Standard Operating Procedure (SOP) for Handling and Archiving of Study Documents

Download the free Template

Introduction:
Protect the integrity, traceability, and regulatory compliance of your clinical and non-clinical research records with our Standard Operating Procedure (SOP) for Handling and Archiving of Study Documents. This SOP is designed for organizations operating in highly regulated environments such as pharmaceuticals, biotechnology, and medical devices, ensuring that all essential study documents are managed, stored, and archived in a controlled and compliant manner.

Overview:
The SOP for Handling and Archiving of Study Documents establishes a robust, standardized process for the lifecycle management of study-related documents—from initial creation through secure long-term archiving. This SOP aligns with ICH GCP, FDA 21 CFR Part 11, and other applicable regulatory standards, enabling organizations to ensure documentation is accurate, accessible, and protected from unauthorized access or loss.

Key Sections Included in the SOP:

1. Purpose:
   Defines the objective of ensuring the secure handling, retention, and archival of essential study documents to support data integrity, regulatory inspections, and study reconstruction.
2. Scope:
   Applies to all physical and electronic study documents generated during the planning, conduct, and reporting phases of clinical, preclinical, and laboratory-based studies.
3. Responsibilities:
   Assigns clear accountability to study sponsors, investigators, document custodians, records managers, and quality personnel involved in document handling and archiving.
4. Document Types Covered:
   • Lists essential study documents such as protocols, investigator brochures, case report forms (CRFs), informed consent forms, monitoring visit reports, and regulatory submissions.
   • Includes both original and certified electronic copies.
5. Document Handling Procedures:
   • Details requirements for naming conventions, version control, indexing, and filing of documents.
   • Establishes controls for document updates, access restrictions, and secure transfers between systems or locations.
6. Electronic Document Management Systems (EDMS):
   • Provides criteria for systems used to manage electronic documents, including validation status, audit trails, backup, and user access control.
   • Addresses compliance with 21 CFR Part 11 for electronic records and signatures.
7. Archiving Requirements:
   • Describes the timeline and conditions for transitioning documents from active use to archival status.
   • Establishes minimum retention periods based on study type, region, and regulatory expectations.
8. Storage Conditions:
   • Specifies environmental and physical requirements for archival facilities, including temperature, humidity, fire protection, and restricted access.
   • Ensures protection against deterioration, loss, or unauthorized modification.
9. Access and Retrieval:
   • Outlines processes for authorized access, review, and retrieval of archived documents.
   • Includes request tracking and documentation of access events.
10. Disaster Recovery and Backup:

• Provides protocols for ensuring document preservation in the event of system failure, natural disaster, or other emergencies.
• Mandates regular data backups for electronic records and secure off-site storage when necessary.

1. Destruction of Documents:

• Specifies conditions under which documents may be destroyed after retention periods are met.
• Requires documented approvals, secure destruction methods, and certificates of destruction.

1. Audit and Inspection Readiness:

• Ensures records are maintained in a state of readiness for regulatory inspections and sponsor audits.

1. Training and Competency:

• Requires staff involved in document handling and archiving to be trained in applicable SOPs, regulatory standards, and data integrity principles.

Why Download This SOP?

• Achieve Regulatory Compliance: Aligns with ICH GCP, FDA, EMA, and ISO requirements for document management.
• Preserve Study Integrity: Ensures secure and traceable documentation throughout the study lifecycle.
• Improve Inspection Readiness: Provides a fully documented, compliant archiving system for regulatory reviews.
• Support Data Integrity and Transparency: Maintains records in a controlled and accessible format.
• Reduce Operational Risk: Protects against loss of critical documents due to mishandling or inadequate storage.

Support and Contact Information:
For questions or additional guidance on handling and archiving study documents, please reach out to our support team. We’re here to help you meet the highest standards of documentation management and regulatory compliance.