Summary

The FDA expects pharmaceutical companies to provide the completed Case Report Forms (CRFs) as part of the electronic FDA submission package. The ClinSpark Completed CRF provides customers with CRFs that comply with the FDA’s requirements for PDF documents.

Compatibility

Standards

The following standards have been followed:

1. https://www.fda.gov/media/76797/download

Industry Guidance

The following industry guidance has been followed where possible and appropriate:

1. https://www.pinnacle21.com/blog/formatting-annotated-case-report-forms

2. https://www.pinnacle21.com/blog/formatting-annotated-case-report-forms-part2

Recent Changes

Key changes. May not include minor changes.

1. Fonts updated to be in the 9-12 points range

2. Margin at least 3/4" of left and 3/8" on other sides but header/footer should not appear within 3/8”.

3. For landscape orientation, the margin of 3/4" at the top allows a more legible display of information

4. Study Events have been renamed as Visits

5. Dates follow the pattern ddMMMyyyy HH:mm:ss and are consistent with the web application

6. Added a Form based Table of Contents

7. Title of the document is now "crf-[study number]-[site number]-[subject identifier]” in lower case

8. The subject is now identified by one selected identifier across the cover page and subsequent pages. Lead-in numbers are not displayed by default

9. The filename is configurable and defaults to screening number

10. Inherit Zoom is supported across all properly bookmarked PDFs

11. The default Visits Table of Contents can be configured not to display

12. In the case of multiple AEs, bookmarks can be set to point only to the first AE

13. Where available, timepoints are added to the Visits bookmarks

14. Bookmarks are collapsed by default

15. Subject Over Volunteering page can be set not to display

16. Visits are displayed in the PDF in the order they are displayed in the user interface

Configuration Requirements

The behaviour of the Completed CRF report can be adjusted through system level configuration options available to IQVIA support staff.

Global Setting

System level configuration is through the use of a Global Setting with a key of CompletedCRFReportSettings. The setting value is in "JSON" format.

The use of configuration is perhaps best illustrated through examples. Firstly, consider a Global Setting value that configures the Sample CRF Report to hide the ‘code lists’ section:

{
"includeScreeningNumber":  true,
"includeLeadInNumber": false,
"filenameIncludesScreeningNumber": true,
"filenameIncludesLeadInNumber": false,
"filenameIncludesRandomizationNumber": false,
"displayVisitToc": true,
"displayFormToc": true,
"includeOverVolunteeringForm": false,
"onlyDisplayFirstAePerVisit": false
}

Details

Available Settings

The available settings are as shown in the following table.

Other Output Drivers

Visit Names and Order

This is dictated by the names and sequence of Study Events in the Study Library…

Remember that Study Events can be dragged and dropped in the UI…

User Interface

The report can be accessed via the Study | Report menu once a study has been selected…

The report includes the ability to:

1. Include Non-CRF data

2. Include non-randomised subjects

3. Exclude Data Audit Trails

4. Exclude Review (signing, non-signing) information

5. Filter to given subjects

6. Display Item Names

Limitations / Restrictions

1. ClinSpark does not support a way to set the ‘fast web view’ setting. It’s likely that this will require a new version of ClinSpark

2. Depending on the viewer used to open the PDF output, bookmarks may be expanded when the document is first opened. Some viewers correctly present the bookmarks as closed

3. ClinSpark has no direct way to set the ‘inherit zoom’ property of the PDF output, but we believe that this works under typical conditions