The SDTM annotated CRF (aCRF) is a cumbersome submission document to create. It’s also highly important. It visually documents how data are mapped from the CRF to SDTM. Because this is mostly a manual task, it is key to know what makes a high-quality aCRF.
In this webinar, Amy Garrett reviews published guidance from regulatory agencies and provides best practices for CRF annotations. These practices ensure your aCRF meets current regulatory requirements and the needs of internal users.
More Resources- Download the Slide Deck
- Read the Q&A below
Answers to Your Questions
We received over 200 follow-up questions from you. That’s a lot of questions! So we decided to group them into the categories below and answer them in our upcoming blog posts. As new posts are published, they will be linked below, so check back soon.
- Annotation formatting
- Document properties, bookmarking and table of contents
- Multiple copies and/or multiple versions of forms
- Not Submitted annotations and SDRG
- Creation and validation of aCRF
- External data (diaries, ePRO, etc.)
- Specific examples - How is this annotated?
- Specific examples - Should this be annotated?