Join us for a discussion on one of the most difficult tasks within clinical research. ACRP’s Editor-in-Chief, Michael Causey, will chat with Chris Gantz, Senior Director at Sidney Kimmel Cancer Center, about an approach that has been successful for him and his team.
We invite all CRCs, CRAs, Project Managers, Regulatory Liaisons, and other study personnel to join this webinar for a review of our responsibilities and a discussion of these relationship. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and open forum for discussion provided.
This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions.
This session will provide an overview on how to appropriately identify, document and address compliance issues noted at sites, from monitoring and Sponsor perspectives. 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.
The key to a successful inspection is preparing at the start of the study. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings