| Oracle® Clinical Development Analytics User and Administrator Guide Release 2.0.0.2 Part Number E18162-03 |
|
|
View PDF |
| Oracle® Clinical Development Analytics User and Administrator Guide Release 2.0.0.2 Part Number E18162-03 |
|
|
View PDF |
The OCDA Presentation Catalog displays columns that you can use to create requests.
This appendix contains the following topics:
See Also:
Chapter 3, Working with Reports
Table B-1 describes the Dimensions displayed in the OCDA 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 |
|---|---|---|---|
|
AD2 |
Date |
Date |
Attributes of a date |
|
AD02-02 |
Date |
Julian Day |
Julian Day |
|
AD02-03 |
Date |
Month |
Month within calendar year |
|
AD02-04 |
Date |
Quarter |
Quarter within calendar year |
|
AD02-05 |
Date |
Year |
Calendar year |
|
AD02-06 |
Date |
Week |
Week within calendar year |
|
AD02-07 |
Date |
Date |
Calendar Date |
|
AD02-08 |
Date |
Julian Month |
Julian Month |
|
AD02-09 |
Date |
Julian Week |
Julian Week |
|
AD02-10 |
Date |
Month Name |
Full name of the month |
|
AD02-11 |
Date |
Year and Month |
Year and month (For example, 1994 / 02) |
|
AD02-12 |
Date |
Year and Week |
Year and week (For example, 1994 Week10) |
|
AD02-13 |
Date |
Year and Quarter |
Year and quarter (For example, 1994 Q1) |
|
AD4 |
Geography |
Geography |
Location of a site, in terms of a fixed hierarchy. State >- Country >- Continent. |
|
AD04-01 |
Geography |
Continent |
Continent |
|
AD04-03 |
Geography |
Country |
Country |
|
AD04-04 |
Geography |
State or Province |
State or Province |
|
AD04-05 |
Geography |
County or District |
County or District |
|
AD04-06 |
Geography |
City |
City |
|
AD04-07 |
Geography |
Postal Code |
Zip or Postal Code |
|
AD5 |
Investigator |
Investigator |
Attributes of an Investigator, who may participate in multiple studies. |
|
AD05-01 |
Investigator |
Investigator Last Name |
Investigator's surname |
|
AD05-02 |
Investigator |
Investigator First Name |
Investigator's given name |
|
AD05-03 |
Investigator |
Investigator Full Name |
First name, then last name |
|
AD05-04 |
Investigator |
Investigator Street Address |
Investigator's street address |
|
AD05-05 |
Investigator |
Investigator City |
The city where the investigator is located. |
|
AD05-06 |
Investigator |
Investigator Postal code |
Postal or zip code |
|
AD05-07 |
Investigator |
Investigator State |
The state where the investigator is located |
|
AD05-08 |
Investigator |
Investigator Country |
Country where the investigator is located |
|
AD05-09 |
Investigator |
Investigator Continent |
Continent where the investigator is located |
|
AD05-10 |
Investigator |
Investigator Work Phone |
Investigator's work telephone |
|
AD05-11 |
Investigator |
Investigator Business Unit |
Organizational business unit |
|
AD05-12 |
Investigator |
Investigator Mobile # |
Investigator mobile number |
|
AD05-13 |
Investigator |
Investigator Email Address |
Investigator email address |
|
AD05-14 |
Investigator |
Investigator Fax/Phone # |
Investigator fax/phone number |
|
AD05-15 |
Investigator |
Investigator Middle Name |
Investigator middle name |
|
AD05-16 |
Investigator |
Investigator Type |
Investigator type |
|
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 |
|
AD05-19 |
Investigator |
Investigator Action Link |
ROW_ID for the Siebel Clinical Contact table. You can use it in Siebel Clinical for an Action Link. |
|
AD7 |
Product |
Product |
Product dimension |
|
AD07-01 |
Product |
Product Name |
Name of the product |
|
AD07-02 |
Product |
Product Type |
Type of the product |
|
AD07-03 |
Product |
Product Type Code |
Organization's type code for the product |
|
AD07-04 |
Product |
Description |
Product Description |
|
AD07-07 |
Product |
Product Number |
Product # |
|
AD07-08 |
Product |
Product Status |
Product Status |
|
AD07-09 |
Product |
Product Action Link |
ROW_ID for the Siebel Clinical Product table. You can use it in Siebel Clinical for an Action Link. |
|
AD8 |
Site |
Site |
A physical setting at which one or more studies may be conducted. |
|
AD08-01 |
Site |
Site Name |
Name of the Site |
|
AD08-02 |
Site |
State |
State in which the Site is located |
|
AD08-03 |
Site |
Country |
Country in which the Site is located |
|
AD08-04 |
Site |
Continent |
Continent in which the Site is located |
|
AD08-05 |
Site |
Business Unit |
Business Unit within Site organization. Part of unique key for SC Site |
|
AD08-06 |
Site |
Site Action Link |
ROW_ID for the Siebel Clinical Account table. You can use it in Siebel Clinical for an Action Link. |
|
AD9 |
Study |
Study |
A description of the study |
|
AD09-01 |
Study |
Study |
Unique identifier for the Study |
|
AD09-02 |
Study |
Study Short Title |
A unique short title for the Study |
|
AD09-03 |
Study |
Program |
Name of the Program that owns the Study |
|
AD09-04 |
Study |
Project |
OC Project containing the Study |
|
AD09-05 |
Study |
Study Sponsor |
Name of the Sponsor company for which this study is being conducted |
|
AD09-06 |
Study |
Data Capture Mode |
The mode of doing data entry in this study. Possible values are {'EDC' | 'Paper' | 'Paper and EDC' | 'Unknown'} |
|
AD09-07 |
Study |
Comparative Agent |
Comparative Agent |
|
AD09-08 |
Study |
Diagnosis |
Diagnosis |
|
AD09-09 |
Study |
EUDRA Number |
EUDRA Number |
|
AD09-10 |
Study |
Study Phase |
Phase |
|
AD09-11 |
Study |
Study Status |
Protocol Status |
|
AD09-12 |
Study |
Study Title |
Title |
|
AD09-13 |
Study |
Study Type |
Type |
|
AD09-14 |
Study |
Database Lock Date |
Database lock date |
|
AD09-15 |
Study |
Study Action Link |
ROW_ID for the Siebel Clinical Study table. You can use it in Siebel Clinical for an Action Link. |
|
AD10 |
Study-Site |
Study-Site |
The use of a site for a study |
|
AD10-01 |
Study-Site |
Site Name |
Name of the Site being used for this Study Site. |
|
AD10-02 |
Study-Site |
Study-Site ID # |
Unique name given the site in the context of the Study. |
|
AD10-03 |
Study-Site |
Study Region |
Name of the study-specific region in which the study site is located |
|
AD10-04 |
Study-Site |
Study |
Unique identifier 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 |
|
AD10-07 |
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. |
|
AD10-08 |
Study-Site |
Planned Enrollment Completion Date |
Date on which enrollment is (or was) planned to be complete |
|
AD10-10 |
Study-Site |
First Subject Enrolled Date |
Date on which first subject was enrolled at the study-site. |
|
AD10-22 |
Study-Site |
Principal Investigator |
Full name of Investigator currently responsible for the study at the 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'} |
|
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 |
|
AD10-29 |
Study-Site |
Study-Site Status |
Site Status |
|
AD10-31 |
Study-Site |
County |
Site Country |
|
AD10-32 |
Study-Site |
City |
Site City |
|
AD10-33 |
Study-Site |
Postal Code |
Site Postal Code |
|
AD10-34 |
Study-Site |
Street Address |
Study-site Street Address line 1 |
|
AD10-35 |
Study-Site |
Street Address 2 |
Study-site Street Address line 2 |
|
AD10-36 |
Study-Site |
Street Address 3 |
Study-site Street Address line 3 |
|
AD10-37 |
Study-Site |
Study, Site, & Investigator |
Concatenation of Study #, Site #, and Principal Investigator Last Name |
|
AD10-38 |
Study-Site |
Study Region Status |
Status of the Study Region (denormalized from Study.Region Status) |
|
AD10-39 |
Study-Site |
Study-Site Action Link |
ROW_ID for the Siebel Clinical Study Site table. You can use it in Siebel Clinical for an Action Link. |
|
AD10-40 |
Study-Site |
Study Status |
Status of the Study (denormalized from Study.Status) |
|
AD11 |
CRF |
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. |
|
AD11-01 |
CRF |
Study |
Study in which the form is specified. |
|
AD11-02 |
CRF |
CRF Name |
Name of the form. |
|
AD11-03 |
CRF |
Description |
Free text description of the particular CRF |
|
AD11-04 |
CRF |
CRF Short Name |
Short name of the form |
|
AD11-05 |
CRF |
DCI_ID |
Oracle Clinical ID for the form. |
|
AD12 |
CRF Book |
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 |
|
AD13 |
Validation Procedure |
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. |
|
AD13-02 |
Validation Procedure |
Validation Procedure Name |
Name of the Validation Procedure |
|
AD13-03 |
Validation Procedure |
Validation Procedure Description |
Description 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 |
|
AD14 |
Study-Site Team Member |
Study-Site Team Member |
- |
|
AD14-01 |
Study-Site Team Member |
First Name |
Team member first name |
|
AD14-02 |
Study-Site Team Member |
Last Name |
Team member last name |
|
AD14-03 |
Study-Site Team Member |
Full Name |
Last Name, First 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 |
|
AD14-06 |
Study-Site Team Member |
End Date |
End Date in the Team History view |
|
AD14-07 |
Study-Site Team Member |
Team Member Comment |
Comment in the Team History view |
|
AD14-08 |
Study-Site Team Member |
Team Member Action Link |
ROW_ID for the Siebel Clinical Employee table. You can use it in Siebel Clinical for an Action Link. |
|
AD15 |
Study-Site Contacts |
Study-Site Contacts |
- |
|
AD15-01 |
Study-Site Contacts |
City |
Study-Site contact city |
|
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 |
|
AD15-19 |
Study-Site Contacts |
Contact Action Link |
ROW_ID for the Siebel Clinical Contact table. You can use it in Siebel Clinical for an Action Link. |
|
AD16 |
Program |
Program |
Program |
|
AD16-01 |
Program |
Program Description |
Program Description |
|
AD16-02 |
Program |
Program |
Program Name |
|
AD16-03 |
Program |
Program Mechanism |
Program Mechanism |
|
AD16-04 |
Program |
Program Action Link |
ROW_ID for the Siebel Clinical Program table. You can use it in Siebel Clinical for an Action Link. |
|
AD17 |
Region |
Region |
Study Region |
|
AD17-01 |
Region |
Region Name |
Study Region Name |
|
AD17-02 |
Region |
Region Status |
Status of Study Region |
|
AD17-03 |
Region |
Region CRO |
CRO for a Study Region |
|
AD17-04 |
Region |
Region Action Link |
ROW_ID for the Siebel Clinical Region table. You can use it in Siebel Clinical for an Action Link. |
|
TD1 |
Subject |
Subject |
A person taking part in a study. While a person may participate in multiple studies, each participation corresponds to a unique subject |
|
TD01-01 |
Subject |
Study |
Name of the clinical study in which this subject is a participant |
|
TD01-02 |
Subject |
Subject ID |
A unique code for the patient position within the clinical study. |
|
TD01-03 |
Subject |
CRF Book |
The ID of the DCI book to be used for this patient. |
|
TD01-04 |
Subject |
Is Hard Locked |
A flag to show if the system prevents any changes to the data for this patient. |
|
TD01-05 |
Subject |
Is Early Terminated |
A flag to show if the patient was terminated early from the study. VARCHAR2(1) |
|
TD01-06 |
Subject |
Enrollment date |
Date and time when this patient was enrolled in this study. |
|
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'. |
|
TD01-08 |
Subject |
Subject Initials |
The patient's initials, in mixed case. |
|
TD01-09 |
Subject |
Birth Date |
The patients date of birth. |
|
TD01-10 |
Subject |
Death Date |
The date that the patient was reported to have died. |
|
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. |
|
TD01-16 |
Subject |
Gender |
The patient's gender. Values are M for male and F for female. |
|
TD01-17 |
Subject |
Screening date |
Date on which subject passed screening. |
|
TD01-18 |
Subject |
Eligible Flag |
Subject Eligible Flag |
|
TD01-19 |
Subject |
Subject Comments |
Subject comment |
|
TD01-20 |
Subject |
Enrollment ID |
Enrollment ID |
|
TD01-21 |
Subject |
Randomization ID |
Randomization ID |
|
TD01-22 |
Subject |
Protocol Violation Flag |
Subject Protocol Violation Flag |
|
TD01-23 |
Subject |
Screen Failure Reason |
Screen Failure Reason |
|
TD01-24 |
Subject |
Screening # |
Screening # |
|
TD01-25 |
Subject |
Protocol Deviation Flag |
Subject Protocol Deviation Flag |
|
TD01-26 |
Subject |
Withdrawn Reason |
Withdrawn reason |
|
TD01-27 |
Subject |
Subject Age |
Current date minus subject Birth Date |
|
TD01-28 |
Subject |
Subject Current Status Date |
Date of subject's current status |
|
TD01-29 |
Subject |
Randomization Date |
Date on which the Subject was randomized |
|
TD01-30 |
Subject |
Subject Action Link |
ROW_ID for the Siebel Clinical Subject table. You can use it in Siebel Clinical for an Action Link. |
Table B-2 describes the Facts displayed in the OCDA 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-DOC01 |
Document Metrics |
Counts |
# of Documents |
Count of all Activities where Activity is Document or Site-Initiation |
|
M-DRS01 |
Discrepancy Review Statuses |
Transactional Data |
Discrepancy Review Status |
A review status occupied by a discrepancy over the life of the discrepancy. |
|
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-DSC01 |
Discrepancies |
Counts |
# Total Discrepancies |
Number of discrepancies, both open and closed |
|
M-DSC02 |
Discrepancies |
Counts |
# Open Discrepancies |
Number of discrepancies awaiting either being resolved or being marked irresolvable. |
|
M-DSC03 |
Discrepancies |
Counts |
# Closed Discrepancies |
Number of discrepancies that have either been obsolete or 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-DSC09 |
Discrepancies |
Counts |
# Discrepancies Irresolvable |
Number of discrepancies that have been marked irresolvable |
|
M-DSC11 |
Discrepancies |
Transactional Data |
# Days Discrepancy Open |
For those discrepancies that have been closed: Discrepancy close date - Discrepancy creation date; For currently open discrepancies: last ETL date - Discrepancy creation date. |
|
M-DSC12 |
Discrepancies |
Counts |
# Days Current Discrepancies Open |
For currently open discrepancies, number of days since creation. |
|
M-DSC15 |
Discrepancies |
Counts |
# Days to Close Discrepancy |
NULL if open; Days from creation of discrepancy to: date closed, if discrepancy closed |
|
M-RCF01 |
Received CRFs |
Counts |
# CRFs Entry Complete |
Total number of CRFs for which entry has been completed |
|
M-RCF05 |
Received CRFs |
Counts |
# pCRFs Received, Not Entered |
Number of pCRFs at Received |
|
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-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-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-RCF10 |
Received CRFs |
Counts |
# CRFs Present |
Count of Present CRFs. |
|
M-RCF11 |
Received CRFs |
Intervals |
# Days pCRF Awaiting Pass 1 Entry |
Number of days pCRF received inhouse, awaiting first entry, to today's date |
|
M-RCF13 |
Received CRFs |
Counts |
# pCRFs Pass 2 Entry Started, but Incomplete |
Number of pCRFs at Pass 2 Started or Pass 2 Pending |
|
M-RCF14 |
Received CRFs |
Counts |
# pCRFs Pass 2 Entry Complete |
Number of pCRFs completed second entry |
|
M-RCF15 |
Received CRFs |
Counts |
# pCRFs Awaiting Double Entry Reconciliation |
Number of pCRFs awaiting double-entry reconciliation |
|
M-RCF16 |
Received CRFs |
Counts |
# pCRFs Awaiting Pass 2 Entry Completion |
Number of pCRFs awaiting completion of second data entry |
|
M-RCF17 |
Received CRFs |
Counts |
# pCRFs Awaiting Entry Completion |
Number of pCRFs awaiting completion of either first or second data entry |
|
M-RCF18 |
Received CRFs |
Counts |
# CRFs Awaiting Entry Completion |
Count of CRFs that meet the criteria for Incomplete |
|
M-RCF19 |
Received CRFs |
Counts |
# CRFs Electronically Loaded |
Number of CRFs that were electronically, i.e. batch, loaded |
|
M-RCF20 |
Received CRFs |
Counts |
# eCRFs Verified |
Number of eCRFs which have been source-data verified by the CRA/Monitor |
|
M-RCF21 |
Received CRFs |
Counts |
# eCRFs in Not Verified State |
Number of eCRFs that are not in a verified state? |
|
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-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-RCF23 |
Received CRFs |
Counts |
# eCRFs Never Verified |
Number of eCRFs that have never been verified |
|
M-RCF24 |
Received CRFs |
Counts |
# eCRFs Approved |
Number of eCRFs which have been approved by Investigator |
|
M-RCF25 |
Received CRFs |
Counts |
# eCRFs Not Approved |
Number of eCRFs which require initial Approval by Investigator |
|
M-RCF26 |
Received CRFs |
Counts |
# eCRFs Awaiting Re-Approval |
Number of eCRFs requiring Re-Approval by Investigator |
|
M-RCF29 |
Received CRFs |
Counts |
# CRFs Soft Locked |
Number of Soft Locked CRFs |
|
M-RCF29.1 |
Received CRFs |
Counts |
# CRFs Hard Locked |
Number of Hard Locked CRFs |
|
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-RCF31 |
Received CRFs |
Intervals |
# Days from pCRF Visit to Pass 1 Entry |
Interval between pCRF visit date and date of first 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-RCF32 |
Received CRFs |
Intervals |
# Days from pCRF Pass 1 Entry to Pass 2 Entry Complete |
Interval between pCRF first entry and second entry |
|
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-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-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-RCF37 |
Received CRFs |
Intervals |
# Days from CRF Entry Complete to Soft Locked |
Interval between CRF Entry Complete and Soft Locked |
|
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-RCF39 |
Received CRFs |
Intervals |
# Days from eCRF Visit to eCRF Complete |
# Days from date of eCRF Visit to Date when entry complete |
|
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-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-RCF42 |
Received CRFs |
Statistics |
Avg # Days from pCRF Visit to First Entry |
Average interval between pCRF visit date and date of first entry |
|
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-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 |
|
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-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-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-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-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-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-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-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-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-RCF52 |
Received CRFs |
Ratios |
% eCRFs Verified / Present |
%# eCRFs Verified /# eCRFs Present |
|
M-RCF52.1 |
Received CRFs |
Ratios |
% eCRFs Approved / Present |
%# eCRFs Verified /# eCRFs Entry Complete |
|
M-RCF55.1 |
Received CRFs |
Ratios |
% eCRFs Approved / Entry Complete |
%#eCRFs Approved /# eCRFs Entry Complete |
|
M-RCF55.2 |
Received CRFs |
Ratios |
% eCRFs Verified / Entry Complete |
%#eCRFs Verified /# eCRFs Entry Complete |
|
M-RCF58 |
Received CRFs |
Ratios |
% eCRFs Soft Locked / Present |
%# eCRFs Soft Locked /# eCRFs Present |
|
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-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-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-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-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-RCF64.1 |
Received CRFs |
Ratios |
% Soft Locked / Present |
% CRF Soft Locked/#CRFs Present |
|
M-RCF64.2 |
Received CRFs |
Ratios |
% Hard Locked / Entry Complete |
100 *# CRFs Hard Locked/# CRFs Entry Complete |
|
M-RCF64.3 |
Received CRFs |
Ratios |
% eCRFs Hard Locked / Entry Complete |
100 *# eCRFs Hard Locked/# CRFs Entry Complete |
|
M-RCF64.4 |
Received CRFs |
Ratios |
% pCRFs Hard Locked / Entry Complete |
100 *# pCRFs Hard Locked/# CRFs Entry Complete |
|
M-RCF65 |
Received CRFs |
Ratios |
% Processed / Present |
% CRF completely entered /#CRFs Present |
|
M-RCF68 |
Received CRFs |
Counts |
# eCRFs Entry Complete |
Total number of eCRFs for which entry has been completed |
|
M-RCF69 |
Received CRFs |
Counts |
# eCRFs Initially Verified |
Total number of eCRFs that were verified at least once |
|
M-RCF70 |
Received CRFs |
Counts |
# eCRFs Initially Approved |
Total number of eCRFs there were approved at least once |
|
M-RCF71 |
Received CRFs |
Counts |
# eCRFs Finally Approved |
Total number of eCRFs that were finally approved |
|
M-RCF71.1 |
Received CRFs |
Counts |
# eCRFs Hard Locked |
Total # of Hard Locked eCRFs |
|
M-RCF72 |
Received CRFs |
Counts |
# eCRFs Soft Locked |
Total number of Soft Locked eCRFs |
|
M-RCF73 |
Received CRFs |
Counts |
# pCRFs Awaiting Pass 2 Entry |
Total number of pCRFs Awaiting Pass 2 Entry |
|
M-RCF74 |
Received CRFs |
Counts |
# pCRFs Soft Locked |
Total # of Soft Locked pCRFs |
|
M-RCF74.1 |
Received CRFs |
Counts |
# pCRFs Hard Locked |
Total # of Hard Locked pCRFs |
|
M-RCF75 |
Received CRFs |
Counts |
# eCRFs Present |
Total # of Present # eCRFs |
|
M-RCF76 |
Received CRFs |
Intervals |
# Days from pCRF Entry Complete to Soft Locked |
Total # Days from pCRF Entry Complete to Soft Locked |
|
M-RCF77 |
Received CRFs |
Statistics |
Avg # of Days pCRF Awaiting First Entry |
Average # of Days pCRF Awaiting First Entry |
|
M-RCF78 |
Received CRFs |
Counts |
# pCRFs Entry Complete |
Total number of pCRFs for which entry has been completed |
|
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-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-RCF83 |
Received CRFs |
Counts |
# pCRFs Present |
Count of Present pCRFs |
|
M-RCF84 |
Received CRFs |
Counts |
# eCRFs Unplanned |
Number of eCRFs that are Present but collected at an unplanned event |
|
M-RCF85 |
Received CRFs |
Counts |
# pCRFs Unplanned |
Number of pCRFs that are Present but collected at an unplanned event |
|
M-RCF86 |
Received CRFs |
Counts |
# eCRFs Awaiting Entry Completion |
Count of eCRFs that meet the criteria for Incomplete |
|
M-REG01 |
Region Metrics |
Counts |
# Study-Sites Planned for Region |
# Planned Sites |
|
M-REG02 |
Region Metrics |
Counts |
# Subjects Planned for Region |
# Planned Subjects |
|
M-SST01 |
Study-site Metrics |
Counts |
# Subjects Planned |
Total number of subjects planned to be enrolled at the Study-Site |
|
M-SST02 |
Study-site Metrics |
Counts |
# Subjects Enrolled |
Number of subjects who ever have had status Enrolled |
|
M-SST02C |
Study-site Metrics |
Counts |
# Subjects - Current Status Enrolled |
Number of subjects with a current status of Enrolled |
|
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-SST04 |
Study-site Metrics |
Counts |
# Current Active Subjects |
Total number of Patients currently conducting Study |
|
M-SST05 |
Study-site Metrics |
Counts |
# Subjects who have completed Study |
Number of subjects who ever have had status Completed |
|
M-SST05C |
Study-site Metrics |
Counts |
# Subjects - Current Status Completed |
Number of subjects whose current status is Completed |
|
M-SST06 |
Study-site Metrics |
Counts |
# Early Terminations |
Number of subjects who ever have had status Early Terminated |
|
M-SST06C |
Study-site Metrics |
Counts |
# Subjects - Current Status Early Terminated |
Number of subjects whose current status is Early Terminated |
|
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-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-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-SST17 |
Study-site Metrics |
Ratios |
Open Discrepancies per CRF |
Number of Open Discrepancies per CRF currently Present |
|
M-SST18 |
Study-site Metrics |
Ratios |
Total Discrepancies per CRF |
Number of all Discrepancies (Open or Closed) per CRF currently Present |
|
M-SST19 |
Study-site Metrics |
Ratios |
Closed Discrepancies per CRF |
Number of Closed 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-SST21 |
Study-site Metrics |
Ratios |
Total Discrepancies per Enrolled Subject |
Number of all Discrepancies (Open or Closed) per currently enrolled Subject |
|
M-SST23 |
Study-site Metrics |
Ratios |
Closed Discrepancies per Enrolled Subject |
Number of closed discrepancies per currently enrolled Subject |
|
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 |
|
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-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-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-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-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-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-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-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-SST32 |
Study-Site Metrics |
Counts |
# Randomized |
Subjects who ever have had status Randomized. |
|
M-SST32C |
Study-Site Metrics |
Counts |
# Subjects - Current Status Randomized |
Number of subjects whose current status is Randomized |
|
M-SST33 |
Study-Site Metrics |
Counts |
# Re-Screened |
Subjects who ever have had status Re-Screened |
|
M-SST33C |
Study-Site Metrics |
Counts |
# Subjects - Current Status Re-Screened |
Number of subjects whose current status is Re-Screened |
|
M-SST34 |
Study-Site Metrics |
Counts |
# Screen Failure |
Subjects who ever have had status Screen Failure |
|
M-SST34C |
Study-Site Metrics |
Counts |
# Subjects - Current Status Screen Failure |
Number of subjects whose current status is Screen Failure |
|
M-SST35 |
Study-Site Metrics |
Counts |
# Screened |
Subjects who ever have had status Screened |
|
M-SST35C |
Study-Site Metrics |
Counts |
# Subjects - Current Status Screened |
Number of subjects whose current status is Screened |
|
M-SST36 |
Study-Site Metrics |
Counts |
# Subjects |
Count of the number of subject records returned |
|
M-SST37 |
Study-Site Metrics |
Counts |
# Subjects Deviation |
Number of subjects with the Protocol Deviation flag checked |
|
M-SST38 |
Study-Site Metrics |
Counts |
# Subjects Violation |
Number of subjects with the Protocol Violation flag checked |
|
M-SST39 |
Study-site Metrics |
Counts |
Days Since Initiation |
Number of days from current date to Site Initiation Date |
|
M-SST40 |
Study-Site Metrics |
Statistics |
First Subject Withdrawn Date |
Earliest date on which a subject withdrew (Status is Early Terminated) from the study |
|
M-SST41 |
Study-Site Metrics |
Statistics |
First Subject Completed Date |
Earliest date on which a subject completed the study |
|
M-SST42 |
Study-Site Metrics |
Statistics |
First Subject Enrolled Date |
First Subject Enrolled |
|
M-SST43 |
Study-Site Metrics |
Statistics |
First Subject Randomized Date |
First Subject Randomized |
|
M-SST44 |
Study-Site Metrics |
Statistics |
First Subject Screened Date |
First Subject Screened |
|
M-SST45 |
Study-Site Metrics |
Statistics |
Latest Subject Completed Date |
Most recent date on which a subject completed the study |
|
M-SST46 |
Study-Site Metrics |
Statistics |
Latest Subject Enrolled Date |
Most recent date on which a subject enrolled in the study |
|
M-SST47 |
Study-Site Metrics |
Statistics |
Latest Subject Randomized Date |
Most recent date on which a subject was randomized |
|
M-SST48 |
Study-Site Metrics |
Statistics |
Latest Subject Screened Date |
Most recent date on which a subject was screened |
|
M-SST49 |
Study Metrics |
Counts |
# Sites with 1 or More Subjects Screened |
Number of study-sites with 1 or more subjects screened |
|
M-SST50 |
Document Metrics |
Counts |
# Days from Document Sent to Document Received |
Number of days between Document Sent date and Document Received Date |
|
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-SST52 |
Study-site Metrics |
Intervals |
# Days Since Last Enrolllment for Study-site |
Number of days between today's date and the most recent enrollment date at the study-site |
|
M-SST53 |
Study-site Metrics |
Ratios |
% of Planned Site Enrollment Completed |
The number of subjects enrolled at study-site divided by the number of subjects planned at 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-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-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-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-STD01 |
Study Metrics |
Counts |
# Planned Sites |
Number of sites planned to execute the study |
|
M-STD02 |
Study Metrics |
Counts |
# Enrollments Planned for Study |
Total number of subjects planned to be enrolled for the Study |
|
M-STD06 |
Study Metrics |
Ratios |
% Enrolled / Planned in Study |
Ratio of number of enrolled subjects to total planned number of subjects for the study |
|
M-STD07 |
Study Metrics |
Counts |
# Study-Sites |
# of protocol sites created for 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 |
|
TA-DISC01 |
Discrepancies |
Transactional Data |
Discrepancy ID |
Unique ID of the discrepancy |
|
TA-DISC02 |
Discrepancies |
Transactional Data |
Study |
Study in which the discrepancy was created |
|
TA-DISC03 |
Discrepancies |
Transactional Data |
Site |
Site at which the discrepancy was created |
|
TA-DISC04 |
Discrepancies |
Transactional Data |
Investigator |
Study-site Investigator |
|
TA-DISC05 |
Discrepancies |
Transactional Data |
Subject |
Patient ID for the patient about whom the data were collected. |
|
TA-DISC06 |
Discrepancies |
Transactional Data |
Visit Name |
Name of the visit at which the value causing the discrepancy was collected |
|
TA-DISC07 |
Discrepancies |
Transactional Data |
Visit Number |
Number of the visit at which the value causing the discrepancy was collected |
|
TA-DISC08 |
Discrepancies |
Transactional Data |
Sub-event Number |
Sub-event number of the visit at which the value causing the discrepancy was collected |
|
TA-DISC09 |
Discrepancies |
Transactional Data |
Complete Visit Number |
Planned event number || . || subevent number |
|
TA-DISC10 |
Discrepancies |
Transactional Data |
Visit Date |
Date of the visit when the value causing the discrepancy was collected |
|
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-DISC13 |
Discrepancies |
Transactional Data |
CRF Book Page |
Page within subject's CRF book where the question giving rise to the discrepancy is located |
|
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-DISC19 |
Discrepancies |
Transactional Data |
Irresolvable? |
Y' if the discrepancy has been marked as irresolvable; 'N' otherwise. |
|
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. |
|
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-DISC22 |
Discrepancies |
Transactional Data |
Status |
OC Discrepancy Status. Takes value of CURRENT, OBSOLETE |
|
TA-DISC22.1 |
Discrepancies |
Transactional Data |
Discrepancy State |
'Open', 'Answered', 'Closed', possibly others. |
|
TA-DISC23 |
Discrepancies |
Transactional Data |
Type |
How the discrepancy came into existence: Values are UNIVARIATE, MULTIVARIATE, MANUAL, and INDICATOR |
|
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-DISC25 |
Discrepancies |
Transactional Data |
Creation Date |
Date when the discrepancy was created |
|
TA-DISC26 |
Discrepancies |
Transactional Data |
Close Date |
Date when the discrepancy was closed (i.e. closed, made obsolete, or marked irresolvable). |
|
TA-DISC26.1 |
Discrepancies |
Transactional Data |
Answered Date |
Date when a query about the discrepancy was answered |
|
TA-DISC30 |
Discrepancies |
Transactional Data |
Comment Text |
Text associated with the discrepancy |
|
TA-DISC31 |
Discrepancies |
Transactional Data |
Sent in DCF |
Flag to indicate whether a discrepancy was sent in DCF |
|
TA-DISC32 |
Discrepancies |
Transactional Data |
Origin |
The origin of the discrepancy. Takes one of these values: {System; Non-system} |
|
TA-DISC33 |
Discrepancies |
Transactional Data |
Study-site |
Name of the Study-site at which the discrepancy was created |
|
TA-DOC01 |
Document Metrics |
Transactional Data |
Activity |
Document Activity |
|
TA-DOC02 |
Document Metrics |
Transactional Data |
Document Comments |
Document Comments |
|
TA-DOC03 |
Document Metrics |
Transactional Data |
Document Name |
Document Name |
|
TA-DOC04 |
Document Metrics |
Transactional Data |
Activity Type |
Activity Type |
|
TA-DOC05 |
Document Metrics |
Transactional Data |
Document Expected Date |
Document Expected Date |
|
TA-DOC06 |
Document Metrics |
Transactional Data |
Document Received Date |
Document Received Date |
|
TA-DOC07 |
Document Metrics |
Transactional Data |
Document Sent Date |
Document Sent Date |
|
TA-DOC08 |
Document Metrics |
Transactional Data |
Document Expiration Date |
Document Expiration Date |
|
TA-RCRF01 |
Received CRFs |
Transactional Data |
Document ID |
External identifier for the CRF |
|
TA-RCRF02 |
Received CRFs |
Transactional Data |
Study |
Study in which the CRF was created |
|
TA-RCRF03 |
Received CRFs |
Transactional Data |
Site |
Site at which the CRF was created |
|
TA-RCRF04 |
Received CRFs |
Transactional Data |
Investigator |
Study-site Investigator |
|
TA-RCRF05 |
Received CRFs |
Transactional Data |
Subject |
Patient ID for the patient about whom the data were collected. |
|
TA-RCRF06 |
Received CRFs |
Transactional Data |
Visit Name |
Name of the visit at which the CRF was collected |
|
TA-RCRF07 |
Received CRFs |
Transactional Data |
Visit Number |
Number of the visit at which CRF was collected |
|
TA-RCRF08 |
Received CRFs |
Transactional Data |
Sub-event Number |
Sub-event number of the visit at which the CRF was collected |
|
TA-RCRF09 |
Received CRFs |
Transactional Data |
Complete Visit Number |
Planned event number || . || subevent number |
|
TA-RCRF10 |
Received CRFs |
Transactional Data |
Visit Date |
Date of the visit when the CRF was collected |
|
TA-RCRF11 |
Received CRFs |
Transactional Data |
CRF Name |
Name of the CRF (e.g. Demog) |
|
TA-RCRF12 |
Received CRFs |
Transactional Data |
CRF Book Name |
Name of the CRF Book used to organize collected pages |
|
TA-RCRF13 |
Received CRFs |
Transactional Data |
Page in CRF Book |
Page number within subject's CRF book on which this CRF is located. |
|
TA-RCRF14 |
Received CRFs |
Transactional Data |
Entry Date |
Date on which the CRF was entered. |
|
TA-RCRF15 |
Received CRFs |
Transactional Data |
Received CRF Status |
Current status of the received CRF |
|
TA-RCRF16 |
Received CRFs |
Transactional Data |
In not verified state? |
Flag indicating whether a received CRF is in not verified state. "Y' means "not verified, else "N". |
|
TA-RCRF17 |
Received CRFs |
Transactional Data |
Awaiting Re-Verification? |
Flag indicating whether a received CRF is awaiting re-verification |
|
TA-RCRF19 |
Received CRFs |
Transactional Data |
In not approved state? |
Flag indicating whether a received CRF is awaiting approval |
|
TA-RCRF20 |
Received CRFs |
Transactional Data |
Awaiting Re-Approval? |
Flag indicating whether a received CRF is awaiting re-approval |
|
TA-RCRF22 |
Received CRFs |
Transactional Data |
Blank? |
Flag indicating whether there is any data for this received DCI. |
|
TA-RCRF23 |
Received CRFs |
Transactional Data |
Soft Locked? |
Flag indicating whether it is acceptable to change data for this received CRF without privileged update |
|
TA-RCRF24 |
Received CRFs |
Transactional Data |
Awaiting first entry completion? |
Flag indicating that a CRF is awaiting first entry completion |
|
TA-RCRF25 |
Received CRFs |
Transactional Data |
Awaiting second entry completion? |
Flag indicating that a CRF is awaiting second entry completion |
|
TA-RCRF26 |
Received CRFs |
Transactional Data |
Completely entered? |
Flag indicating that a CRF is completely entered |
|
TA-RCRF28 |
Received CRFs |
Transactional Data |
Hard Locked? |
If a Received CRF is Hard Locked, data in the CRF is prevented from being modified. This can only be reversed by extraordinary means. |
|
TA-RCRF29 |
Received CRFs |
Transactional Data |
Soft Lock Date |
Date when last Soft locked |
|
TA-RCRF30 |
Received CRFs |
Transactional Data |
Initial Source Verification Date |
Date on which the CRF was initially source-verified |
|
TA-RCRF31 |
Received CRFs |
Transactional Data |
Most Recent Source Verification Date |
Most recent date on which the CRF was source-verified |
|
TA-RCRF32 |
Received CRFs |
Transactional Data |
Initial Approval Date |
Initial date on which the CRF was approved by the Investigator |
|
TA-RCRF33 |
Received CRFs |
Transactional Data |
Most Recent Approval Date |
Most recent date on which the CRF was approved by the Investigator |
|
TA-RCRF34 |
Received CRFs |
Transactional Data |
Hard Lock Date |
Date when last Hard Locked |
|
TA-RCRF35 |
Received CRFs |
Transactional Data |
Data Capture Mode |
Mode in which this CRF was capture. Values = {Paper, EDC} |
|
TA-SITE01 |
Study-site Metrics |
Statistics |
Initial IRB Approval Date |
Earliest IRB Approval date for a Site |
|
TA-SUBJ01 |
Subject Metrics |
Transactional Data |
Subject Status |
Subject Status |
|
TA-SUBJ02 |
Study-Site Metrics |
Statistics |
Initial Informed Consent Date |
Earliest Informed Consent date for a subject |
|
TA-SUBJ03 |
Subject Metrics |
Transactional Data |
Status Comment |
Subject Status Comments |
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.
Table B-3 describes how OCDA 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 |
- |
- |
|
AD02-03 |
- |
- |
|
AD02-04 |
- |
- |
|
AD02-05 |
- |
- |
|
AD02-06 |
- |
- |
|
AD02-07 |
- |
- |
|
AD02-08 |
- |
- |
|
AD02-09 |
- |
- |
|
AD02-10 |
- |
- |
|
AD02-11 |
- |
- |
|
AD02-12 |
- |
- |
|
AD02-13 |
- |
- |
|
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 |
|
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 |
os.clinical_phase |
Not sourced from OC |
|
AD09-11 |
cs.study_status_type_code |
Not sourced from OC |
|
AD09-12 |
cs.title |
Not sourced from OC |
|
AD09-13 |
- |
Not sourced from OC |
|
AD09-14 |
- |
Not sourced from OC |
|
AD09-15 |
- |
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'. |
|
AD10-29 |
- |
Not sourced from OC |
|
AD10-31 |
- |
Not sourced from OC |
|
AD10-32 |
- |
Not sourced from OC |
|
AD10-33 |
- |
Not sourced from OC |
|
AD10-34 |
- |
Not sourced from OC |
|
AD10-35 |
- |
Not sourced from OC |
|
AD10-36 |
- |
Not sourced from OC |
|
AD10-37 |
- |
Not sourced from OC |
|
AD10-38 |
- |
Not sourced from OC |
|
AD10-39 |
- |
Not sourced from OC |
|
AD10-40 |
CLINICAL_STUDIES |
STUDY_STATUS_TYPE_CODE |
|
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 |
|
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 |
|
AD17-01 |
- |
Not sourced from OC |
|
AD17-02 |
- |
Not sourced from OC |
|
AD17-03 |
- |
Not sourced from OC |
|
AD17-04 |
- |
Not sourced from OC |
|
M-DOC01 |
- |
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 |
close date - creation date |
where State = CLOSED; |
|
M-DSC12 |
last ETL date - creation date |
where State = OPEN; |
|
M-DSC15 |
close date - creation date |
where State = CLOSED |
|
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 |
rdci |
count where latest approval has not been undone. |
|
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-REG01 |
- |
Not sourced from OC |
|
M-REG02 |
- |
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 |
- |
Not sourced from OC |
|
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 |
- |
Not sourced from OC |
|
M-SST06 |
pp |
An early terminator is one with an entry in patient_statuses with status of "EARLY TERM" |
|
M-SST06C |
- |
Not sourced from OC |
|
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-SST53 |
- |
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-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 |
|
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-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-SUBJ01 |
- |
Not sourced from OC |
|
TA-SUBJ02 |
- |
Not sourced from OC |
|
TA-SUBJ03 |
- |
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 |
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.
Table B-5 describes how OCDA 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 |
- |
- |
|
AD02-03 |
- |
- |
|
AD02-04 |
- |
- |
|
AD02-05 |
- |
- |
|
AD02-06 |
- |
- |
|
AD02-07 |
- |
- |
|
AD02-08 |
- |
- |
|
AD02-09 |
- |
- |
|
AD02-10 |
- |
- |
|
AD02-11 |
- |
- |
|
AD02-12 |
- |
- |
|
AD02-13 |
- |
- |
|
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 |
S_PROD_INT.TYPE ="Compound" OR S_PROD_INT.TYPE ="Molecule" OR S_PROD_INT.TYPE ="Device" OR S_PROD_INT.TYPE ="Equipment" |
|
AD07-02 |
S_PROD_INT.TYPE |
S_PROD_INT.TYPE ="Compound" OR S_PROD_INT.TYPE ="Molecule" OR S_PROD_INT.TYPE ="Device" OR S_PROD_INT.TYPE ="Equipment" |
|
AD07-03 |
- |
Not sourced from SC |
|
AD07-04 |
S_PROD_INT.DESC_TEXT |
S_PROD_INT.TYPE ="Compound" OR S_PROD_INT.TYPE ="Molecule" OR S_PROD_INT.TYPE ="Device" OR S_PROD_INT.TYPE ="Equipment" |
|
AD07-07 |
S_PROD_INT.PART_NUM |
S_PROD_INT.TYPE ="Compound" OR S_PROD_INT.TYPE ="Molecule" OR S_PROD_INT.TYPE ="Device" OR S_PROD_INT.TYPE ="Equipment" |
|
AD07-08 |
S_PROD_INT.STATUS_CD |
S_PROD_INT.TYPE ="Compound" OR S_PROD_INT.TYPE ="Molecule" OR S_PROD_INT.TYPE ="Device" OR S_PROD_INT.TYPE ="Equipment" |
|
AD07-09 |
S_PROD_INT.ROW_ID |
S_PROD_INT.TYPE ="Compound" OR S_PROD_INT.TYPE ="Molecule" OR S_PROD_INT.TYPE ="Device" OR S_PROD_INT.TYPE ="Equipment" |
|
AD08-01 |
- |
Not sourced from SC |
|
AD08-02 |
S_ADDR_PER.STATE |
- |
|
AD08-03 |
S_ADDR_PER.COUNTRY |
- |
|
AD08-04 |
- |
Not sourced from SC |
|
AD08-05 |
- |
Not sourced from SC |
|
AD08-06 |
S_ORG_EXT.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 |
- |
|
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 |
- |
Not sourced from SC |
|
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 |
- |
|
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 |
- |
|
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 |
- |
|
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 |
- |
|
M-DOC01 |
S_EVT_ACT.ROW_ID |
SUBTYPE_CD='Document' |
|
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-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 |
- |
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-REG01 |
S_CL_PTCL_LS.NUM_PLAN_SITE |
REGION_CD not null AND PAR_PTCL_ID IS NOT NULL |
|
M-REG02 |
S_CL_PTCL_LS.NUM_PLAN_SUBJ |
REGION_CD not null AND PAR_PTCL_ID IS NOT NULL |
|
M-SST01 |
S_PTCL_SITE_LS.NUM_PLAN_SUBJ |
- |
|
M-SST02 |
Count Distinct S_CL_SUBJ_ST_LS.PAR_ROW_ID where S_CL_SUBJ_ST_LS.STATUS_ID = "Enrolled" |
- |
|
M-SST02C |
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 |
Count Distinct S_CL_SUBJ_ST_LS.PAR_ROW_ID where S_CL_SUBJ_ST_LS.STATUS_ID = "Completed" |
- |
|
M-SST05C |
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 |
Count Distinct S_CL_SUBJ_ST_LS.PAR_ROW_ID where S_CL_SUBJ_ST_LS.STATUS_ID = "Early Terminated" |
- |
|
M-SST06C |
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 |
Count Distinct S_CL_SUBJ_ST_LS.PAR_ROW_ID where S_CL_SUBJ_ST_LS.STATUS_ID = "Randomized" |
- |
|
M-SST32C |
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 |
Count Distinct S_CL_SUBJ_ST_LS.PAR_ROW_ID where S_CL_SUBJ_ST_LS.STATUS_ID = "Re-Screened" |
- |
|
M-SST33C |
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 |
Count Distinct S_CL_SUBJ_ST_LS.PAR_ROW_ID where S_CL_SUBJ_ST_LS.STATUS_ID = "Screen Failure" |
- |
|
M-SST34C |
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 |
Count Distinct S_CL_SUBJ_ST_LS.PAR_ROW_ID where S_CL_SUBJ_ST_LS.STATUS_ID = "Screened" |
- |
|
M-SST35C |
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-SST53 |
M-SST02 / M-SST01 |
- |
|
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-STD01 |
S_CL_PTCL_LS.NUM_PLAN_SITE |
- |
|
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 |
- |
|
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-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-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 |
- |
|
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_ST_LS.ROW_ID |
- |
|
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