_END_DT is not null group by cl_subj_id
TA-SUBJ06	S_EVT_ACT	select cl_subj_id, count(*) from s_evt_act where TODO_ACTL_END_DT is not null and subtype_cd = 'Visit' group by cl_subj_id
TA-SUBJ07	S_EVT_ACT	There is no direct column to get this measure. select cl_subj_id, count(*) from s_evt_act where Template_FLG = 'V' and TODO_PLAN_START_DT is not null and TODO_PLAN_START_DT < ETL_RUN_DATE and TODO_ACTL_END_DT is null group by cl_subj_id
TA-SUBJ08	S_EVT_ACT	There is no direct column to get this measure. select cl_subj_id, count(*) from s_evt_act where TODO_PLAN_START_DT > sysdate and subtype_cd = 'Visit' group by cl_subj_id
TA-SUBJ09	-	Not sourced from SC
TD01-01	S_CL_PTCL_LS.PTCL_NUM	-
TD01-02	S_CL_SUBJ_LS.SUBJ_NUM	-
TD01-03	-	Not sourced from SC
TD01-04	-	Not sourced from SC
TD01-05	S_CL_SUBJ_ST_LS.STATUS_CD	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Early Terminated'
TD01-06	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Enrolled'
TD01-07	-	Not sourced from SC
TD01-08	S_CL_SUBJ_LS.SUBJ_INITL	-
TD01-09	S_CL_SUBJ_LS.BIRTH_DT	-
TD01-10	-	Not sourced from SC
TD01-11	S_CL_SUBJ_ST_LS.STATUS_CD	-
TD01-12	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Early Terminated'
TD01-16	-	Not sourced from SC
TD01-17	S_CL_SUBJ_ST_LS.STATUS_DATE	S_LST_OF_VAL,TYPE='CLNCL_SUBJECT_STATUS' and NAME='Screened'
TD01-18	S_CL_SUBJ_LS.ELGBL_FLG	-
TD01-19	S_CL_SUBJ_LS.COMMENTS	-
TD01-20	S_CL_SUBJ_LS.ENRL_NUM	-
TD01-21	S_CL_SUBJ_LS.RDMZATN_NUM	-
TD01-22	S_CL_SUBJ_LS.PTCL_VLTN_FLG	-
TD01-23	S_CL_SUBJ_LS.EXCLD_RSN_CD	-
TD01-24	S_CL_SUBJ_LS.SUBJ_NUM+BIRTH_DT	-
TD01-25	S_CL_SUBJ_LS.PTCL_DEV_FLG	-
TD01-26	S_CL_SUBJ_LS.WTHDWN_RSN_CD	-
TD01-27	.CURRENT_DATE - BIRTH_DT	-
TD01-28	S_CL_SUBJ_ST_LS.STATUS_DATE	-
TD01-29	-	Not sourced from SC
TD01-30	S_CL_SUBJ_LS.ROW_ID	-
AD09-75	S_CL_PTCL_LS.OBJECTIVE_DESC	-
AD09-76	S_ASSESS. ASSESS_TMPL_NAME	-
AD09-77	S_ASSESS. LAST_UPD	-
AD09-78	S_ASSESS. NAME	-
AD09-79	S_ASSESS.DESC_TEXT	-
AD09-81	-	Not sourced from SC
AD09-82	-	Not sourced from SC
AD09-83	-	Not sourced from SC
AD09-84	-	Not sourced from SC
AD09-85	-	Not sourced from SC
AD09-86	-	Not sourced from SC
AD09-87	-	Not sourced from SC
AD09-88	-	Not sourced from SC
AD10-78	S_PTCL_SITE_LS. MAX_ENROLLMENT	-
AD10-79	S_ASSESS. ASSESS_TMPL_NAME	-
AD10-80	S_ASSESS. LAST_UPD	-
AD10-81	S_ASSESS. NAME	-
AD10-82	S_PTCL_SITE_LS. SDV_TYPE_CD	-
AD10-82	S_PTCL_SITE_LS. SDV_TYPE_CD	-
AD16-17	S_ASSESS. ASSESS_TMPL_NAME	-
AD16-18	S_ASSESS. LAST_UPD	-
AD16-19	S_ASSESS. NAME	-
AD16-20	S_ASSESS.DESC_TEXT	-
AD16-21	S_ASSESS. SCORE	-
AD17-48	S_ASSESS. ASSESS_TMPL_NAME	-
AD17-49	S_ASSESS. LAST_UPD	-
AD17-50	S_ASSESS. NAME	-
AD17-51	S_ASSESS.DESC_TEXT	-
AD18-13	-	Not sourced from SC
AD18-14	-	Not sourced from SC
AD18-15	-	Not sourced from SC
AD18-16	-	Not sourced from SC
AD18-17	-	Not sourced from SC
AD18-18	-	Not sourced from SC
AD18-19	-	Not sourced from SC
AD18-20	-	Not sourced from SC
AD18-21	-	Not sourced from SC
AD18-22	-	Not sourced from SC
AD23-01	-	Not sourced from SC
AD23-02	-	Not sourced from SC
AD23-03	S_ASSESS_VAL . ATTRIB_NAME	- Note: This column is a concatenation of Category + : + Question. For this measure source only the substring before the first ": " If field does not have a ":" or begins with a ":", then use the category "No Category".
AD23-04	-	Not sourced from SC
AD23-05	-	Not sourced from SC
AD23-07	-	Not sourced from SC
M-PRR01	-	Not sourced from SC
M-PRR02	-	Not sourced from SC
M-PRR03	-	Not sourced from SC
M-PRR04	S_ASSESS_VAL .SCORE	-
M-PRR05	S_ASSESS_VAL .COMMENTS	-
M-PRR06	S_ASSESS_VAL .SEQUENCE_NUM	-
M-PRR07	-	Not sourced from SC
M-PRR08	S_ASSESS_VAL . ATTRIB_NAME	-
M-PRR09	-	Not sourced from SC
M-PRR10	Impact (M-PRR04)	-
M-PRR11	S_ASSESS_VAL . WEIGHT	-
M-PRR12	Avg of child question scores	-
M-PTL01	S_PTCL_VER_LS. AMND_VERSION	-
M-PTL02	S_PTCL_VER_LS. VER_CREATED_DT	-
M-PTL03	S_PTCL_VER_LS. ORIG_VER_FLG	-
M-PTL04	-	Not sourced from SC
M-PTL05	-	Not sourced from SC
M-PTL06	S_PTCL_VER_LS. COMMENTS	-
M-SDR01	-	Not sourced from SC
M-SDR02	-	Not sourced from SC
M-SDR03	-	Not sourced from SC
M-SDR04	S_ASSESS_VAL . SCORE	-
M-SDR05	S_ASSESS_VAL .COMMENTS	-
M-SDR06	S_ASSESS_VAL .SEQUENCE_NUM	-
M-SDR07	-	Not sourced from SC
M-SDR08	S_ASSESS_VAL . ATTRIB_NAME	-
M-SDR09	-	Not sourced from SC
M-SDR10	Impact (M-SDR04)	-
M-SDR11	S_ASSESS_VAL . WEIGHT	-
M-SDR12	Avg of child question scores	-
M-SRG36	S_CL_PTCL_LS.INIT_NUM_OF_SUBJ	-
M-SRG37	S_CL_PTCL_LS. SEL_CL_SUBJ_PCT	-
M-SRR01	-	Not sourced from SC
M-SRR02	-	Not sourced from SC
M-SRR03	-	Not sourced from SC
M-SRR04	S_ASSESS_VAL . SCORE	-
M-SRR05	S_ASSESS_VAL .COMMENTS	-
M-SRR06	S_ASSESS_VAL .SEQUENCE_NUM	-
M-SRR07	-	Not sourced from SC
M-SRR08	S_ASSESS_VAL . ATTRIB_NAME	-
M-SRR09	-	Not sourced from SC
M-SRR10	Impact (M-SRR04)	-
M-SRR11	S_ASSESS_VAL . WEIGHT	-
M-SRR12	Avg of child question scores	-
M-SSR01	-	Not sourced from SC
M-SSR02	-	Not sourced from SC
M-SSR03	-	Not sourced from SC
M-SSR04	S_ASSESS_VAL . SCORE	-
M-SSR05	S_ASSESS_VAL .COMMENTS	-
M-SSR06	S_ASSESS_VAL .SEQUENCE_NUM	-
M-SSR07	-	Not sourced from SC
M-SSR08	S_ASSESS_VAL . ATTRIB_NAME	-
M-SSR09	-	Not sourced from SC
M-SSR10	Impact (M-SSR04)	-
M-SSR11	S_ASSESS_VAL . WEIGHT	-
M-SSR12	Avg of child question scores	-
M-SST107	S_PTCL_SITE_LS.INIT_NUM_OF_SUBJ	-
M-SST108	S_PTCL_SITE_LS. SEL_CL_SUBJ_PCT	-
M-STD100	-	Not sourced from SC
M-STD101	-	Not sourced from SC
M-STD102	-	Not sourced from SC
M-STD103	-	Not sourced from SC
M-STD104	-	Not sourced from SC
M-STD105	-	Not sourced from SC
M-STD106	-	Not sourced from SC
M-STD107	-	Not sourced from SC
M-STD108	-	Not sourced from SC
M-STD109	-	Not sourced from SC
M-STD110	-	Not sourced from SC
M-STD111	-	Not sourced from SC
M-STD112	-	Not sourced from SC
M-STD113	-	Not sourced from SC
M-STD114	-	Count of all versions of a protocol that are not the original version that have been flagged as avoidable.
M-STD115	S_CL_PTCL_LS.INIT_NUM_OF_SUBJ	-
M-STD116	S_CL_PTCL_LS.SEL_CL_SUBJ_PCT	-
M-STD93	-	Not sourced from SC
M-STD94	-	Not sourced from SC
M-STD95	-	Not sourced from SC
M-STD96	-	Not sourced from SC
M-STD97	-	Not sourced from SC
M-STD98	-	Not sourced from SC
M-STD99	-	Not sourced from SC
TA-SIV12	S_EVT_ACT_LSX. REVIEWED_TS	-
TA-SIV13	S_EVT_ACT_LSX. REVIEW_COMMENTS	-
TA-SIV14	Employee Last, First Name; Join on S_EVT_ACT_LSX. REVIEWER_ID	-
TA-SIV15	Employee Last, First Name; Join on S_EVT_ACT_LSX. APPROVER_ID	-
TA-SUBJ10	S_CL_SUBJ_LS.	-
TA-SUBJ11	S_CL_SUBJ_LS .SDV_UPD_TYPE_CD	-

Oracle Health Sciences InForm Sources for OHSCDA Presentation Catalog

Table B-6 Presentation Catalog - InForm Sources

Attribute ID	Source Table/Column	Comments/Details
AD11-02	IRV_FORM_REVS.FORMNAME	-
AD11-02	IRV_FORM_REVS.FORMNAME	-
AD11-04	IRV_FORM_REVS.FORMMNEMONIC	-
AD11-01	IRV_STUDYVERSIONS.STUDYNAME	-
AD04-06	IRV_CUR_SITE_V.SITECITY UNION IRV_CUR_USER_V.USERCITY where IRV_CUR_USER_V.rightsgroup = 'PI'	-
AD04-03	IRV_CUR_SITE_V.SITECOUNTRY UNION IRV_CUR_USER_V.USERCOUNTRY where IRV_CUR_USER_V.rightsgroup = 'PI'	-
AD04-07	IRV_CUR_SITE_V.SITEPOSTALCODE UNION IRV_CUR_USER_V.USERPOSTALCODE where IRV_CUR_USER_V.rightsgroup = 'PI'	-
AD04-04	IRV_CUR_SITE_V.SITESTATEPROVINCE UNION IRV_CUR_USER_V.USERSTATEPROVINCE where IRV_CUR_USER_V.rightsgroup = 'PI'	-
AD05-05	IRV_CUR_USER_V.USERCITY	-
AD05-08	IRV_CUR_USER_V.USERCOUNTRY	-
AD05-13	IRV_CUR_USER_V.USERFIRSTNAME	-
AD05-14	IRV_CUR_USER_V.USERLASTNAME||', '||USERFIRSTNAME	-
AD05-02	IRV_CUR_USER_V.USERLASTNAME	-
AD05-03	IRV_CUR_USER_V.USERLASTNAME||', '||USERFIRSTNAME	-
AD05-01	IRV_CUR_USER_V.USERLASTNAME	-
AD05-15	IRV_CUR_USER_V.USERADDRESS1	-
AD05-12	IRV_CUR_USER_V.USERDAYPHONENUMBER	-
AD05-06	IRV_CUR_USER_V.USERPOSTALCODE	-
AD05-07	IRV_CUR_USER_V.USERSTATEPROVINCE	-
AD05-04	IRV_CUR_USER_V.USERADDRESS1	-
AD05-17	IRV_CUR_USER_V.USERADDRESS1	-
AD05-18	IRV_CUR_USER_V.USERADDRESS2	-
AD05-10	IRV_CUR_USER_V.USERDAYPHONENUMBER	-
AD18-01	IRV_CUR_USER_V.USERDAYPHONENUMBER	-
AD07-01	IRV_STUDYVERSIONS.SPONSORDRUGNAME	-
AD08-03	IRV_CUR_SITE.SITECOUNTRY	-
AD08-11	IRV_CUR_SITE.SITESTATEPROVINCE	-
AD08-02	IRV_CUR_SITE.SITESTATEPROVINCE	-
AD09-03	RXI_CUR_SPONSOR.PROGRAMNAME	-
AD09-01	IRV_STUDYVERSIONS.STUDYNAME	-
AD09-05	RXI_CUR_SPONSOR.SPONSORNAME	-
AD10-22	IRV_CUR_USER.username	-
AD10-05	IRV_CUR_SPONSOR.PROGRAMNAME	-
AD10-01	IRV_CUR_SITE.SITENAME	-
AD10-04	IRV_CUR_SITE.STUDYNAME	-
AD10-26	IRV_CUR_SPONSOR.SPONSORNAME	-
AD10-02	IVR_CUR_SITE.STUDYNAME || ':' || SITENAME	-
TD01-09	IRV_CUR_SUBJECT.SUBJECTDOB	-
TD01-06	IRV_CUR_SUBJECT.SUBJECTENROLLDATE	-
TD01-07	IRV_CUR_SUBJECT.SUBJECTSTATETEXT	-
TD01-04	IRV_CUR_SUBJECT.BOOKLOCKED	-
TD01-01	IRV_STUDYVERSIONS.STUDYNAME	-
TD01-02	IRV_CUR_SUBJECT.IRV_CUR_SUBJECT.SUBJECTNUMBERSTR	-
TD01-08	IRV_CUR_SUBJECT.SUBJECTINITIALS	-
TD01-11	IRV_CUR_SUBJECT.SUBJECTSTATETEXT	-
AD13-01	IRV_STUDYVERSIONS.STUDYNAME	-
AD13-03	IRV_CUR_RULE.RULEDESCRIPTION	-
AD13-02	IRV_CUR_RULE.RULEREFNAME	-
M-DSC03	-	-
M-DSC11	-	-
M-DSC15	-	-
M-DSC02	-	-
M-DSC01	-	-
TA-DISC09	IRV_CUR_QUERY.VISITID||'.'||VISITINDEX	-
TA-DISC13	RXI_FORM_REVS.FORMNAME	-
TA-DISC11	IRV_AF_SUBJECT_FORMS.FMINSTARTEDSTATE	-
TA-DISC12	IRV_FORM_REVS.FORMNAME	-
TA-DISC14	IRV_SECTION_REVS.SECTIONHEADER	-
TA-DISC15	IRV_ITEMSET_REVS.ITEMSETREFNAME	-
TA-DISC16	IRV_ITEM_REVS.ITEMQUESTION	-
TA-DISC21	IRV_CUR_QUERY.QUERYSTATE	-
TA-DISC26.1	IRV_CUR_QUERY.QMAXANSWERED	-
TA-DISC26	IRV_CUR_QUERY.QMAXCLOSED	-
TA-DISC30	IRV_CUR_QUERY.LASTCANDIDATETEXT,LASTOPENEDTEXT,LASTANSWEREDTEXT,LASTDELETEDTEXT,LASTCLOSEDTEXT	-
TA-DISC25	IRV_CUR_QUERY.QUERYSTATETIME	-
TA-DISC01	IRV_CUR_QUERY.QUERYID	-
TA-DISC22.1	IRV_CUR_QUERY.QUERYSTATE	-
TA-DISC22	IRV_CUR_QUERY.QUERYSTATE	-
TA-DISC04	PIRC_INV.USERLASTNAME||', '||USERFIRSTNAME	-
TA-DISC32	IRV_CUR_QUERY.QUERYTYPE	-
TA-DISC03	RXI_CUR_SITE. SITENAME	-
TA-DISC02	IRV_STUDYVERSIONS.STUDYNAME	-
TA-DISC33	IRV_CUR_SITE.STUDYNAME ||':'|| SITENAME	-
TA-DISC05	IRV_CUR_SUBJECT.SUBJECTNUMBERSTR	-
TA-DISC10	IRV_SV_SUBJECTVISITS .DOV	-
TA-DISC06	IRV_STUDYVERSION_VISITS.VISITNAME	-
TA-DISC07	IRV_CUR_QUERY.VISITID	-
TA-DISC20	IRV_CUR_RULE.IRV_CUR_RULE.RULEREFNAME	-
M-DRS03	IRV_QUERY_STATE_CHANGES.QUERYSTATE	-
M-DRS04	IRV_QUERY_STATE_CHANGES.QUERYSTATE	-
M-DRS02	IRV_QUERY_STATE_CHANGES.QUERYSTATE	-
M-DRS01	IRV_QUERY_STATE_CHANGES.QUERYSTATE	-
M-RCF18	IRV_AF_SUBJECT_FORMS.startedstate AND completestate	-
M-RCF09	IRV_AF_SUBJECT_FORMS.notdonestate	-
M-RCF01	IRV_AF_SUBJECT_FORMS.startedstate AND completestate	-
M-RCF81	IRV_AF_SUBJECT_FORMS.notdonestate	-
M-RCF68	IRV_AF_SUBJECT_FORMS.startedstate AND completestate	-
M-RCF70	IRV_AF_SUBJECT_FORMS.FMINSIGNEDSTATE	-
M-RCF69	IRV_AF_SUBJECT_FORMS.FMINSDVCOMPLETESTATE	-
M-RCF25	IRV_AF_SUBJECT_FORMS.FMINSIGNEDSTATE	-
M-RCF23	IRV_AF_SUBJECT_FORMS.FMINSDVCOMPLETESTATE	-
TA-RCRF09	IRV_AF_SUBJECT_FORMS.VISITORDER||:||VISITINDEX	-
TA-RCRF11	IRV_FORM_REVS.FORMNAME	-
TA-RCRF35	.EDC'	-
TA-RCRF01	IRV_AF_SUBJECT_FORMS.FORMORDER	-
TA-RCRF14	IRV_AF_SUBJECT_FORMS.VISIT_FIRST_ENTRY	-
TA-RCRF34	IRV_AF_SUBJECT_FORMS.CASE WHEN IRV_AF_SUBJECT_FORMS.LOCKEDSTATE = 1 AND FMAXLOCKEDSTATE IS NOT NULL THEN FMAXLOCKEDSTATE ELSE NULL;	-
TA-RCRF32	IRV_AF_SUBJECT_FORMS.FMINSIGNEDSTATE	-
TA-RCRF30	IRV_AF_SUBJECT_FORMS.FMINSDVCOMPLETESTATE	-
TA-RCRF04	IRV_CUR_USER.username	-
TA-RCRF20	IRV_AF_SUBJECT_FORMS.Case when status_code ='complete' and approval_status_code ='not signed' and initial_approval_dt is not null then 'Y' else 'N' end	-
TA-RCRF17	IRV_AF_SUBJECT_FORMS.Case when status_code ='complete' and VERFCTN_STATUS_CODE in ('SDV Partially Complete', 'Ready for SDV but Unstarted') and INITIAL_SRC_VERFCTN_DT is not null then 'Y' else 'N' end	-
TA-RCRF22	IRV_AF_SUBJECT_FORMS.NOTDONESTATE	-
TA-RCRF26	.If status_code ='Complete' then 'Y' else 'N'	-
TA-RCRF28	IRV_AF_SUBJECT_FORMS.CASE WHEN IRV_AF_SUBJECT_FORMS.LOCKEDSTATE = 1 AND FMAXLOCKEDSTATE IS NOT NULL THEN 'Y' ELSE 'N';	-
TA-RCRF19	IRV_AF_SUBJECT_FORMS.Case when status_code ='complete' and APPROVAL_STATUS_CODE = 'Nt Signed' and INITIAL_APPROVAL_DT is NULL then 'Y' else 'N' end.	-
TA-RCRF16	IRV_AF_SUBJECT_FORMS.Case when status_code = 'Complete' and INITIAL_SRC_VERFCTN_DT IS NULL 'Y' else 'N' end	-
TA-RCRF23	IRV_AF_SUBJECT_FORMS.case when IRV_AF_SUBJECT_FORMS.FROZENSTATE = 1 AND FMAXFROZENSTATE IS NOT NULL then 'Y' else 'N' end;	-
TA-RCRF33	IRV_AF_SUBJECT_FORMS.FMAXSIGNEDSTATE	-
TA-RCRF31	IRV_AF_SUBJECT_FORMS.FMAXSDVCOMPLETESTATE	-
TA-RCRF13	IRV_FORM_REVS and IRV_STUDYVERSION_VISITS.VISITNAME||':'||FORMNAME	-
TA-RCRF15	IRV_AF_SUBJECT_FORMS. INF CRF STATUS CODES:' || CASE WHEN rxi_af_subject_forms.startedstate = 0 AND rxi_af_subject_forms.completestate = 0 THEN 'Not Started' WHEN rxi_af_subject_forms.startedstate = 1 AND rxi_af_subject_forms.completestate = 0 THEN 'Started' WHEN rxi_af_subject_forms.startedstate = 1 AND rxi_af_subject_forms.completestate = 1 THEN 'Complete' WHEN rxi_af_subject_forms.startedstate = 0 AND rxi_af_subject_forms.completestate = 1 THEN 'Complete But Unstarted' END AS status_code	-
TA-RCRF03	RXI_CUR_SITE.SITENAME	-
TA-RCRF29	IRV_AF_SUBJECT_FORMS.CASE WHEN IRV_AF_SUBJECT_FORMS.FROZENSTATE = 1 AND FMAXFROZENSTATE IS NOT NULL THEN FMAXFROZENSTATE ELSE NULL;	-
TA-RCRF02	RXI_STUDYVERSIONS.STUDYNAME	-
TA-RCRF08	IRV_AF_SUBJECT_FORMS.VISITINDEX	-
TA-RCRF05	IRV_CUR_SUBJECT.SUBJECTNUMBERSTR	-
TA-RCRF10	IRV_AF_SUBJECT_FORMS.DOV	-
TA-RCRF06	IRV_STUDYVERSION_VISITS .VISITNAME	-
TA-RCRF07	IRV_AF_SUBJECT_FORMS.VISITORDER	-
M-SST04	irv_cur_subject.CASE WHEN irv_cur_subject.subjectstate = 1 THEN 'Screened' WHEN irv_cur_subject.subjectstate = 2 THEN 'Screen Failed' WHEN irv_cur_subject.subjectstate = 3 THEN 'Enroll Failed' WHEN irv_cur_subject.subjectstate = 4 THEN 'Enrolled' WHEN irv_cur_subject.subjectstate = 5 THEN 'Randomized' WHEN irv_cur_subject.subjectstate = 6 THEN 'Complete' WHEN irv_cur_subject.subjectstate = 7 THEN 'Not Complete/Dropped Out' END	-
M-SST06	irv_cur_subject.subjectstate	-
M-SST02	irv_cur_subject.MAXENROLLED	-
M-SST08	IRV_SV_SUBJECT_FORMS.VISITSCHEDULED And VISITCOMPLETE	-
M-SST05	irv_cur_subject.subjectstate	-
M-SST09	sub_event_num need to have the calculation from Two tables IRV_AF_SUBJECT_FORMS IRV_SV_SUBJECTVISITS are joined on "SUBJECTID,VISITID,VISITINDEX,Studyguid" IF (VISITSCHEDULED=1 And VISITCOMPLETE=1 Then sub_event_num=0 ) else if (VISITSCHEDULED=0 And VISITCOMPLETE=1 Then sub_event_num=1 ) Else null End.VISITSCHEDULED And VISITCOMPLETE	-
AD09-75	S_CL_PTCL_LS.OBJECTIVE_DESC	Not sourced from InForm
AD09-76	S_ASSESS. ASSESS_TMPL_NAME	Not sourced from InForm
AD09-77	S_ASSESS. LAST_UPD	Not sourced from InForm
AD09-78	S_ASSESS. NAME	Not sourced from InForm
AD09-79	S_ASSESS.DESC_TEXT	Not sourced from InForm
AD09-81	-	Not sourced from InForm
AD09-82	-	Not sourced from InForm
AD09-83	-	Not sourced from InForm
AD09-84	-	Not sourced from InForm
AD09-85	-	Not sourced from InForm
AD09-86	-	Not sourced from InForm
AD09-87	-	Not sourced from InForm
AD09-88	-	Not sourced from InForm
AD10-78	S_PTCL_SITE_LS. MAX_ENROLLMENT	Not sourced from InForm
AD10-79	S_ASSESS. ASSESS_TMPL_NAME	Not sourced from InForm
AD10-80	S_ASSESS. LAST_UPD	Not sourced from InForm
AD10-81	S_ASSESS. NAME	Not sourced from InForm
AD10-82	S_PTCL_SITE_LS. SDV_TYPE_CD	Not sourced from InForm
AD10-82	S_PTCL_SITE_LS. SDV_TYPE_CD	Not sourced from InForm
AD16-17	S_ASSESS. ASSESS_TMPL_NAME	Not sourced from InForm
AD16-18	S_ASSESS. LAST_UPD	Not sourced from InForm
AD16-19	S_ASSESS. NAME	Not sourced from InForm
AD16-20	S_ASSESS.DESC_TEXT	Not sourced from InForm
AD16-21	S_ASSESS. SCORE	Not sourced from InForm
AD17-48	S_ASSESS. ASSESS_TMPL_NAME	Not sourced from InForm
AD17-49	S_ASSESS. LAST_UPD	Not sourced from InForm
AD17-50	S_ASSESS. NAME	Not sourced from InForm
AD17-51	S_ASSESS.DESC_TEXT	Not sourced from InForm
AD18-13	-	Not sourced from InForm
AD18-14	-	Not sourced from InForm
AD18-15	-	Not sourced from InForm
AD18-16	-	Not sourced from InForm
AD18-17	-	Not sourced from InForm
AD18-18	-	Not sourced from InForm
AD18-19	-	Not sourced from InForm
AD18-20	-	Not sourced from InForm
AD18-21	-	Not sourced from InForm
AD18-22	-	Not sourced from InForm
AD23-01	-	Not sourced from InForm
AD23-02	-	Not sourced from InForm
AD23-03	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from InForm Note: This column is a concatenation of Category + : + Question. For this measure source only the substring before the first ": " If field does not have a ":" or begins with a ":", then use the category "No Category".
AD23-04	-	Not sourced from InForm
AD23-05	-	Not sourced from InForm
AD23-07	-	Not sourced from InForm
M-PRR01	-	Not sourced from InForm
M-PRR02	-	Not sourced from InForm
M-PRR03	-	Not sourced from InForm
M-PRR04	S_ASSESS_VAL .SCORE	Not sourced from InForm
M-PRR05	S_ASSESS_VAL .COMMENTS	Not sourced from InForm
M-PRR06	S_ASSESS_VAL .SEQUENCE_NUM	Not sourced from InForm
M-PRR07	-	Not sourced from InForm
M-PRR08	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from InForm
M-PRR09	-	Not sourced from InForm
M-PRR10	Impact (M-PRR04)	Not sourced from InForm
M-PRR11	S_ASSESS_VAL . WEIGHT	Not sourced from InForm
M-PRR12	Avg of child question scores	Not sourced from InForm
M-PTL01	S_PTCL_VER_LS. AMND_VERSION	Not sourced from InForm
M-PTL02	S_PTCL_VER_LS. VER_CREATED_DT	Not sourced from InForm
M-PTL03	S_PTCL_VER_LS. ORIG_VER_FLG	Not sourced from InForm
M-PTL04	-	Not sourced from InForm
M-PTL05	-	Not sourced from InForm
M-PTL06	S_PTCL_VER_LS. COMMENTS	Not sourced from InForm
M-SDR01	-	Not sourced from InForm
M-SDR02	-	Not sourced from InForm
M-SDR03	-	Not sourced from InForm
M-SDR04	S_ASSESS_VAL . SCORE	Not sourced from InForm
M-SDR05	S_ASSESS_VAL .COMMENTS	Not sourced from InForm
M-SDR06	S_ASSESS_VAL .SEQUENCE_NUM	Not sourced from InForm
M-SDR07	-	Not sourced from InForm
M-SDR08	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from InForm
M-SDR09	-	Not sourced from InForm
M-SDR10	Impact (M-SDR04)	Not sourced from InForm
M-SDR11	S_ASSESS_VAL . WEIGHT	Not sourced from InForm
M-SDR12	Avg of child question scores	Not sourced from InForm
M-SRG36	S_CL_PTCL_LS.INIT_NUM_OF_SUBJ	Not sourced from InForm
M-SRG37	S_CL_PTCL_LS. SEL_CL_SUBJ_PCT	Not sourced from InForm
M-SRR01	-	Not sourced from InForm
M-SRR02	-	Not sourced from InForm
M-SRR03	-	Not sourced from InForm
M-SRR04	S_ASSESS_VAL . SCORE	Not sourced from InForm
M-SRR05	S_ASSESS_VAL .COMMENTS	Not sourced from InForm
M-SRR06	S_ASSESS_VAL .SEQUENCE_NUM	Not sourced from InForm
M-SRR07	-	Not sourced from InForm
M-SRR08	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from InForm
M-SRR09	-	Not sourced from InForm
M-SRR10	Impact (M-SRR04)	Not sourced from InForm
M-SRR11	S_ASSESS_VAL . WEIGHT	Not sourced from InForm
M-SRR12	Avg of child question scores	Not sourced from InForm
M-SSR01	-	Not sourced from InForm
M-SSR02	-	Not sourced from InForm
M-SSR03	-	Not sourced from InForm
M-SSR04	S_ASSESS_VAL . SCORE	Not sourced from InForm
M-SSR05	S_ASSESS_VAL .COMMENTS	Not sourced from InForm
M-SSR06	S_ASSESS_VAL .SEQUENCE_NUM	Not sourced from InForm
M-SSR07	-	Not sourced from InForm
M-SSR08	S_ASSESS_VAL . ATTRIB_NAME	Not sourced from InForm
M-SSR09	-	Not sourced from InForm
M-SSR10	Impact (M-SSR04)	Not sourced from InForm
M-SSR11	S_ASSESS_VAL . WEIGHT	Not sourced from InForm
M-SSR12	Avg of child question scores	Not sourced from InForm
M-SST107	S_PTCL_SITE_LS.INIT_NUM_OF_SUBJ	Not sourced from InForm
M-SST108	S_PTCL_SITE_LS. SEL_CL_SUBJ_PCT	Not sourced from InForm
M-STD100	-	Not sourced from InForm
M-STD101	-	Not sourced from InForm
M-STD102	-	Not sourced from InForm
M-STD103	-	Not sourced from InForm
M-STD104	-	Not sourced from InForm
M-STD105	-	Not sourced from InForm
M-STD106	-	Not sourced from InForm
M-STD107	-	Not sourced from InForm
M-STD108	-	Not sourced from InForm
M-STD109	-	Not sourced from InForm
M-STD110	-	Not sourced from InForm
M-STD111	-	Not sourced from InForm
M-STD112	-	Not sourced from InForm
M-STD113	-	Not sourced from InForm
M-STD114	-	Not sourced from InForm Count of all versions of a protocol that are not the original version that have been flagged as avoidable.
M-STD115	S_CL_PTCL_LS.INIT_NUM_OF_SUBJ	Not sourced from InForm
M-STD116	S_CL_PTCL_LS.SEL_CL_SUBJ_PCT	Not sourced from InForm
M-STD93	-	Not sourced from InForm
M-STD94	-	Not sourced from InForm
M-STD95	-	Not sourced from InForm
M-STD96	-	Not sourced from InForm
M-STD97	-	Not sourced from InForm
M-STD98	-	Not sourced from InForm
M-STD99	-	Not sourced from InForm
TA-SIV12	S_EVT_ACT_LSX. REVIEWED_TS	Not sourced from InForm
TA-SIV13	S_EVT_ACT_LSX. REVIEW_COMMENTS	Not sourced from InForm
TA-SIV14	Employee Last, First Name; Join on S_EVT_ACT_LSX. REVIEWER_ID	Not sourced from InForm
TA-SIV15	Employee Last, First Name; Join on S_EVT_ACT_LSX. APPROVER_ID	Not sourced from InForm
TA-SUBJ10	S_CL_SUBJ_LS.	Not sourced from InForm
TA-SUBJ11	S_CL_SUBJ_LS .SDV_UPD_TYPE_CD	Not sourced from InForm