Summary

The FDA expects pharmaceutical companies to provide the SDTM Annotated CRF (acrf.pdfcompleted Case Report Forms (CRFs) as part of the electronic FDA submission package. The ClinSpark Sample CRF (sometimes called Blank CRF) Completed CRF provides customers with a Case Report Form that complies CRFs that comply with the FDA’s requirements for PDF documents that can be marked up in order to create an Annotated CRF.

Compatibility

Standards

The following standards have been followed:

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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

1. Bookmarks have been updated based on the CDISC SDTM MSG 2.0 specification and modified to improve navigation

2. Following the CDISC guideline, a table of contents has been added within the report (old tables were removed) that reflect the same content as the bookmarks.

3. Added ability to hide sections of the report using system settings or item group aliases

4. Added support for special characters to the report (post ClinSpark 22.2), which means that the font changes to the Calibri font when running >=22.2

5. Fixed an issue that appeared when running the report when not selecting an Activity Plan

6. Fixed the linkage between forms and study events, correcting issues with common forms, unscheduled and subject forms

7. Fixed issues where forms that contained non-CRF data were appearing in the bookmarks (but not in the report itself) when you chose to only include CRF data

8. Fixed a bug in the handling of archived study events. Simplified logic to reduce the risk of these types of bugs

9. Fixed an issue that caused blank pages to appear if the table of contents exactly filled a page

Configuration Requirements

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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 behavior 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 “SampleCRFReportSettings” CompletedCRFReportSettings. The setting value is in “JSON” "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,
"includeCodeLists"displayVisitToc": true,
"displayFormToc": true,
"includeOverVolunteeringForm": false,
"onlyDisplayFirstAePerVisit": false
}

These settings must be created and updated by IQVIA support staff…

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Study Level

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Here’s an Item Group containing an alias to achieve the same effect…

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Details

Available Settings

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Other Output Drivers

Visit Names and Order

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

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

   1. You can edit PDFs in Acrobat Pro to set the ‘fast web view' option may be able to achieve this in bulk by using one of Adobe’s ‘actions’. See https://helpx.adobe.com/ie/acrobat/using/optimizing-pdfs-acrobat-pro.html

   2. Image Added

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.