Protocol for Handling Returned and Expired Drugs in BA/BE Studies
Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the procedures for the proper handling, documentation, and disposal of returned, expired, or unused investigational drugs used in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.
Scope
This SOP applies to all study personnel involved in the receipt, storage, distribution, and disposal of investigational drugs, including Investigators, Study Coordinators, Pharmacists, and Clinical Research Associates (CRAs).
Responsibilities
- The Investigator is responsible for ensuring the safe storage, handling, and disposal of investigational drugs in accordance with study protocols, regulatory requirements, and sponsor agreements.
- The Study Coordinator is responsible for coordinating the return and destruction of investigational drugs, documenting drug disposition, and maintaining drug accountability records.
- The Pharmacist is responsible for verifying the accuracy of drug returns, ensuring proper storage conditions, and overseeing drug destruction activities in compliance with pharmacy regulations.
- The Clinical Research Associate (CRA) is responsible for monitoring drug accountability, documenting drug returns and destruction, and verifying compliance with study protocols and regulatory requirements.
Procedure
- Receive returned investigational drugs from study participants, study sites, or other authorized personnel according to established procedures and timelines.
- Verify the accuracy and integrity of returned drug supplies, including batch numbers, expiry dates, and
Abbreviations
- SOP – Standard Operating Procedure
- BA – Bioavailability
- BE – Bioequivalence
- CRA – Clinical Research Associate
- IRB – Institutional Review Board
Documents
- Drug Accountability Log
- Drug Return Documentation
- Drug Destruction Records
- Communication Log
Reference
International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for handling investigational drugs in clinical research.
SOP Version
Version 1.0