Standard Operating Procedure for Archiving and Long-Term Record Storage

Purpose

This SOP outlines the procedures for archiving and long-term storage of records in clinical trials and clinical studies. The goal is to ensure the secure, organized, and accessible storage of essential documents and records for the duration required by regulatory authorities and institutional policies.

Scope

This SOP applies to all personnel involved in the archiving and long-term storage of records for clinical trials and clinical studies, including principal investigators, clinical research coordinators, study sponsors, and archiving specialists.

Responsibilities

• Principal Investigator (PI): Oversees and ensures proper archiving and long-term storage of study records according to protocols and regulations.
• Archiving Specialists: Manage the archiving and storage processes and maintain records of archived documents.
• Study Sponsors: Provide guidance and resources for proper archiving and storage of records.

Procedure

• Preparation for Archiving:
  • Identify records eligible for archiving based on study completion or other criteria outlined in the study protocol.
  • Organize and label records clearly for efficient archiving and retrieval.
• Archiving Process:
  • Store records in a secure and controlled environment, ensuring protection from damage, loss, or unauthorized access.
  • Use appropriate storage media (physical or electronic) for the type of records being archived.
• Inventory Management:
  • Maintain an inventory of archived records, including details such as record type, date of archiving, and location.
• Access and Retrieval:
  • Provide controlled access to archived records only to authorized personnel.
  • Ensure efficient retrieval processes for archived records when required.
• Retention Period:
  • Adhere to regulatory requirements and institutional policies for the retention period of different types of records.
• Disposal of Records:
  • Dispose of records in compliance with regulatory and institutional requirements after the retention period ends.
  • Document the disposal process and maintain records of disposed documents.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Inventory records of archived documents
• Records of disposed documents
• Access and retrieval logs

References

• Regulatory guidelines for archiving and long-term storage of records
• Institutional policies for archiving and record storage

SOP Version

Version: 1.0