Join Advarra

Learn more about our company team, careers, and values. Join Advarra’s Talented team to take on engaging work in a dynamic environment.

See Jobs

The Regulatory Binder Checklist For Clinical Trial Sites

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team. Though not legally binding, maintaining a regulatory binder is highly recommended for all intervention trials. This checklist offers a comprehensive framework for managing all necessary documents efficiently.

Download a Printable Version of this Checklist


Terms Used Synonymously

Guidance Documents

For more information, you can download our eBook detailing good clinical practice (GCP) and its role in the clinical research ecosystem.

Centralization of Documents

When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

Essential Documents of a Regulatory Binder

These documents demonstrate the investigator’s, sponsor’s, and monitor’s compliance with GCP and regulatory requirements.

Streamline Regulatory Compliance with Advarra eReg

Advarra eReg simplifies the management of essential documents, ensuring your clinical trials remain compliant and organized. This system provides key benefits to binder management such as:

Download a Printable Version of this Checklist

Back to Resources