Common Audit Findings_Source Docs and Subject Eligibility

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Let's Get Clinical, Tips From The CRA Helper

Miscellaneous


#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 monitoring journey, as well as, helpful tips for CRA review.