Protocol for Document Archiving in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the systematic archiving and retention of study documents generated during Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the conduct and oversight of BA/BE studies, including Study Coordinators, Data Managers, Clinical Research Associates (CRAs), and Quality Assurance personnel.

Responsibilities

• The Study Coordinator is responsible for identifying study documents requiring archiving, organizing documents for archiving, and maintaining the archive inventory.
• The Data Manager is responsible for managing electronic study documents, ensuring proper storage and backup procedures, and facilitating access to archived data.
• The Clinical Research Associate (CRA) is responsible for verifying the completeness and accuracy of study documents before archiving and ensuring compliance with archiving procedures.
• The Quality Assurance (QA) personnel are responsible for conducting periodic audits of the study archive, ensuring compliance with archiving procedures and regulatory requirements.

Procedure

1. Identify study documents requiring archiving based on regulatory requirements, study protocols, and sponsor guidelines.
2. Organize study documents for archiving in a systematic manner, including paper documents, electronic files, and laboratory records.
3. Label and index archived documents clearly, including study name, date, document type, and retention period, to facilitate retrieval and tracking.
4. Store archived documents in a secure and controlled environment, protected from environmental hazards such as fire, water damage, and unauthorized access.
5. Implement electronic archiving systems for managing electronic study documents, including version control, access restrictions, and audit trails.
6. Establish retention periods for study documents based on regulatory requirements and study protocols, and ensure that documents are retained for the required duration.
7. Regularly review archived documents to identify documents eligible for destruction or transfer to long-term storage, according to established retention schedules.
8. Document all archiving activities, including document inventory, storage locations, access logs, and disposal records, in accordance with regulatory requirements.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• QA – Quality Assurance

Documents

• Archive Inventory
• Archiving Log
• Document Retention Schedule
• Access Control Policy

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory requirements for document archiving and retention in clinical research.

SOP Version

Version 1.0