Standard Operating Procedure for Placebo and Comparator Product Management

Purpose

This SOP outlines the procedures for the use of placebos and comparator products in clinical trials and clinical studies. The goal is to ensure that placebos and comparator products are used appropriately, safely, and in compliance with regulatory requirements and study protocols.

Scope

This SOP applies to all personnel involved in the management of placebos and comparator products in clinical trials and clinical studies, including principal investigators, clinical research coordinators, study sponsors, and pharmacy personnel.

Responsibilities

• Principal Investigator (PI): Oversees the use of placebos and comparator products in the study and ensures compliance with protocols and regulations.
• Clinical Research Coordinators: Assist with the coordination and management of placebos and comparator products in the study.
• Study Sponsors: Provide support and guidance for the appropriate use of placebos and comparator products.
• Pharmacy Personnel: Manage the storage, dispensing, and handling of placebos and comparator products.

Procedure

• Selection of Placebos and Comparator Products:
  • Select placebos and comparator products that are consistent with study objectives and regulatory requirements.
  • Ensure placebos and comparator products are identical in appearance and administration to maintain blinding in the study.
• Procurement and Storage:
  • Procure placebos and comparator products from approved sources.
  • Store placebos and comparator products in controlled, secure environments according to the manufacturer’s instructions and regulatory guidelines.
• Dispensing and Administration:
  • Dispense placebos and comparator products according to study protocols and participant needs.
  • Maintain accurate records of dispensing and administration, including participant IDs, dates, and dosages.
• Monitoring and Accountability:
  • Monitor the use of placebos and comparator products throughout the study to ensure compliance with protocols and regulations.
  • Maintain an inventory of placebos and comparator products, including tracking usage and expiration dates.
• Reporting and Record-Keeping:
  • Report any issues related to placebos or comparator products, including adverse events or supply shortages, to the study team and relevant regulatory authorities.
  • Maintain records of placebos and comparator products, including procurement, storage, dispensing, and administration.

Abbreviations Used

• SOP: Standard Operating Procedure
• PI: Principal Investigator

Documents

• Inventory records of placebos and comparator products
• Records of dispensing and administration
• Correspondence with regulatory authorities (if applicable)

References

• Regulatory guidelines for the use of placebos and comparator products in clinical trials
• Institutional policies for the management of placebos and comparator products

SOP Version

Version: 1.0