Protocol Information Management System Regulator Binder: Streamlining Regulatory Binder Documentation Maintenance and Improving Compliance


Description of the Research

A regulatory binder is defined as a file that contains all clinical research study specific and regulatory information. A regulatory binder organizes essential regulatory documents and provides easy access to trial monitors, auditors, IRB/PB and/or any regulatory authorities to pertinent study information. In an effort to streamline regulatory documentation processes across departments, our Center’s Office of Clinical Research decided to create an electronic regulatory binder. Currently, we utilize an in house developed paper management system known as the Protocol Information Management System (PIMS) for the protocol review process. It was decided to further leverage our capabilities in PIMS to include our protocol regulatory binders. Prior to the implementation of the PIMS regulatory binder, the storage of regulatory documents were either in paper binders or electronically on a network drive. The objective of the PIMS regulatory binder is to maintain compliance with federal requirements and regulations, standardize document filing management and nomenclature, simplify access for external monitors/auditors and also return time and effort to the local research study assistant.

A thorough review was conducted to ensure all pertinent regulatory binder documents would flow from the PIMS IRB/PB protocol document folders directly into the designated study specific regulatory binder section and to ensure electronic sub folders were created to capture non IRB/PB related documents. Lastly, educational tools were created for our clinical research community to ease the transition from their previous practices. 

This poster will outline the methods used to create the PIMS regulatory binder, the educational materials for training staff on the new format, identified future enhancements, and how it has thus far improved regulatory documentation and compliance across our clinical departments.