Common Audit Findings_Source Docs and Subject Eligibility
Manage episode 260804369 series 2665030
#008 - 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 am discussing the importance of complete source documentation and verification of subject eligibility. A subject that is randomized to study drug, and not truly eligible for the study, can risk a subject’s safety and the efficacy data of a trial. Join me, as I share some experiences from my own monitoring journey, as well as, helpful tips for CRA review.
21 פרקים