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