Standard Operating Procedure for Managing the Investigator Site File

Purpose

This SOP outlines the procedures for maintaining the Investigator Site File (ISF) in clinical trials and clinical studies. The goal is to ensure that all essential documents are organized, up-to-date, and readily accessible for monitoring, auditing, and regulatory inspections.

Scope

This SOP applies to all personnel involved in managing and maintaining the Investigator Site File (ISF) for clinical trials and clinical studies, including principal investigators, clinical research coordinators, and study support staff.

Responsibilities

• Principal Investigator (PI): Ensures the ISF is maintained according to study requirements and regulatory standards.
• Clinical Research Coordinators: Organize and maintain the ISF and ensure all essential documents are up-to-date.
• Study Sponsors: Provide guidance and support for the maintenance of the ISF.

Procedure

• Organization and Contents of ISF:
  • Maintain the ISF according to the standard structure outlined in the study protocol and applicable regulations (e.g., ICH-GCP).
  • Include essential documents such as study protocols, informed consent forms, case report forms, and safety reports.
• Document Management:
  • Ensure all documents in the ISF are clearly labeled and organized in a logical order.
  • Keep documents up-to-date and promptly file any new or revised documents.
  • Use version control for revised documents to track changes and maintain document history.
• Access and Security:
  • Provide controlled access to the ISF to authorized personnel only.
  • Maintain the ISF in a secure location to prevent unauthorized access, loss, or damage.
• Audit and Inspection Readiness:
  • Regularly review the ISF for completeness and accuracy to ensure audit and inspection readiness.
  • Address any discrepancies or missing documents promptly.
• Record-Keeping:
  • Keep records of ISF maintenance activities, including reviews, updates, and document retrievals.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• ISF: Investigator Site File
• ICH-GCP: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice

Documents

• ISF structure and content list
• Document version control logs
• ISF review and audit logs

References

• ICH-GCP guidelines
• Institutional policies for ISF management

SOP Version

Version: 1.0