Manage episode 260804366 series 2665030
#011 - 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.