The annual ACRP meeting will be held April 12th – 15th, 2019 at the Nashville Music City Center in Nashville, TN. This meeting brings together clinical research personnel from various backgrounds and provides them with the opportunity to share their expertise as well as obtain knowledge across the clinical research landscape. IMARC will be presenting on Sunday, April 14th, from 3:15 – 4:15 on identifying, documenting, and implementing corrective action plans to improve site compliance from a CRO perspective.
This session will provide an overview on how to appropriately identify, document, and address compliance issues noted at sites, from monitoring and Sponsor perspectives. There will be an overview of common monitor findings and a discussion about appropriate next steps for developing effective CAPAs. The escalation of issues to the Sponsor will be discussed along with how to adequately document compliance issues in monitoring reports and follow-up letters. Possible ways in which the Sponsor can handle noncompliances will be addressed, as well as the consequences and risks to the Sponsor and study if compliance issues are not addressed. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.
We are excited for the opportunity to speak on this topic and share the experience we’ve gained by working on a variety of studies with many Sponsors throughout the years. Please let us know if you plan on attending or would like to know more about this topic!