Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Table of Contents

Summary

Note

We are trying something new. This article is experimental and is 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!

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.

...