As much as conducting virtual or hybrid (onsite/offsite) clinical trials is still a whole new world that some traditional brick and mortar study sites are only beginning to explore, figuring out how to confirm if site principal investigators (PIs) are providing and documenting adequate oversight of such trials is all new for some study sponsors and contract research organizations (CROs).
An entire PI oversight plan was among other valuable tips and tactics for setting site leadership up for success in new ways of conducting trials provided by Adam Samson, MS, PMP, CCRA, CCRC, CCDM, vice president of clinical operations for Curebase, in a presentation at ACRP 2022 on Saturday (April 23). Designed for approval on a pre-study basis by both the PI and sponsor/CRO, the purpose of the plan is to “outline the process by which the study site PI will maintain oversight of all site staff who are delegated study-specific responsibilities” and to describe “the methods and expectations for site staff communication.”
After describing the roles of PIs and other clinical site staff, the plan explains the sponsor/CRO expectations regarding:
- Availability of a site staff contact list
- Delegation of responsibilities by the PI of certain study-related tasks to site staff assigned to the study and maintenance of a Delegation of Authority Log
- Site staff training, including documented training for each site staff member in Good Clinical Practice and Human Subjects Protection
- Ongoing oversight (The PI has the primary supervisory responsibility for the site staff and will provide ongoing guidance relating to the conduct of the study. The PI will review related reports, decisions, and documentation verifying actions taken for any responsibilities that have been delegated. PI supervision and oversight will be provided for all site staff, including those who are highly qualified and experienced.)
- Documentation of delegation, training, and oversight
- Site staff transitions (e.g., a change in PI or primary clinical research coordinator during a study)
Author: Gary Cramer
