Standard Operating Procedure for Managing Study Medication in Clinical Research

Purpose

This SOP outlines the procedures for managing study medication in clinical trials and clinical studies. The goal is to ensure the safe, accurate, and compliant handling of study medication throughout the study.

Scope

This SOP applies to all personnel involved in the management of study medication, including principal investigators, clinical research coordinators, pharmacists, and other study team members.

Responsibilities

• Principal Investigator (PI): Provides oversight and ensures study medication management follows the study protocol and regulatory requirements.
• Pharmacist: Oversees the receipt, storage, preparation, and dispensing of study medication.
• Clinical Research Coordinators: Coordinate study medication handling and support participant education and compliance.

Procedure

• Receipt of Study Medication:
  • Verify the shipment and contents against the order documentation.
  • Inspect study medication for damage or tampering upon receipt.
  • Document the receipt, including quantities and batch/lot numbers.
• Storage and Inventory Management:
  • Store study medication according to protocol requirements (e.g., temperature, humidity).
  • Maintain an inventory of study medication, tracking usage and remaining quantities.
  • Conduct regular inventory checks and reconcile any discrepancies.
• Preparation and Dispensing:
  • Prepare and dispense study medication to participants according to the protocol.
  • Provide participants with clear instructions on how to take study medication.
  • Document dispensing activities, including participant IDs and dosage details.
• Medication Accountability:
  • Track medication usage, returns, and wastage.
  • Ensure medication accountability records are accurate and up-to-date.
• Participant Education and Compliance:
  • Educate participants on the correct use and storage of study medication.
  • Monitor participant compliance with the study medication regimen.
• Return and Disposal of Medication:
  • Return unused study medication to the sponsor or manufacturer as required.
  • Dispose of study medication in compliance with local regulations and study protocol.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRF: Case Report Form
• ICH-GCP: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice

Documents

• Study medication logs (e.g., inventory, dispensing)
• Medication order and receipt documentation
• Participant education materials
• Return and disposal records

References

• Regulatory guidelines (e.g., FDA, EMA, ICH-GCP)
• Institutional policies and procedures
• Local regulations for medication handling and disposal

SOP Version

Version: 1.0