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Oracle® Health Sciences Pharmacovigilance Operational Analytics User and Administrator Guide
Release 1.0

E23554-01
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B OPVA Presentation Catalog

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

This appendix contains the following topics:

See Also:

Chapter 3, "Working with Reports"

B.1 Dimensions in OPVA Presentation Catalog

Table B-1 describes the Dimensions displayed in the OPVA 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

AD05-03

Case Processing Site

Case Processing Site

Case Processing Site That The User Belongs To.

TA-CVH04

Enterprise

Enterprise ID

CRO Enterprise (Client) Short Name

 

Enterprise

Enterprise Name

Enterprise Name

AD01-01

Period

Year

Per_name_year From W_day_d Table

AD01-02

Period

Quarter

Per_name_qtr From W_day_d Table

AD01-03

Period

Month

Per_name_month From W_day_d Table

AD01-04

Period

Week

Per_name_week From W_day_d Table

AD01-05

Period

Day

Calendar_date From W_day_d Table

AD02-02

Product

Product Group

Therapeutic Alignment Of User Groups By Product Indication (For Example, Oncology Group, Gynecology Group Etc)

AD02-03

Product

Product Family

Product Family - It Is Used To Group Like Products That Share Datasheets And Primary Ingredients

AD02-04

Product

PSUR Group

PSUR Group Name

AD02-01

Product

Product Name

Product Name

AD02-05

Product

Product Formulation

Formulation Of The Product

AD02-06

Product

Product Concentration

Concentration/Strength Of The Product

TA-CRH06

State

State Routed From

Workflow State From Which The Case Was Promoted To The Next Workflow State

TA-CRH07

State

State Routed To

Workflow State From Which The Case Was Promoted From The Previous Workflow State

TA-CWSH04

State

State Name

Workflow State (From Workflow State)

AD03-01

Study

Study ID

Study ID

AD03-02

Study

Project ID

Project ID For Study

TA-CRH10

User

Routing User ID

The User Who Last Worked On The Workflow Step

AD05-02

User

Routing User Name

Routing User Name

AD05-03

User

Case Processing Site

Case Processing Site That The User Belongs To.

TA-CWSH07

User

State Finalization User ID

The User Who Finished The Last Execution Of The Workflow State For The Case Version

AD05-02

User

State Finalization User Name

State Finalization User Name

TA-CRH11

User Group

Routing User Group

User Group Which Worked On The Workflow Step

TA-CWSH08

User Group

State Finalization User Group

The Last User Group To Which The Case Version Was Routed To For The Workflow State

AD06-01

User Group

Routing User Group

User Group Name


B.2 Facts in OPVA Presentation Catalog

Table B-2 describes the Facts displayed in the OPVA 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 Fact Column Description

TA-CVH01

Case

Case ID

Case Identification (Same As Manufacturer Code Number [Mcn])

TA-CVH02

Case

Version ID

Case Version (1,2,3...)

 

Case

Case Internal ID

Internal Case Id Generated

TA-CVH03

Case Version

Version Type

Significant, Non-significant, No Followup - Significant/Non-significant (Is This Follow-up Information Considered Significant, Based On Company Specific Policies? If This Follow-up Information Is Marked As Significant, The Regulatory Report Algorithm Will Re-run And Will Calculate The Due Date Based On The Most Recent Significant Follow-up Date. 1 = Yes, 0 = No)

TA-CVH04

Case Version

Enterprise ID

CRO (Enterprise) Short Name

TA-CVH05

Case Version

Initial/Follow-up

Initial Or Follow-up Entry Of The Case

TA-CVH06

Case Version

Case Deleted Indicator

A Flag To Identify If The Case Has Been "Deleted" Or Not

TA-CVH07

Case Version

Case Creator ID

Case Author (Who Created The Case)

TA-CVH08

Case Version

Case Creator Name

 

TA-CVH09

Case Version

Case Processing Site

Site (Example: Drug Safety Case Processing Location)

TA-CVH10

Case Version

Country Of Incidence

Country Where The Adverse Event Occurred

TA-CVH10

Case Version

Case Type

Case Report Type (For Ex., Spontaneous/Clinical/Literature, Etc.)

TA-CVH11

Case Version

Compliance Classification

7-day Case, 15-day Case, Non-Expedited Case

TA-CVH12

Case Version

S/R/U Classification

SAE Case, SAR Case, SUSAR Case

TA-CVH13

Case Version

F/LT Classification

Fatal/Life-Threatening Case

TA-CVH14

Case Version

Pregnancy Classification

Pregnancy Case

TA-CVH15

Case Version

Source Classification

Authority Case, Consumer Case, Literature Case

TA-CVH16

Case Version

Confirmation Classification

Medically Confirmed Case

TA-CVH17

Case Version

Case Classification Group7

Case Classification Group7

TA-CVH18

Case Version

Case Classification Group8

Case Classification Group8

TA-CVH19

Case Version

Case Classification Group9

Case Classification Group9

TA-CVH20

Case Version

Case Classification Group10

Case Classification Group10

TA-CVH21

Case Version

Product Type

Drug, Device, And Vaccine

TA-CVH22

Case Version

Study ID

Study ID

TA-CVH23

Case Version

Center ID

Center ID For The Study In The Case Version

TA-CVH24

Case Version

Case Seriousness

Case Serious or Non-Serious (Y/N)

TA-CVH25

Case Version

Case Listedness

Unlisted/Unexpected/Listed/Expected

TA-CVH26

Case Version

Case Causality

Adverse Event Caused By The Product (Related/Not Related)

TA-CVH27

Case Version

Case Outcome

Case Level Outcome Using The ICH Guidelines. Example: 'Recovered;

TA-CVH28

Case Version

Gender

Gender Of The Patient

TA-CVH29

Case Version

Pregnant

Patient Pregnant (Yes/No)

TA-CVH30

Case Version

Age Group

Patient Age Group

TA-CVH31

Case Version

Ethnicity

Ethnicity Of The Patient

TA-CVH32

Case Version

Lactation

Patient Breastfeeding

TA-CVH33

Case Version

Primary Reporter Type

Type Of The First/Primary Reporter (Example: Physician, Consumer, Etc.)

TA-CVH34

Case Version

Primary Suspect Product

Primary Suspect Product For A Case

TA-CVH35

Case Version

HCP

Health Care Professional (Example: Physician, Nurse, Pharmacist) Flag. Primary Reporter Of The Case Is HCP Or Not.

TA-CVH36

Case Version

SUSAR

Suspected Unexpected Serious Adverse Reaction Flag (0 / 1)

TA-CVH37

Case Version

Case Owner ID

User Who Is Responsible For The Case Throughout Its Lifetime

 

Case Version

Case Owner Name

 

TA-CVH38

Case Version

Initial Receipt Date

Date On Which Initial Case Information Was Received

TA-CVH39

Case Version

Version Receipt Date

Date On Which Initial/follow-up Information Was Received

TA-CVH40

Case Version

Safety Receipt Date

Case Version Receipt Date At Central Safety

TA-CVH41

Case Version

Clock Start Date

Case Version Aware Date

TA-CVH42

Case Version

Version Creation Timestamp

The Timestamp When The Case Version Was Created (Case Book-in Timestamp For Initial Case Version Or Routing Timestamp When The Case Was Unlocked/Unarchived For Other Case Versions)

TA-CVH43

Case Version

Lock Timestamp

Case Is Ready For Submission. First Lock Date Of The Case Version.

TA-CVH44

Case Version

Case Deletion Date

Date Of Case Deletion

M-CVH01

Case Version

Lock Target Days

Number Of Target Days For Processing A Case Version Which Is Number Of Days From Clock Start Date To Lock Timestamp

M-CVH02

Case Version

Lock Due Date

Clock Start Date + Lock Target Days

M-CVH03

Case Version

Lock Due Due Date Soon

Customizable By The Customer, By Default - 2 Days Lock Due Date - (2)

M-CVH04

Case Version

Duration Version-Receipt-To-Safety-Receipt

(How Long Does It Take Before A Case Version Reaches The Safety Group?) The Difference Between The Case Version Receipt Date And The Case Version Safety Receipt Date.

M-CVH05

Case Version

Duration Clock-Start-To-Lock

Interval Between Case Version Clock Start Date And Case Version Lock Datetime

M-CVH06

Case Version

Duration Version-Creation-To-Lock

Interval Between Case Version Create DateTime And Case Version Lock Datetime

M-CVH07

Case Version

Avg Duration Clock-Start-To-Lock

Average Interval between Case Version Clock Start Date and Case Version Lock DateTime

M-CVH08

Case Version

Avg Duration Version-Creation-To-Lock

Average Interval Between Case Version Create DateTime And Case Version Lock DateTime

M-CVH09

Case Version

Min Duration Clock-Start-To-Lock

Minimum Interval Between Case Version Clock Start Date And Case Version Lock DateTime

M-CVH10

Case Version

Min Duration Version-Creation-To-Lock

Minimum Interval Between Case Version Create DateTime And Case Version Lock DateTime

M-CVH11

Case Version

Max Duration Clock-Start-To-Lock

Maximum Interval Between Case Version Clock Start Date And Case Version Lock DateTime

M-CVH12

Case Version

Max Duration Version-Creation-To-Lock

Maximum Interval Between Case Version Create DateTime And Case Version Lock DateTime

M-CVH13

Case Version

#Versions Locked Once

Number Of Case Versions Received (Including All Versions)

M-CVH14

Case Version

#Sig Versions Locked Once

Number Of Case Versions Received (Including Significant Versions Only)

M-CVH15

Case Version

#Versions Locked On-Time

Number Of Case Versions Processed Within Target Days

M-CVH16

Case Version

%Versions Locked On-Time

Percentage Of Case Versions Processed On Time

M-CVH17

Case Version

#Versions Locked Late

Number Of Case Versions Processed Over Target Days

M-CVH18

Case Version

%Versions Locked Late

Percentage Of Case Versions Not Processed Within Target Days

TA-CRH03

Case Routing

Enterprise ID

CRO Enterprise (Client) ID

TA-CRH04

Case Routing

Routing Justification

Case Routing Justification

TA-CRH05

Case Routing

Routing ID

Workflow Sequence Number

TA-CRH08

Case Routing

Routing Timestamp From State

The Timestamp On Which Case Was Routed From Workflow State

TA-CRH09

Case Routing

Routing Timestamp To State

The Timestamp On Which Case Was Routed To Workflow State

TA-CRH12

Case Routing

Follow-up ID

Follow-up Number Of The Case To Which This Routing Record Belongs.

TA-CRH13

Case Routing

Comments

Routing Comments

 

Case Routing

Pseudo State

 

TA-CRH03

Case Workflow State

Enterprise ID

CRO Enterprise (Client) Short Name

TA-CRH05

Case Workflow State

State Start Timestamp

The First Timestamp When The Workflow State Was Started

TA-CRH06

Case Workflow State

State End Timestamp

The Last Timestamp When The Workflow State Was Completed

M-CWSH01

Case Workflow State

#Time State Repeated

The Number Of Times A Workflow State Is Repeated (Within A Case Version)

M-CWSH02

Case Workflow State

#Users Who Worked On State

Number Of Distinct Users Who Worked On A Workflow State For A Case Version

M-CWSH03

Case Workflow State

Duration State-Start-To-End

Number Of Days Taken From The First Time The Workflow State Was Started To The Last Time The Workflow State Was Completed (Within A Case Version)

M-CWSH04

Case Workflow State

Duration Within State

Total Time The Case Spent In The Workflow State (Within A Case Version)

M-CWSH05

Case Workflow State

# Completed State

Total Number Of Workflow States Completed

M-CWSH06

Case Workflow State

# Repeated State

Total Count Of All The Workflow States That Were Repeated

M-CWSH07

Case Workflow State

% Repeated State

Total Percentage Of All The Workflow States That Were Repeated

M-CWSH08

Case Workflow State

Duration Version-Creation-To-State-End

Time Taken To Accomplish A Workflow State After A Case Version Was Created (Including Any Repetition)

M-CWSH09

Case Workflow State

Average Duration State-Start-To-End

Average Number Of Days Taken From The First Time The Workflow State Was Started To The Last Time The Workflow State Was Completed (Within A Case Version)

M-CWSH10

Case Workflow State

Average Duration Within State

Average Time The Case Spent In The Workflow State (Within A Case Version)

M-CWSH11

Case Workflow State

Average Duration Version-Creation-To-State-End

Average Time Taken To Accomplish A Workflow State After A Case Version Was Created (Including Any Repetition)

M-CWSH12

Case Workflow State

Minimum Duration State-Start-To-End

Minimum Number Of Days Taken From The First Time The Workflow State Was Started To The Last Time The Workflow State Was Completed (Within A Case Version)

M-CWSH13

Case Workflow State

Minimum Duration Within State

Minimum Time The Case Spent In The Workflow State (Within A Case Version)

M-CWSH14

Case Workflow State

Minimum Duration Version-Creation-To-State-End

Minimum Time Taken To Accomplish A Workflow State After A Case Version Was Created (Including Any Repetition)

M-CWSH15

Case Workflow State

Maximum Duration State-Start-To-End

Maximum Number Of Days Taken From The First Time The Workflow State Was Started To The Last Time The Workflow State Was Completed (Within A Case Version)

M-CWSH16

Case Workflow State

Maximum Duration Within State

Maximum Time The Case Spent In The Workflow State (Within A Case Version)

M-CWSH17

Case Workflow State

Maximum Duration Version-Creation-To-State-End

Maximum Time Taken To Accomplish A Workflow State After A Case Version Was Created (Including Any Repetition)

TA-PC01

Pending Cases

Case ID

Case Identification (Same As Manufacturer Code Number - MCN)

 

Pending Cases

Case Internal ID

 

TA-PC02

Pending Cases

Follow-up ID

Latest Case Follow-up # (0,1,2,3...)

TA-PC03

Pending Cases

Follow-up Type

Significant, Non-Significant - Significant/Non-Significant (Is This Follow-up Information Considered Significant, Based On Company Specific Policies? If This Follow-up Information Is Marked As Significant, The Regulatory Report Algorithm Will Re-Run And Will Calculate The Due Date Based On The Most Recent Significant Follow-up Date)

TA-PC04

Pending Cases

Enterprise ID

CRO Enterprise (Client) Short Name

TA-PC06

Pending Cases

Case Creator ID

Case Author (Who Created The Case)

TA-PC07

Pending Cases

Case Processing Site

Site (For Example, Drug Safety Case Processing Location)

TA-PC08

Pending Cases

Country of Incidence

Country Where The Adverse Event Occurred

TA-PC09

Pending Cases

Case Type

Case Report Type (For Example, Spontaneous/Clinical/Literature, Etc.)

TA-PC10

Pending Cases

Compliance Classification

7-day Case, 15-day Case, Non-Expedited Case

TA-PC11

Pending Cases

S/R/U Classification

SAE Case, SAR Case, SUSAR Case

TA-PC12

Pending Cases

F/LT Classification

Fatal / Life-Threatening Case

TA-PC13

Pending Cases

Pregnancy Classification

Pregnancy Case

TA-PC14

Pending Cases

Source Classification

Authority Case, Consumer Case, Literature Case

TA-PC15

Pending Cases

Confirmation Classification

Medically Confirmed Case

TA-PC16

Pending Cases

Case Classification Group 7

Case Classification Group 7

TA-PC17

Pending Cases

Case Classification Group 8

Case Classification Group 8

TA-PC18

Pending Cases

Case Classification Group 9

Case Classification Group 9

TA-PC19

Pending Cases

Case Classification Group 10

Case Classification Group 10

TA-PC20

Pending Cases

Product Type

Drug, Device and Vaccine

TA-PC21

Pending Cases

Study Type

Study ID

TA-PC22

Pending Cases

Center ID

Center ID for the Study in the case version

TA-PC23

Pending Cases

Case Seriousness

Case Serious Or Non-serious (Y/N)

TA-PC24

Pending Cases

Case Listedness

Unlisted/Unexpected/Listed/Expected

TA-PC25

Pending Cases

Case Causality

Adverse Event Caused By The Product (Related/Not Related)

TA-PC26

Pending Cases

Case Outcome

Case Level Outcome Using The ICH Guidelines, Such As 'Recovered'

TA-PC27

Pending Cases

Gender

Gender Of The Patient

TA-PC28

Pending Cases

Pregnant

Patient Pregnant (Yes/No)

TA-PC29

Pending Cases

Age Group

Patient Age Group

TA-PC30

Pending Cases

Ethnicity

Ethnicity Of The Patient

TA-PC31

Pending Cases

Lactation

Patient Breastfeeding

TA-PC32

Pending Cases

Primary Reporter Type

Type Of Reporter (Example: Physician, Consumer, Etc.)

TA-PC33

Pending Cases

Primary Suspect Product

Primary Suspect Product For A Case

TA-PC34

Pending Cases

HCP

Health Care Professional (Such As Physician, Nurse, Pharmacist) Flag. Primary Reporter Of The Case Is Hcp Or Not

TA-PC35

Pending Cases

SUSAR

Suspected Unexpected Serious Adverse Reaction Flag (0 / 1)

TA-PC36

Pending Cases

Initial Receipt Date

Date On Which Initial Case Information Was Received

TA-PC37

Pending Cases

Latest Followup Receipt Date

Date On Which Latest Follow-up Information Was Received. If There Is No Followup Then Followup Receipt Date Will Be Null

TA-PC40

Pending Cases

Clock Start Date

Case Version Aware Date

TA-PC50

Pending Cases

Case Deletion Date

Deletion Date Of The Case

TA-PC41

Pending Cases

Case Owner

User Who Is Responsible For The Case Throughout Its Lifetime

TA-PC42

Pending Cases

Assigned User

User Assigned To The Current Work

TA-PC43

Pending Cases

User With Case Open

Case Worklist User. User Who Has The Case Open (It May Be Null If Case Is Not Open)

TA-PC44

Pending Cases

Routing Justification

Case Routing Justification For The Latest Routing

TA-PC45

Pending Cases

Routing ID

Workflow Sequence Number

TA-PC46

Pending Cases

Routing Timestamp

The Timestamp On Which Case Was Routed To Current Workflow State

TA-PC47

Pending Cases

Start Name

Workflow State To Which Case Was Promoted From Previous Workflow State

TA-PC48

Pending Cases

Routing User

The User To Whom The Case Has Been Routed In The Current Workflow State

TA-PC49

Pending Cases

Routing User Group

User Group To Which A Case Is Routed.

M-PC01

Pending Cases

Earliest Exp Report Due Date

Earliest Due Date By External(Regulatory/sla) For Expedited Report For This Case Version. This Measure Will Have Null Value If There Are No Reports Due For This Case Version.

M-PC02

Pending Cases

Earliest Exp Report Due Soon Date

Earliest Due Date By Internal Process For Expedited Report For This Case Version. This Measure Will Have Null Value If There Are No Reports Due For This Case Version.

M-PC03

Pending Cases

Earliest Exp Report On-Time Indicator

Earliest Expedited Report Submission On-time Indicator. The Values Here Are Red, Yellow And Green.

M-PC04

Pending Cases

Lock Target Days

Target Days For Processing A Case Version Which Is Number Of Days From Clock Start Date To Lock Datetime.

M-PC05

Pending Cases

Lock Due Date

Due Date For Locking A Case (Case Processing Completion)

M-PC06

Pending Cases

Lock Due Soon Date

Internal Due Date For Locking A Case (Case Processing Completion)

M-PC07

Pending Cases

Lock On-Time Indicator

Case Version Lock On-time Indicator. The Values Here Are Red, Yellow And Green.

M-PC08

Pending Cases

Start Due Date - I

Due Date For Completion Of A Workflow State By Static Workflow Method

M-PC09

Pending Cases

Start Due Soon Date - I

Due Soon Date For Completion Of A Workflow State By Static Workflow Method

M-PC10

Pending Cases

Start On-Time Indicator - I

Workflow State On-Time Indicator by Static Workflow Method. The values here are Red, Yellow and Green

M-PC11

Pending Cases

Start Due Date - II

Due Date For Completion Of A Workflow State By Dynamic Workflow Method

M-PC12

Pending Cases

Start Due Soon Date - II

Due Soon Date For Completion Of A Workflow State By Dynamic Workflow Method

M-PC13

Pending Cases

Start On-Time Indicator - II

Workflow State On-time Indicator By Dynamic Workflow Method. The Values Here Are Red, Yellow And Green

M-PC14

Pending Cases

Case-Open-By-User Indicator

Case Currently Worked Upon By Any User

M-PC15

Pending Cases

# Unlocked Cases w Expedited Report On-Time

Count Of Open Cases With Expedited Report On-time (Where Earliest Exp Report On-time Indicator Is Green)

M-PC16

Pending Cases

# Unlocked Cases w Expedited Report Due Soon

Count Of Open Cases With Expedited Report Due Soon (Where Earliest Exp Report On-time Indicator Is Yellow)

M-PC17

Pending Cases

# Unlocked Cases w Expedited Report Overdue

Count Of Open Cases With Expedited Report Overdue (Where Earliest Exp Report On-time Indicator Is Red)

M-PC18

Pending Cases

# Unlocked Cases On-Time

Count Of Open Cases Where Case Processing Is On-time (Lock On-time Indicator Is Green)

M-PC19

Pending Cases

# Unlocked Cases Due Soon

Count Of Open Cases Where Case Processing Is Due Soon (Lock On-time Indicator Is Yellow)

M-PC20

Pending Cases

# Unlocked Cases Overdue

Count Of Open Cases That Have Not Been Completed Past Due Date (Lock On-time Indicator Is Red)

M-PC21

Pending Cases

# Unlocked Cases w State On-Time - I

Count Of Cases With Workflow State Completion On-time By Static Workflow Method

M-PC22

Pending Cases

# Unlocked Cases w State Due Soon - I

Count Of Cases With Workflow State Completion Due Soon By Static Workflow Method

M-PC23

Pending Cases

# Unlocked Cases w State Overdue - I

Count Of Cases With Workflow State Not Been Completed Past Due Date By Static Workflow Method

M-PC24

Pending Cases

# Unlocked Cases w State On-Time - II

Count Of Cases With Workflow State Completion On-time By Dynamic Workflow Method

M-PC25

Pending Cases

# Unlocked Cases w State Due Soon - II

Count Of Cases With Workflow State Completion Due Soon By Dynamic Workflow Method

M-PC26

Pending Cases

# Unlocked Cases w State Overdue - II

Count of cases with Workflow State not been completed past due date by Dynamic Workflow method

M-PC27

Pending Cases

# Unlocked Cases

Total Number of Pending Cases


B.3 Oracle Argus Safety Sources for OPVA Presentation Catalog

Table B-3 describes how OPVA populates each column from an Oracle Argus Safety 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.

Table B-3 Presentation Catalog - Oracle Argus Safety Sources

ID Source Table/Column Comments/Details

TA-CVH01

case_master.case_num

 

TA-CVH02

 

A new case version is created whenever a case is unlocked or reopened. Version number starting with 1 and incremented by 1 for every new version.

 

case_master.case_id

 

TA-CVH03

 

No Followup: If there is no followup between two Version Lock DateTimeSignificant: If there is atleast 1 significant followup between two Version Lock DateTimeNon-Significant: If there is followup but no significant followup between two Version Lock DateTime

TA-CVH04

cfg_enterprise.enterprise_abbrv

 

TA-CVH05

 

If Version = 1 then Initial Else Follow-up

TA-CVH06

case_master.deleted

 

TA-CVH07

case_master.user_id

 
 

cfg_users.user_fullname

 

TA-CVH08

case_master.site_id

 

TA-CVH09

case_master.country_id

 

TA-CVH10

case_master.Report_type

 

TA-CVH11

 

..where lm_case_classification.description has values in (7-day Case, 15-day Case, Non-Expedited Case)

TA-CVH12

 

..where lm_case_classification.description has values in (SAE Case, SAR Case, SUSAR Case)

TA-CVH13

 

..where lm_case_classification.description has values in (Fatal / Life-Threatening Case)

TA-CVH14

 

..where lm_case_classification.description has values in (Pregnancy Case)

TA-CVH15

 

..where lm_case_classification.description has values in (Authority Case, Consumer Case, Literature Case)

TA-CVH16

 

..where lm_case_classification.description has values in (Medically Confirmed Case)

TA-CVH17

 

..where lm_case_classification.description has values in (Case Classification 7)

TA-CVH18

 

..where lm_case_classification.description has values in (Case Classification 8)

TA-CVH19

 

..where lm_case_classification.description has values in (Case Classification 9)

TA-CVH20

 

..where lm_case_classification.description has values in (Case Classification 10)

TA-CVH21

case_product.views_available

 

TA-CVH22

case_study.study_num

 

TA-CVH23

lm_centers.center_no

 

TA-CVH24

case_assess.seriousness

 

TA-CVH25

case_assess.listedness

 

TA-CVH26

case_assess.agent_suspect

 

TA-CVH27

case_assess.outcome

 

TA-CVH28

case_pat_info.gender_id

 

TA-CVH29

case_pat_info.pat_stat_preg

 

TA-CVH30

case_pat_info.age_group_id

 

TA-CVH31

case_pat_info.ethnicity_id

 

TA-CVH32

case_pregnancy.breastfeeding

 

TA-CVH33

case_reporters.reporter_type

 

TA-CVH34

case_product.product_name

 

TA-CVH35

case_reporters.hcp_flag

 

TA-CVH36

case_master.susar

 

TA-CVH37

case_master.worklist_owner_id

 
 

cfg_users.user_fullname

 

TA-CVH38

case_master.init_rept_date

 

TA-CVH39

case_followup.receipt_date (Case_Master.init_rept_date for Initial case version)

 

TA-CVH40

case_followup.safety_date

 

TA-CVH41

 

Max(case_master.init_rept_date/(case_followup.receipt_date where significant = 1))

TA-CVH42

 

For initial case version, case_master.create_time and for other case versions it is case_routing.route_date where lower(case_routing.comment_text) like 'case unlocked%' or case_routing.to_state_id = 2

TA-CVH43

 

case_routing.route_date where case_routing.comment_text like 'case locked%' or case_routing.to_state_id = 2

TA-CVH44

case_master.deleted

 

M-CVH01

 

It shall be customizable by the customer, they shall be able to write the logic to populate this column. By default - If Case Serious then 10 Days else 30 Days

M-CVH02

 

Clock Start Date + Lock Target Days

M-CVH03

 

Customizable By The Customer, By Default - 2 Days Lock Due Date - (2)

M-CVH04

 

days between (Safety Receipt Date, Version Receipt Date)

M-CVH05

 

days between (Clock Start Date, Lock Timestamp)

M-CVH06

 

days between (Version Creation Timestamp, Lock Timestamp)

M-CVH07

 

Sum(Duration Clock-Start-To-Lock)/# Versions Locked Once

M-CVH08

 

Sum(Duration Version-Creation-To-Lock)/# Versions Locked Once

M-CVH09

 

Minimum(Duration Clock-Start-To-Lock)

M-CVH10

 

Minimum(Duration Version-Creation-To-Lock)

M-CVH11

 

Maximum(Duration Clock-Start-To-Lock)

M-CVH12

 

Maximum(Duration Version-Creation-To-Lock)

M-CVH13

 

Count (Number of records from Case Version History)

M-CVH14

 

Count (Number of records from Case Version History) where Version Type = Significant

M-CVH15

 

Lock Timestamp - Clock Start Date <= Lock Target Days

M-CVH16

 

(# Versions Locked On-Time/# Versions Locked Once) * 100

M-CVH17

 

Lock Timestamp - Clock Start Date > Lock Target Days

M-CVH18

 

(# Versions Locked Late/# Versions Locked Once) * 100

TA-CRH03

cfg_enterprise.enterprise_abbrv

 

TA-CRH04

case_routing.justification_id

 

TA-CRH05

case_routing.seq_num

 

TA-CRH08

case_routing.route_date

 

TA-CRH09

case_routing.route_date

 

TA-CRH12

 

Followup # as appear on Argus Case Form against each followup starting with 1 and incremented by 1 for every new folllowup. (case_routing.followup_num joins with case_followup.seq_num)

TA-CRH13

case_routing.comment_text

Routing Comments

   

Derived Column: 2. There are three Pseudo states – a. Locked – Whenever there is a lock, 'Routing From State' shall be TO_STATE_ID of case and 'Routing To State' shall be 'Locked'.b. F/U Data Entry - Whenever there is Unlock, 'Routing From State' shall be 'F/U Data Entry' and 'Routing To State' shall be TO_STATE_ID of the routing record immediately after the unlock.c. Unarchived – Whenever case is unarchived, 'Routing From State' shall be FROM_STATE_ID of case and 'Routing To State' shall be 'Unarchived'.

TA-CRH03

cfg_enterprise.enterprise_abbrv

 

TA-CRH05

   

TA-CRH06

 

The Last Timestamp When The Workflow State Was Completed

M-CWSH01

 

Count(*) -1Group by ("Case Routing History"."Case ID", "Version", "State Routed From")If case goes through workflow states A -> B -> A -> B -> A -> B -> C, then result for B is 2

M-CWSH02

 

count(Distinct "Case Routing History".Routing User) Group by ("Case Routing History"."Case ID", "Version", "State Routed From")

M-CWSH03

 

If case goes through workflow states A -> B -> A -> B -> A -> B -> C, then result for B is duration from beginning of first B through end of last B, including time spent in second and third A

M-CWSH04

 

Sum ("Case Routing History".Routing Timestamp To State - "Case Routing History".Routing Timestamp From State) Group by ("Case Routing History"."Case ID", "Version", "State Routed From")If case goes through workflow states A -> B -> A -> B -> A -> B -> C, then result for B is duration of first B plus duration of second B plus duration of third B (does NOT include any time spent in A)

M-CWSH05

 

count (State Name) If case goes through workflow states A -> B -> A -> B -> A -> B -> C, then result is 3

M-CWSH06

 

count (State Name) where "# Times State Repeated" > 0If case goes through workflow states A -> B -> A -> B -> A -> B -> C, then result is 2

M-CWSH07

 

(# Repeated States / # Completed States ) * 100If case goes through workflow states A -> B -> A -> B -> A -> B -> C, then result is 66.6%

M-CWSH08

 

State End Timestamp - Version Creation Timestamp

M-CWSH09

 

total(Duration State-Start-To-End) for all case versions / # Versions Locked Once

M-CWSH10

 

total(Duration Within State) for all case versions / # Versions Locked Once

M-CWSH11

 

total(Duration Version-Creation-To-State-End) for all case versions / # Versions Locked Once

M-CWSH12

 

minimum(Duration State-Start-To-End)

M-CWSH13

 

minimum(Duration Within State)

M-CWSH14

 

minimum(Duration Version-Creation-To-State-End)

M-CWSH15

 

maximum(Duration State-Start-To-End)

M-CWSH16

 

maximum(Duration Within State)

M-CWSH17

 

maximum(Duration Version-Creation-To-State-End)

AD06-01

cfg_groups.group_name

 

TA-PC01

case_master.case_num

 
 

case_master.case_id

 

TA-PC02

case_routing.followup_num

Followup # as appear on Argus Case Form for the latest followup. It shall be 0 if the latest case version is Initial

TA-PC03

case_followup.significant

If Case_followup.Significant = 1 then 'Significant' else 'Non-Significant'. If the latest case version is Initial then 'Significant'

TA-PC04

cfg_enterprise.enterprise_abbrv

 

TA-PC06

case_master.user_id

 

TA-PC07

case_master.site_id

 

TA-PC08

case_master.country_id

 

TA-PC09

case_master.report_type

 

TA-PC10

lm_case_classification.description

..where lm_case_classification.description has values in (7-day Case, 15-day Case, Non-Expedited Case)

TA-PC11

lm_case_classification.description

..where lm_case_classification.description has values in (SAE Case, SAR Case, SUSAR Case)

TA-PC12

lm_case_classification.description

..where lm_case_classification.description has values in (Fatal / Life-Threatening Case)

TA-PC13

lm_case_classification.description

..where lm_case_classification.description has values in (Pregnancy Case)

TA-PC14

lm_case_classification.description

..where lm_case_classification.description has values in (Authority Case, Consumer Case, Literature Case)

TA-PC15

lm_case_classification.description

..where lm_case_classification.description has values in (Medically Confirmed Case)

TA-PC16

lm_case_classification.description

..where lm_case_classification.description has values in (Case Classification 7)

TA-PC17

lm_case_classification.description

..where lm_case_classification.description has values in (Case Classification 8)

TA-PC18

lm_case_classification.description

..where lm_case_classification.description has values in (Case Classification 9)

TA-PC19

lm_case_classification.description

..where lm_case_classification.description has values in (Case Classification 10)

TA-PC20

case_product.views_available

 

TA-PC21

case_study.study_num

 

TA-PC22

lm_centers.center_no

where case_study.center_id = lm_centers.center_id

TA-PC23

case_assess.seriousness

 

TA-PC24

case_assess.listedness

 

TA-PC25

case_assess.agent_suspect

 

TA-PC26

case_assess.outcome

 

TA-PC27

case_pat_info.gender_id

 

TA-PC28

case_pat_info.pat_stat_preg

 

TA-PC29

case_pat_info.age_group_id

 

TA-PC30

case_pat_info.ethnicity_id

 

TA-PC31

case_pregnancy.breastfeeding

 

TA-PC32

case_reporters.reporter_type

where primary_contact = 1

TA-PC33

case_product.product_name

where case_product.first_sus_prod = 1

TA-PC34

case_reporters.hcp_flag where

primary_contact = 1

TA-PC35

case_master.susar

 

TA-PC36

case_master.init_rept_date

 

TA-PC37

case_followup.receipt_date

 

TA-PC40

max(case_master.init_rept_date/(case_followup.receipt_date where significant = 1))

 

TA-PC50

case_master.deleted

 

TA-PC41

case_master.worklist_owner_id

 

TA-PC42

case_master.owner_id

 

TA-PC43

web_cases_open.user_id

 

TA-PC44

case_routing.justification_id

 

TA-PC45

case_routing.seq_num

 

TA-PC46

case_routing.route_date

 

TA-PC47

cfg_workflow_states.state_name

where case_routing.to_state_id = cfg_workflow_states.state_id

TA-PC48

case_routing.user_id

 

TA-PC49

cfg_workflow_rules.group_id

where cfg_workflow_rules.seq_num = case_routing.workflow_seq_num

M-PC01

case_master.due_soon

 

M-PC02

case_master.due_soon - (2)

It shall be customizable by the customer, they shall be able to write the logic to populate this column. By default - 2 Days

M-PC03

 

when due_soon - due_soon_val > sysdate then 1; when sysdate between (due_soon - due_soon_val) and due_soon then 2; when sysdate > cvd.due_soon then 3

M-PC04

 

It is customizable by the customer. They can write the logic to populate this column. By default, if Case Serious then 10 Days, else 30 Days

M-PC05

 

clock_start_date + lock_target_days

M-PC06

 

It shall be customizable by the customer, they shall be able to write the logic to populate this column. By default - 2 Days Pending Cases Fact. Lock Due Date - (2)

M-PC07

 

when (clock_start_date + lock_target_days - due_soon_val) > sysdate then 1when sysdate between (clock_start_date + lock_target_days - due_soon_val) and (clock_start_date + lock_target_days) then 2when sysdate > (clock_start_date + lock_target_days) then 3

M-PC08

 

case_routing.route_date + cfg_workflow_rules.max_time

M-PC09

 

nvl(to_number(to_char(routing_timestamp + max_time, 'RRRRMMDD')), -1)

M-PC10

 

when routing_timestamp + normal_time > sysdate then 1when sysdate between (routing_timestamp + normal_time) and (routing_timestamp + max_time) then 2when sysdate > (routing_timestamp + max_time) then 3

M-PC11

 

routing_timestamp + ((case due_soon - trunc(due_soon)when 0 then (due_soon + (86399 / 86400)) else cvd.due_soon - case

when followup_max_time_stamp > nvl(create_time, followup_max_time_stamp - 1) then followup_max_time_stampelse reate_time) * (state_unit/total_state_units)) case_dyn_due_date_2, nvl(to_number(to_char(cvd.routing_timestamp + ((case cvd.due_soon - trunc(cvd.due_soon)when 0 then (cvd.due_soon + (86399 / 86400)) else due_soon"

M-PC12

 

routing_timestamp - due_soon_val +((case due_soon - trunc(due_soon) when 0 then (due_soon + (86399 / 86400))else due_soon - case when followup_max_time_stamp > nvl(create_time, followup_max_time_stamp - 1) thenfollowup_max_time_stamp else create_time) * (state_unit/total_state_units)

M-PC13

 

when state due date - II > current_date then 1

when current_date between state due soon date - II and state due date - II then 2when current_date > state due soon date - II then 3

M-PC14

web_cases_open.case_id

 

M-PC15

 

sum(if due soon >= sysdate then 1 else 0)

M-PC16

 

sum(if due soon - due soon val >= sysdate then 1 else 0 )

M-PC17

 

sum(if due soon < sysdate then 1 else 0)

M-PC18

 

sum(if clock start date + lock target days - due soon val) >= sysdate then 1 else 0)

M-PC19

 

sum(if sysdate between (clock start date + lock target days - due soon val) and (clock start date + lock target days) then 1 else 0)

M-PC20

 

sum(if (clock start date + lock target days) < sysdate then 1 else 0)

M-PC21

 

sum(if (routing timestamp + normal time) >= sysdate then 1 else 0)

M-PC22

 

sum(if sysdate between (routing timestamp + normal time) and (routing timestamp + max time) then 1 else 0)

M-PC23

 

sum(if (routing timestamp + max time) < sysdate then 1 else 0)

M-PC24

 

sum(dynamic case on time)

M-PC25

 

sum(dynamic case due soon)

M-PC26

 

sum(dynamic case overdue)

M-PC27

 

count(case when not case_internal_id is null then 1 end)