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Note

We are trying something new. This format and presentation of information in this article is experimental and is . 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. Apologies in advance for any glitches!We welcome feedback on this article and contents via our service desk portal.

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.

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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.