| Oracle® Health Sciences Pharmacovigilance Operational Analytics User and Administrator Guide Release 1.0 E23554-01 |
|
|
PDF · Mobi · ePub |
| Oracle® Health Sciences Pharmacovigilance Operational Analytics User and Administrator Guide Release 1.0 E23554-01 |
|
|
PDF · Mobi · ePub |
This section describes predefined dashboards and reports delivered with Oracle Pharmacovigilance Operational Analytics (OPVA):
See Also:
OPVA is delivered with three dashboards. These dashboards can be accessed by users with a specific job responsibility and security privileges. Each dashboard has tabbed pages that display reports.
OPVA includes the following dashboards:
Log in to OPVA, and select the dashboard you want to view. For more information, refer to Accessing Oracle Health Sciences Pharmacovigilance Operational Analytics.
This section describes the Case Processing History dashboard in OPVA.
This dashboard of retrospective metrics (or trailing KPIs) can be accessed by an Executive Manager or Team Leader. It provides reports on completed case versions, that is case versions that are already locked.
This dashboard includes the following prompt, which is common to all its pages:
Enterprise ID: Lists the unique identifier for the enterprise.
This dashboard includes the following tabbed pages:
This page displays reports on the volume of completed case versions. This page includes the following prompts, which are common to all its reports:
Deleted Case: Lists whether the case is a deleted case.
Case Processing Site: Lists the name of the case processing site.
Country of Incidence: Lists the country of incidence.
Case Seriousness: Lists the seriousness level for the case.
Gender: Lists the gender of the patient reported in the case.
Age Group: Lists the age group of the patient reported in the case.
Case Type: Lists the type of case.
Study ID: Lists the unique identifier for the study.
Product Group: Lists the product group in the case.
Product Family: Lists product family in the case.
Product Name: Lists the product name in the case.
Version Receipt Month Between: Lists the month range for the version receipt.
This page includes the following reports:
This page displays reports on the lock compliance of completed case versions, that is whether cases have been locked on time or not. This page includes the following prompts, which are common to all its reports:
Deleted Case: Lists whether the case is a deleted case.
Case Processing Site: Lists the name of the case processing site.
Country of Incidence: Lists the country of incidence.
Case Seriousness: Lists the seriousness level for the case.
Gender: Lists the gender of the patient reported in the case.
Age Group: Lists the age group of the patient reported in the case.
Case Type: Lists the type of case.
Study ID: Lists the unique identifier for the study.
Product Group: Lists the product group in the case.
Product Family: Lists product family in the case.
Product Name: Lists the product name in the case.
Version Receipt Month Between: Lists the month range for the version receipt.
This page includes the following reports:
This page displays reports on the workflow state repetition of completed case versions, that is whether workflow states in the same case version have been repeated or not. This page includes the following prompts, which are common to all its reports:
Case Processing Site: Lists the name of the case processing site.
Study ID: Lists the unique identifier for the study.
Product Group: Lists the product group in the case.
Product Family: Lists product family in the case.
Product Name: Lists the product name in the case.
State Name: Lists the name of the state in the case.
State Finalization User ID: Lists the state finalization User ID in the case.
State Finalization User Group: Lists the state fina in the case.
State Start Date Between: Lists the start date for the state.
State End Date Between: Lists the end date for the state.
This page includes the following reports:
This section describes the Case Processing Management dashboard in OPVA.
This dashboard of current metrics (or effective KPIs) can be accessed by a Workflow Manager or Team Leader. It provides reports on pending case versions, that is case versions currently being processed in the workflow and not yet locked.
This dashboard includes the following prompt, which is common to all its pages:
Enterprise ID: Lists the unique identifier for the enterprise.
This dashboard includes the following tabbed pages:
This page displays reports on the volume of pending case versions. This page includes the following prompts, which are common to all its reports:
Case Processing Site: Lists the name of the case processing site.
Country of Incidence: Lists the country of incidence.
Case Seriousness: Lists the seriousness level for the case.
Gender: Lists the gender of the patient reported in the case.
Age Group: Lists the age group of the patient reported in the case.
Product Name: Lists the product name in the case.
State Name: Lists the state name in the case.
Routing User Group: Lists the name of the routing user group in the case.
Lock Due Date Between: Lists the date range for the due date for case lock.
This page includes the following reports:
This page displays reports on the lock compliance of pending case versions, that is whether cases can still be locked on time or not. This page includes the following prompts, which are common to all its reports:
Case Processing Site: Lists the name of the case processing site.
Country of Incidence: Lists the country of incidence.
Case Seriousness: Lists the seriousness level for the case.
Gender: Lists the gender of the patient reported in the case.
Age Group: Lists the age group of the patient reported in the case.
Product Name: Lists the product name in the case.
State Name: Lists the state name in the case.
Routing User Group: Lists the name of the routing user group in the case.
Lock Due Date Between: Lists the date range for the due date for case lock.
This page includes the following reports:
This page displays reports on the workflow state compliance of pending case versions, that is whether workflow states can still be completed on time or not. This page includes the following prompts, which are common to all its reports:
Case Processing Site: Lists the name of the case processing site.
Country of Incidence: Lists the country of incidence.
Case Seriousness: Lists the seriousness level for the case.
Gender: Lists the gender of the patient reported in the case.
Age Group: Lists the age group of the patient reported in the case.
Product Name: Lists the product name in the case.
State Name: Lists the state name in the case.
Routing User Group: Lists the name of the routing user group in the case.
Lock Due Date Between: Lists the date range for the due date for case lock.
This page includes the following reports:
This section describes the dashboard called Personal User Dashboard in OPVA.
This dashboard of both retrospective and current metrics (trailing and effective KPIs) can be accessed by an individual Case Processor. It provides reports on cases that the Case Processor has worked on in the past, as well as cases that are currently assigned to the Case Processor and his/her user group(s).
This dashboard includes the following prompt, which is common to all its pages:
Enterprise ID: Lists the unique identifier for the enterprise.
This dashboard includes the following tabbed pages:
This page displays reports on the locked case versions that have been worked on (in any workflow state prior to case lock) by the user who is viewing this page.
This page includes the following prompt, which is common to all its reports:
Product Name: Lists the product name in the case.
This page includes the following reports:
This page displays reports on the cases that are currently assigned to the user who is viewing this page, as well as cases assigned to the group(s) to which that user belongs.
This page includes the following prompts, which are common to all its reports:
Product Name: Lists the product name in the case.
Routing User Group: Lists the names of the routing user groups in the case.
This page includes the following reports:
OPVA includes the following reports:
To locate a report, you need to select a dashboard and access a page that contains the report.
This section describes the Completed Case Versions - Volume Overview report.
This report displays an overview of the volume of completed cases by product group. This report can be used to compare the number of cases by product group, and to drill down into product families and products. This indicates which products are creating the greatest case processing workload.
This section describes the Completed Case Versions - Volume Trend report.
This report displays the trend over time of the volume of completed cases by product group. This report can be used to compare the case volume trend over the last three months by product group, and to drill down into months, weeks and days as well as product families and products. This indicates if the case processing workload for certain products is increasing, decreasing, or remaining constant over time.
This section describes the Completed Case Versions - Line Listing report.
This report displays the trend over time of the lock compliance of completed cases. This report can be used to view the lock compliance trend over the last three months and to drill down into months, weeks and days. This indicates if lock compliance is increasing, decreasing, or remaining constant over time.
Case Processing History dashboard > Case Processing Volume History page
Case Processing History dashboard > Case Processing Compliance History page
Case Processing History dashboard > Case Processing Repetition History page
Completed Case Versions - Volume Overview
Completed Case Versions – Volume Trend
Completed Case Versions – Lock Compliance Overview
Table A-3 describes the columns in the Completed Case Versions – Line Listing report:
Table A-3 Completed Case Versions – Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
ID |
Case.ID |
|
Case |
Version ID |
Case.Version ID |
|
Case Version |
Version Type |
Case Version.Version Type |
|
Case Version |
Case Processing Site |
Case Version.Case Processing Site |
|
Case Version |
Case Type |
Case Version.Case Type |
|
Case Version |
Case Seriousness |
Case Version.Case Seriousness |
|
Case Version |
Case Listedness |
Case Version.Case Listedness |
|
Case Version |
Case Causality |
Case Version.Case Causality |
|
Case Version |
SUSAR |
Case Version.SUSAR |
|
Case Version |
Initial Receipt Date |
Case Version.Initial Receipt Date |
|
Case Version |
Clock Start Date |
Case Version.Clock Start Date |
|
Case Version |
Lock Timestamp |
Case Version.Lock Timestamp |
|
Case Version |
Lock Due Date |
Case Version.Lock Due Date |
This section describes the Completed Case Versions - Lock Compliance Overview report.
This report displays an overview of the lock compliance of completed cases by case processing site. This report can be used to compare the retrospective lock compliance of case processing sites. This indicates which case processing sites might be having difficulties locking cases on time.
Table A-4 describes the columns in the Completed Case Versions - Lock Compliance Overview report:
Table A-4 Completed Case Versions - Lock Compliance Overview
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Case Processing Site |
Case Processing Site |
Case Processing Site.Case Processing Site |
|
Case Version |
# Versions Locked On-Time |
Case Version.# Versions Locked On-Time |
|
Case Version |
# Versions Locked Late |
Case Version.# Versions Locked Late |
This section describes the Completed Case Versions - Lock Compliance Proportion report.
This report displays the lock compliance of completed cases by percentage. This report can be used to compare the ratio of cases locked late to those locked on time.
Table A-5 describes the columns in the Completed Case Versions - Lock Compliance Proportion report:
Table A-5 Completed Case Versions - Lock Compliance Proportion
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Case Processing Site |
Case Processing Site |
Case Processing Site.Case Processing Site |
|
Case Version |
% Versions Locked On-Time |
Case Version.% Versions Locked On-Time |
|
Case Version |
% Versions Locked Late |
Case Version.% Versions Locked Late |
This section describes the Completed Case Versions - Lock Compliance Trend report.
This report displays the trend over time of the lock compliance of completed cases. This report can be used to view the lock compliance trend over the last three months and to drill down into months, weeks and days. This indicates if lock compliance is increasing, decreasing, or remaining constant over time.
Table A-6 describes the columns in the Completed Case Versions - Lock Compliance Trend report:
Table A-6 Completed Case Versions - Lock Compliance Trend
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Case Version - Version Receipt Date |
Year |
Period.Case Version - Version Receipt Date.Year |
|
Case Version |
# Versions Locked On-Time |
Case Version.# Versions Locked On-Time |
|
Case Version |
# Versions Locked Late |
Case Version.# Versions Locked Late |
This section describes the Completed Workflow States - Line Listing report.
This report lists the completed cases by Case ID including workflow states that were completed in each version of each case. This report can be used to drill down to the workflow states of the completed cases. This indicates which workflow states can be targeted for a root cause analysis, e.g. an investigation of cases that were locked late.
Case Processing History dashboard > Case Processing Volume History page
Case Processing History dashboard > Case Processing Compliance History page
Case Processing History dashboard > Workflow State Repetition History page
You can also navigate to this report from the following report:
Table A-7 describes the columns in the Completed Workflow States - Line Listing report:
Table A-7 Completed Workflow States - Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
ID |
Case.ID |
|
Case |
Version ID |
Case.Version ID |
|
State.Case Workflow - State |
State Name |
State.Case Workflow - State.State Name |
|
Case Workflow - State |
Duration State-Start-To-End |
Case Workflow - State.Duration State-Start-To-End |
|
Case Workflow - State |
Duration Within State |
Case Workflow - State.Duration Within State |
|
Case Workflow - State |
# Times State Repeated |
# Repeated States |
This section describes the Completed Case Version Routing - Line Listing report.
This report lists the completed cases by Case ID including routing between workflow states that were completed in each version of each case. This report can be used to drill down to the workflow state routing information of the completed cases. This indicates which routings can be targeted for a root cause analysis, e.g. an investigation of cases that were locked late.
Case Processing History dashboard > Case Processing Compliance History page
Case Processing History dashboard > Workflow State Repetition History page
Enterprise.Enterprise ID
State.Case Routing - State
User Group.Case Routing - Routing User Group
User.Case Routing - Routing User
You can also navigate to this report from the following report:
Table A-8 describes the columns in the Completed Case Version Routing - Line Listing report:
Table A-8 Completed Case Version Routing - Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
ID |
Case.ID |
|
Case |
Version ID |
Case.Version ID |
|
State.Case Routing - State |
State Routed From |
State.Case Routing - State.State Routed From |
|
State.Case Routing - State |
State Routed To |
State.Case Routing - State.State Routed To |
|
Case Routing |
Routing Timestamp From State |
Case Routing.Routing Timestamp From State |
|
Case Routing |
Routing Timestamp To State |
Case Routing.Routing Timestamp To State |
|
Case Routing |
Routing Justification |
Case Routing.Routing Justification |
|
User Group.Case Routing - Routing User Group |
Routing User Group |
User Group.Case Routing - Routing User Group.Routing User Group |
|
User.Case Routing - Routing User |
Routing User ID |
User.Case Routing - Routing User.Routing User ID |
This section describes the Repeated Workflow States - Volume Overview report.
This report displays an overview of the workflow state repetition of completed case versions. This report can be used to highlight which workflow states have been repeated within a single case version. Repetition can be an indicator of case quality (returned for rework) as well as new follow-up information being added to a case version (returned for additional data entry).
This section describes the Repeated Workflow States - Volume Proportion report.
This report displays the workflow state repetition of completed case versions by percentage. This report can be used to compare the ratio of workflow states have been repeated within a single case version. Repetition can be an indicator of case quality (returned for rework) as well as new follow-up information being added to a case version (returned for additional data entry).
Drug Safety Manager
Drug Safety Team Leader
Pharmacovigilance Executive Management
This section describes the Pending Cases - Volume Overview report.
This report displays an overview of the volume of pending cases by user group.This report can be used to compare the current, real-time workloads of the user groups that are processing cases. This indicates where immediate action could be taken to balance the workload among the groups if necessary.
Drug Safety Manager
Drug Safety Team Leader
Pharmacovigilance Executive Management
This section describes the Pending Cases - Line Listing report.
This report displays an overview of the lock compliance of pending cases by number of days until case lock is due and number of days that case lock is overdue.
This report can be used to compare the volumes of cases due on each day. This indicates where to focus resources in order to lock cases on time.
Drug Safety Manager
Drug Safety Team Leader
Pharmacovigilance Executive Management
Case Processing Management dashboard > Case Processing Volume Management page
Case Processing Management dashboard > Case Processing Compliance Management page
Case Processing Management dashboard > Workflow State Compliance Management page
Enterprise.Enterprise ID
User Group.Pending Cases - Routing User Group
User.Pending Cases - Assigned User
Pending Cases – Volume Overview
Table A-12 describes the columns in the Pending Cases - Line Listing report:
Table A-12 Pending Cases - Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
Case ID |
Case.Case ID |
|
Pending Cases |
Follow-Up ID |
Pending Cases.Follow-up ID |
|
Pending Cases |
Follow-Up Type |
Pending Cases.Follow-up Type |
|
Pending Cases |
Case Processing Site |
Pending Cases.Case Processing Site |
|
Pending Cases |
Case Type |
Pending Cases.Case Type |
|
Pending Cases |
Study ID |
Pending Cases.Study ID |
|
Pending Cases |
Case Seriousness |
Pending Cases.Case Seriousness |
|
Pending Cases |
Case Listedness |
Pending Cases.Case Listedness |
|
Pending Cases |
Case Causality |
Pending Cases.Case Causality |
|
Pending Cases |
Case Outcome |
Pending Cases.Case Outcome |
|
Pending Cases |
SUSAR |
Pending Cases.SUSAR |
|
Pending Cases |
Lock Due Soon Date |
Pending Cases.Lock Due Soon Date |
|
Pending Cases |
Lock Due Date |
Pending Cases.Lock Due Date |
|
User.Pending Cases - Assigned User |
Assigned User ID |
User.Pending Cases - Assigned Cases.Assigned User ID |
|
Pending Cases |
User with Case Open ID |
Pending Cases.User with Case Open ID |
|
Pending Cases |
State Name |
Pending Cases.State Name |
|
Pending Cases |
Routing ID |
Pending Cases.Routing ID |
|
UserGroup.Pending Cases - Routing User Group |
Routing User Group |
UserGroup.Pending Cases - Routing User Group.Routing User Group |
|
Pending Cases |
Routing Timestamp |
Pending Cases.Routing Timestamp |
|
Pending Cases |
Routing Justification |
Pending Cases.Routing Justification |
This section describes the Pending Cases - Lock Compliance Overview report.
This report displays an overview of the lock compliance of pending cases by user group. This report can be used to compare the current, real-time lock compliance of the user groups that are processing cases. This indicates where immediate action could be taken to balance the workload among the groups, if necessary.
Drug Safety Manager
Drug Safety Team Leader
Pharmacovigilance Executive Management
Table A-13 describes the columns in the Pending Cases - Lock Compliance Overview report:
Table A-13 Pending Cases - Lock Compliance Overview
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Pending Cases - Routing User Group |
Routing User Group |
User Group.Pending Cases - Routing User Group.Routing User Group |
|
Pending Cases |
# Unlocked Cases On-Time |
Pending Cases.# Unlocked Cases On-Time |
|
Pending Cases |
# Unlocked Cases Due Soon |
Pending Cases.# Unlocked Cases Due Soon |
|
Pending Cases |
# Unlocked Cases Overdue |
Pending Cases.# Unlocked Cases Overdue |
This section describes the Pending Cases - Lock Compliance In Days report. This report displays an overview of the lock compliance of pending cases by number of days until case lock is due and number of days that case lock is overdue.
This report can be used to compare the volumes of cases due on each day. This indicates where to focus resources in order to lock cases on time.
Drug Safety Manager
Drug Safety Team Leader
Pharmacovigilance Executive Management
Table A-14 describes the columns in the Pending Cases - Lock Compliance In Days report:
Table A-14 Pending Cases - Lock Compliance In Days
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Pending Cases |
> +5 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
+5 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
+4 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
+3 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
+2 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
+1 Day |
Pending Cases.Lock Due Date |
|
Pending Cases |
0 Day |
Pending Cases.Lock Due Date |
|
Pending Cases |
-1 Day |
Pending Cases.Lock Due Date |
|
Pending Cases |
-2 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
-3 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
-4 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
-5 Days |
Pending Cases.Lock Due Date |
|
Pending Cases |
> -5 Days |
Pending Cases.Lock Due Date |
This section describes the Pending Workflow States - Compliance Overview report.
This report displays an overview of the compliance of pending cases by workflow state. This report can be used to highlight the current, real-time workflow state compliance of pending cases. This indicates where to focus resources in order to complete workflow states on time, which in turn can help to ensure that cases are later locked on time.
Drug Safety Manager
Drug Safety Team Leader
Pharmacovigilance Executive Management
Table A-15 describes the columns in the Pending Workflow States - Compliance Overview report:
Table A-15 Pending Workflow States - Compliance Overview
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Pending Cases |
State Name |
Pending Cases.State Name |
|
Pending Cases |
# Unlocked Cases On-Time |
Pending Cases.# Unlocked Cases On-Time |
|
Pending Cases |
# Unlocked Cases Due Soon |
Pending Cases.# Unlocked Cases Due Soon |
|
Pending Cases |
# Unlocked Cases Overdue |
Pending Cases.# Unlocked Cases Overdue |
This section describes the My Completed Workflow States – Volume Trend report.
This report displays the trend over time of the volume of workflow states that have been completed by the user who is viewing this report.
This report can be used to highlight the user's personal workflow state volume trend over the last three months. This indicates if the user's personal workload is increasing, decreasing, or remaining constant over time.
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
This section describes the My Repeated Workflow States – Volume Overview report.
This report displays an overview of the workflow states that have been repeated by the user who is viewing this report. This report can be used to highlight which workflow states have been repeated by the viewing user within a single case version. Repetition can be an indicator of case quality (returned for rework) as well as new follow-up information being added to a case version (returned for additional data entry).
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
This section describes the My Completed Case Versions – Line Listing report.
This report lists the locked case versions that have been worked on (in any workflow state prior to case lock) by the user who is viewing this report.
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
Table A-22 describes the columns in the My Completed Case Versions – Line Listing report:
Table A-18 My Completed Case Versions – Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
ID |
Case.ID |
|
Case |
Version ID |
Case.Version ID |
|
Case Version |
Version Type |
Case Version.Version Type |
|
Case Version |
Case Processing Site |
Case Version.Case Processing Site |
|
Case Version |
Case Type |
Case Version.Case Type |
|
Case Version |
Case Seriousness |
Case Version.Case Seriousness |
|
Case Version |
Case Listedness |
Case Version.Case Listedness |
|
Case Version |
Case Causality |
Case Version.Case Causality |
|
Case Version |
SUSAR |
Case Version.SUSAR |
|
Case Version |
Initial Receipt Date |
Case Version.Initial Receipt Date |
|
Case Version |
Clock Start Date |
Case Version.Clock Start Date |
|
Case Version |
Lock Timestamp |
Case Version.Lock Timestamp |
|
Case Version |
Lock Due Date |
Case Version.Lock Due Date |
This section describes the My Completed Workflow States – Line Listing report.
This report lists the completed workflow states of the locked case versions that have been worked on (in any workflow state prior to case lock) by the user who is viewing this report.
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
Table A-23 describes the columns in the My Completed Workflow States – Line Listing report:
Table A-19 My Completed Workflow States - Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
ID |
Case.ID |
|
Case |
Version ID |
Case.Version ID |
|
State.Case Workflow - State |
State Name |
State.Case Workflow - State.State Name |
|
Case Workflow - State |
Duration State-Start-To-End |
Case Workflow - State.Duration State-Start-To-End |
|
Case Workflow - State |
Duration Within State |
Case Workflow - State.Duration Within State |
|
Case Workflow - State |
# Times State Repeated |
# Repeated States |
This section describes the My Pending Cases - Overview report.
The report displays an overview of the volume of cases that are currently assigned to the user who is viewing this report (My Assigned Cases), the cases that are assigned to the group(s) to which that user belongs but not to any individual users (My Unassigned Cases), and the cases that are assigned to other users in the group(s) to which the viewing user belongs (Other Assigned Cases).
This report can be used to highlight the current, real-time workload of the user viewing this report, the pool of cases that need to be worked on next (upcoming workload), and the workload of the viewing user's colleagues (potential workload if cases are reassigned). Therefore the user has a complete overview of his/her current, upcoming and potential workloads.
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
Table A-16 describes the columns in the My Pending Cases - Overview report:
Table A-20 My Pending Cases - Overview
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Pending Cases |
# My Assigned Cases |
User.Pending Cases - Assigned User.Assigned User ID |
|
Pending Cases |
# My Unassigned Cases |
User.Pending Cases - Assigned User.Assigned User ID |
|
Pending Cases |
# Other Assigned Cases |
User.Pending Cases - Assigned User.Assigned User ID |
|
Pending Cases |
Total Cases |
Cases.Case ID |
This section describes the My Assigned Cases - Line Listing report.
This report lists the cases that are currently assigned to the user who is viewing this report.
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
Enterprise.Enterprise ID
User Group.Pending Cases - Routing User Group
User.Pending Cases - Assigned User
Table A-17 describes the columns in the My Assigned Cases - Line Listing report:
Table A-21 My Assigned Cases - Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
Case ID |
Case.Case ID |
|
Pending Cases |
Follow-Up ID |
Pending Cases.Follow-up ID |
|
Pending Cases |
Follow-Up Type |
Pending Cases.Follow-up Type |
|
Pending Cases |
Case Processing Site |
Pending Cases.Case Processing Site |
|
Pending Cases |
Case Type |
Pending Cases.Case Type |
|
Pending Cases |
Study ID |
Pending Cases.Study ID |
|
Pending Cases |
Case Seriousness |
Pending Cases.Case Seriousness |
|
Pending Cases |
Case Listedness |
Pending Cases.Case Listedness |
|
Pending Cases |
Case Causality |
Pending Cases.Case Causality |
|
Pending Cases |
Case Outcome |
Pending Cases.Case Outcome |
|
Pending Cases |
SUSAR |
Pending Cases.SUSAR |
|
Pending Cases |
Lock Due Soon Date |
Pending Cases.Lock Due Soon Date |
|
Pending Cases |
Lock Due Date |
Pending Cases.Lock Due Date |
|
User.Pending Cases - Assigned User |
Assigned User ID |
User.Pending Cases - Assigned Cases.Assigned User ID |
|
Pending Cases |
User with Case Open ID |
Pending Cases.User with Case Open ID |
|
Pending Cases |
State Name |
Pending Cases.State Name |
|
UserGroup.Pending Cases - Routing User Group |
Routing User Group |
UserGroup.Pending Cases - Routing User Group.Routing User Group |
|
Pending Cases |
Routing Timestamp |
Pending Cases.Routing Timestamp |
|
Pending Cases |
Routing Justification |
Pending Cases.Routing Justification |
This section describes the My Unassigned Cases - Line Listing report.
This report lists the cases that are assigned to the group(s) to which the viewing user belongs but not to any individual users.
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
Enterprise.Enterprise ID
User Group.Pending Cases - Routing User Group
User.Pending Cases - Assigned User
Table A-18 describes the columns in the My Unassigned Cases - Line Listing report:
Table A-22 My Unassigned Cases - Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
Case ID |
Case.Case ID |
|
Pending Cases |
Follow-Up ID |
Pending Cases.Follow-up ID |
|
Pending Cases |
Follow-Up Type |
Pending Cases.Follow-up Type |
|
Pending Cases |
Case Processing Site |
Pending Cases.Case Processing Site |
|
Pending Cases |
Case Type |
Pending Cases.Case Type |
|
Pending Cases |
Study ID |
Pending Cases.Study ID |
|
Pending Cases |
Case Seriousness |
Pending Cases.Case Seriousness |
|
Pending Cases |
Case Listedness |
Pending Cases.Case Listedness |
|
Pending Cases |
Case Causality |
Pending Cases.Case Causality |
|
Pending Cases |
Case Outcome |
Pending Cases.Case Outcome |
|
Pending Cases |
SUSAR |
Pending Cases.SUSAR |
|
Pending Cases |
Lock Due Soon Date |
Pending Cases.Lock Due Soon Date |
|
Pending Cases |
Lock Due Date |
Pending Cases.Lock Due Date |
|
User.Pending Cases - Assigned User |
Assigned User ID |
User.Pending Cases - Assigned Cases.Assigned User ID |
|
Pending Cases |
User with Case Open ID |
Pending Cases.User with Case Open ID |
|
Pending Cases |
State Name |
Pending Cases.State Name |
|
UserGroup.Pending Cases - Routing User Group |
Routing User Group |
UserGroup.Pending Cases - Routing User Group.Routing User Group |
|
Pending Cases |
Routing Timestamp |
Pending Cases.Routing Timestamp |
|
Pending Cases |
Routing Justification |
Pending Cases.Routing Justification |
This section describes the Other Assigned Cases - Line Listing report.
This report lists the cases that are assigned to other users in the group(s) to which the viewing user belongs.
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
Enterprise.Enterprise ID
User Group.Pending Cases - Routing User Group
User.Pending Cases - Assigned User
Table A-19 describes the columns in the Other Assigned Cases - Line Listing report:
Table A-23 Other Assigned Cases - Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
Case ID |
Case.Case ID |
|
Pending Cases |
Follow-Up ID |
Pending Cases.Follow-up ID |
|
Pending Cases |
Follow-Up Type |
Pending Cases.Follow-up Type |
|
Pending Cases |
Case Processing Site |
Pending Cases.Case Processing Site |
|
Pending Cases |
Case Type |
Pending Cases.Case Type |
|
Pending Cases |
Study ID |
Pending Cases.Study ID |
|
Pending Cases |
Case Seriousness |
Pending Cases.Case Seriousness |
|
Pending Cases |
Case Listedness |
Pending Cases.Case Listedness |
|
Pending Cases |
Case Causality |
Pending Cases.Case Causality |
|
Pending Cases |
Case Outcome |
Pending Cases.Case Outcome |
|
Pending Cases |
SUSAR |
Pending Cases.SUSAR |
|
Pending Cases |
Lock Due Soon Date |
Pending Cases.Lock Due Soon Date |
|
Pending Cases |
Lock Due Date |
Pending Cases.Lock Due Date |
|
User.Pending Cases - Assigned User |
Assigned User ID |
User.Pending Cases - Assigned Cases.Assigned User ID |
|
Pending Cases |
User with Case Open ID |
Pending Cases.User with Case Open ID |
|
Pending Cases |
State Name |
Pending Cases.State Name |
|
UserGroup.Pending Cases - Routing User Group |
Routing User Group |
UserGroup.Pending Cases - Routing User Group.Routing User Group |
|
Pending Cases |
Routing Timestamp |
Pending Cases.Routing Timestamp |
|
Pending Cases |
Routing Justification |
Pending Cases.Routing Justification |
This section describes the My Completed Case Version Routing – Line Listing report.
This report lists the workflow state routing information of the locked case versions that have been worked on (in any workflow state prior to case lock) by the user who is viewing this report.
Drug Safety Data Entry Personnel
Drug Safety Medical Assessment Physician
Drug Safety Quality Reviewer
Drug Safety and Surveillance Specialist
Enterprise.Enterprise ID
State.Case Routing - State
User Group.Case Routing - Routing User Group
User.Case Routing - Routing User
Table A-24 describes the columns in the My Completed Case Version Routing – Line Listing report:
Table A-24 My Completed Case Version Routing - Line Listing
| Table Heading | Column Heading | Measure |
|---|---|---|
|
Enterprise |
Enterprise ID |
Enterprise.Enterprise ID |
|
Case |
ID |
Case.ID |
|
Case |
Version ID |
Case.Version ID |
|
State.Case Routing - State |
State Routed From |
State.Case Routing - State.State Routed From |
|
State.Case Routing - State |
State Routed To |
State.Case Routing - State.State Routed To |
|
Case Routing |
Routing Timestamp From State |
Case Routing.Routing Timestamp From State |
|
Case Routing |
Routing Timestamp To State |
Case Routing.Routing Timestamp To State |
|
Case Routing |
Routing Justification |
Case Routing.Routing Justification |
|
User Group.Case Routing - Routing User Group |
Routing User Group |
User Group.Case Routing - Routing User Group.Routing User Group |
|
User.Case Routing - Routing User |
Routing User ID |
User.Case Routing - Routing User.Routing User ID |
|
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|
