Summary

The FDA expects pharmaceutical companies to provide the SDTM Annotated CRF (acrf.pdf) as part of the electronic FDA submission package. The ClinSpark Sample CRF (sometimes called Blank CRF) provides customers with a Case Report Form that complies 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:

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

Industry Guidance

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

1. Formatting Annotated Case Report Forms (aCRFs): Part 1 | Pinnacle 21

2. Formatting Annotated Case Report Forms (aCRFs): Part 2 | Pinnacle 21

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

The behavior of the Sample CRF Report can be adjusted through both system level and study level configuration options.

Global Setting

System level configuration is through the use of a Global Setting with a key of “SampleCRFReportSettings”. 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:

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

Open

Open

Study Level

System level settings can be overridden at the study level through the use of aliases assigned to an item group. Any item group can be used for storing the settings, but we suggest creating a group named ‘Sample CRF Report Settings’ to aid easily identifying settings within studies.

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

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…

Specific Activity Plans can be selected and Non-CRF data can be excluded where required.

Limitations / Restrictions

1. ClinSpark currently does not support a way to apply the ‘fast web view’ setting to 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 Optimizing PDFs

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.