Prepare content for a Clinical Trial Periodic Report
The Clinical Trial Periodic Reports (CTPR) are created to report the IND Annual reports and EU Clinical Trial Directive line listing reports to FDA.
For more information, see:
- Create a Clinical Trial Periodic Report
- Enter common fields information
- Configure subject in the report header
- Select products to include in CTPR
- Configure license or study in the report header
- Select inclusion criteria
- Use the Data Lock Point (DLP) version
- Use DLP queries for dates
- Use As of Reporting function
- Find DLP and As of Query functionality
- Include line listing
- Add data elements
- View selected data elements
- Group cases
- Specify summary tabulations for line listing
- Generate single case submission report
- Select summary listing
- Schedule the report
- Setup frequency of the scheduled reports
- Configure security level of the report
- Use report templates
Parent topic: Prepare content for periodic reports