In many ways, CRAs carry the world on their shoulders during a clinical trial. From the sponsor perspective, they are essentially the COO for the study site who ensures everything is running smoothly. Particularly, as it applies to site monitoring visits and the reconciliation process, where they are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s).
It is everyone’s job to maintain a culture of inspection readiness, but CRAs are responsible for finding and resolving any issues with subject source-data verification, TMF and ISF documentation, and CTMS reporting. In our global experience with CRAs in the field, they have consistently reported that the two biggest obstacles for them are:
Effective compliance requires fluidity in the process, and manual documentation cannot provide the fluid trail of tasks and actions that captures the full story of CRA site monitoring visits or allows CRAs to easily delegate to study teams.
It is imperative that these processes are automated and streamlined as much as possible. Instead of CRAs receiving a spreadsheet of missing, queried, and expired TMF documentation that is then converted into a task list that is then compared against their previous visit, they can have the whole story in one location. With cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience the following process improvements.