Best Practices For Paper-Based & eRegulatory Sites

This article examines the use of electronic tools for maintaining regulatory compliance at research sites, and recommends best practices to be applied to the use of those tools. The information presented here is based on observed practice and anecdotal evidence, as well as on data collected in various studies.

Regulatory Processes

The regulatory processes in play at research sites are based on a core set of GCP and FDA requirements, and on good documentation practices that, while required, are themselves not well documented. These include:

• Processing Amendments
• Reporting Events
• Reviewing Safety Reports
• Tracking Qualifications
• Documenting Training and Delegation
• Filing Correspondences
• Managing SOPs, FWAs, CLIAs

As research sites transition from smaller mom-and-pop organizations to mature research centers, these processes are evolving. Where each monitor or sponsor may have once wanted to approach these tasks in their own unique fashion, many sites now seek to inject more uniformity and efficiency into these processes in order to more readily achieve audit-ready regulatory compliance across all studies and sites. Those efforts are supported by both GCP and the FDA, and are the responsibility of the sites.