Standard Operating Procedure for Management of Regulatory Documentation

Purpose

This SOP outlines the procedures for maintaining regulatory documents in clinical trials and clinical studies. The goal is to ensure accurate, organized, and secure maintenance of regulatory documentation to support compliance with applicable regulations and study-specific requirements.

Scope

This SOP applies to all personnel involved in the creation, management, and maintenance of regulatory documents for clinical trials and clinical studies, including principal investigators, clinical research coordinators, regulatory affairs teams, and data management teams.

Responsibilities

• Principal Investigator (PI): Oversees the maintenance of regulatory documents and ensures compliance with regulatory and study-specific requirements.
• Regulatory Affairs Team: Manages regulatory documentation processes, including creation, review, approval, and archiving of documents.
• Clinical Research Coordinators: Assist with maintaining regulatory documents, including obtaining and filing required approvals and reports.
• Data Management Team: Ensures the integrity and security of electronic regulatory documents.

Procedure

• Creation and Review of Regulatory Documents:
  • Develop regulatory documents according to study protocols and regulatory requirements.
  • Review and approve regulatory documents, including informed consent forms and study protocols.
• Maintenance and Storage of Regulatory Documents:
  • Organize and maintain regulatory documents in a secure and accessible location.
  • Ensure documents are properly labeled and categorized for easy retrieval.
  • Maintain an inventory of regulatory documents and track document versions.
• Updates and Revisions:
  • Review and update regulatory documents as necessary to reflect changes in study protocols or regulations.
  • Document and track changes to regulatory documents, including approvals and revision history.
• Archiving and Retention:
  • Archive regulatory documents according to institutional and regulatory requirements.
  • Maintain records of archived documents and ensure they are stored securely for the required retention period.
• Compliance and Auditing:
  • Conduct regular audits of regulatory documents to ensure compliance with applicable regulations and study protocols.
  • Document any findings and take corrective actions as needed.
• Training and Education:
  • Provide training to study personnel on regulatory document maintenance and best practices.
  • Offer ongoing education to ensure adherence to regulatory documentation procedures.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Regulatory document inventory and tracking logs
• Version-controlled copies of regulatory documents
• Regulatory document revision histories
• Archive logs and retention schedules
• Audit reports and corrective action plans

References

• Institutional policies for regulatory document maintenance
• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Study protocols and investigator brochures

SOP Version

Version: 1.0