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Table of Contents

Summary

Note

We are trying something new. This format and presentation of information in this article is experimental. We intended to help users get the best from our standard reports / exports and dashboard components. What we include and how we present it may change over time. We welcome feedback on this article and contents via our service desk portal.

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.

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titleVersion

View Script

6f65487c8e25f70d91f81161f4076e80

Data Script

b9d368214f8600592f61d2efd26c6316

Data Script Template

dedba6712b1caacb999d279af5beeae1

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titleReleased

Commit

Date

Merged

8df14a

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

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Tip

This report is expected to pass validation using https://www.lorenz.cc/Solutions/eValidator-BASIC/. Exceptions are listed below.

  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.