Guidelines for Development and Maintenance of Regulatory Files/Binders

SOP #: PM-6

Next Review Date: 12/2004

Version #: 1.2

Review Interval Period: Biennial

Approved Version #: 1.3 Date: 12/2003

Policy Reference: REG-2

Purpose: To provide direction for the development and maintenance of regulatory files/binders.
STEP 1: Develop Regulatory Files/Binders for Each Study
  1. For each study that is activated, a file folder or binder is created for essential regulatory documents collected during the study to ensure compliance with Federal regulatory guidelines and principles of GCP.
  2. For all studies, all original documents and any subsequent versions should be maintained in this file/binder for the duration of the study and for the designated regulatory time requirement (i.e., FDA, ICH/GCP) post study.
  3. Ensure that all documents in regulatory files/binders are maintained in a secure, limited-access location and are kept confidential to ensure conformity to principles of confidentiality and human subjects protections.
  4. The following documents (all versions) should be collected and filed in the regulatory file/binder if applicable to the clinical trial: (ref: ICH/GCP):