Eight Best Practices For Compliant Essential Site Regulatory Documents

By Patrice Pompa, Director, Regulatory Document Management Services and Kevin T. Williams, MBA, MS, Vice President, Corporate Development and Marketing, CFS Clinical

In the push to initiate clinical trials, activating sites is understandably the primary focus—leaving essential site regulatory documents as a secondary priority and a bit of a “necessary evil.” Indeed, most sponsors and CROs approach essential site regulatory documents as a check-the-box exercise. Even though resource-constrained sites sometimes rush through completion and submission of documents, sponsors and CROs do not always perform thorough reviews and quality assurance. The result: missing information, inaccurate data, and overall inconsistency in the quality of documents and data management.

This approach may seem sufficient—until an audit, which may occur years later, reveals issues in the original paperwork. An eleventh-hour audit creates a great deal of pain for those left to tidy up the mess. In some case, such “messes” can even lead to delays in bringing new products to market.

While it may be disingenuous to suggest that essential site regulatory documents will ever be more than a burdensome chore required to get studies initiated, here are proven best practices for managing this clinical trial business process with greater efficiency and effectiveness: