Common Audit Findings Missing or Incomplete Essential Documents - Delegation Log

- Learning the common audit findings is so beneficial for a CRA. It can serve as a reminder of what to look for and serves as a helpful tool in order to prevent them. This week, I discuss issues associated with missing/incomplete essential documentation. This documentation is so important and is a requirement per GCPs as they permit evaluation of the conduct of a study and the quality of the data produced. Remember, in addition to subject safety, one of our primary obligations as a CRA is to ensure data integrity and quality. Essential documents demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. The Investigator Site File, aka Regulatory Binder, and the TMF, should be audit ready at all times. In this particular episode I focus on the Delegation of Authority Log and training documentation. Join me, as I share some helpful tips for successful Reg Binder review.

You can listen to Common Audit Findings Missing or Incomplete Essential Documents - Delegation Log online on Radio and Podcast. Open the player on this page to stream the available audio.

Common Audit Findings Missing or Incomplete Essential Documents - Delegation Log is an episode from Let's Get Clinical, Tips From The CRA Helper by Elizabeth.

This episode is 13:53 long.

This episode was published on Mar 10, 2020.

Yes. Use the heart button on the episode page to add it to your favorite episodes list.

Yes. This page shows related episodes from Let's Get Clinical, Tips From The CRA Helper when more episodes are available from the podcast feed.