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Saturday, April 4, 2020 | 11:45 AM
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:
Adding to this already challenging situation, they often fly into a location to conduct two to three separate site monitoring visits across one or more studies in a matter of a few days. If they are spending hours digging through binders, these visits can become nightmares of time inefficiency and TMF anthropology.
Why are these essential processes so painful? Because, for many CRAs, these processes are still very much manual and executed on spreadsheets (or, in most cases, on paper). We have no axe to grind with our friend the spreadsheet—Excel is a powerful and useful tool. However, it isn’t the right tool for the job for CRAs, our heroes of investigative site compliance. 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 these process improvements:
With such immense responsibility, CRAs need every advantage to help their teams save time and reduce risks. To recap, here is what we can do for our CRAs with the right e-clinical approach:
Coming to DIA 2019 San Diego? Stop by Booth 1838 to experience the mobile reconciliation process for yourself.
To learn more about mobile eTMF contact us anytime at email@example.com.
A Step in the Right Direction for Clinical Trial Management: Improvements on the GCP E6(R3) ICH Harmonized Guidelines