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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.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.

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

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Setting Name

Description

Possible values

Default

includeCodeLists

Controls visibility of the Code Lists section, along with links from items to their associated code list.

true or false

true

includeUnitsOfMeasure

Controls visibility of the Units of Measure section.

true or false

true

includeLabPanels

Controls visibility of the Study Lab Panels section.

true or false

true

Other

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Output Drivers

Visit Names and Order

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

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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.