Good documentation practices can make or break a clinical trial’s success. The saying goes, “if it is not clearly documented, it did not happen.” The revision of ICH E6 GCP (R2 Addendum) brought with it some updates to GCP definitions that provide very important clarity. Among those are descriptions of good documentation practices related to what constitutes quality study regulatory and subject source documentation, irrespective of the type of media used. Site documentation practices have significant variability in the interpretation of what is required as acceptable, (e.g., providing the sponsor with the original source document vs. a copy). Even so, not everything in the updated Guideline is clear.
Come to this 60-minute, interactive live session and you will:
- Receive a checklist to assess the adequacy of documentation.
- Practice applying ALCOA-C to paper and electronic documentation in the post ICH GCP E6 (R2) world.
- Identify methods to assess quality documentation to support inspection of clinical trials, no matter the media.
- Recognize appropriate ways to address deficiencies in documentation.