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Standard Operating Procedure for Controlled Substances Management in Clinical Trials

Purpose

The purpose of this SOP is to establish detailed procedures for handling controlled substances in clinical trials. Controlled drugs, including narcotics and psychotropic substances, require stringent oversight to ensure subject safety, prevent diversion, and maintain compliance with national and international regulations.

Scope

This SOP applies to all personnel involved in clinical trials using controlled substances, including investigators, pharmacists, site staff, and CROs. It covers licensing, receipt, storage, dispensing, accountability, destruction, and documentation of controlled substances in compliance with regulatory requirements.

Responsibilities

• Principal Investigator (PI): Accountable for compliance with all legal and regulatory requirements regarding controlled substances at the site.
• Pharmacist/Authorized Designee: Responsible for receipt, storage, dispensing, and maintaining controlled substances accountability logs.
• Study Coordinator: Ensures documentation and filing of controlled substance records in ISF and TMF.
• Sponsor/CRO: Provides oversight and verifies compliance during monitoring visits.
• Quality Assurance Officer: Reviews controlled drug handling records during audits and inspections.

Accountability

The PI is ultimately accountable for ensuring controlled substances are managed securely and in compliance with GCP and regulatory guidelines. Sponsors are accountable for monitoring and ensuring compliance at all sites.

Procedure

1. Licensing and Approvals
Obtain required licenses and permits for handling controlled substances from regulatory authorities.
File copies of licenses in ISF and TMF.

2. Receipt of Controlled Substances
Receive shipments only by authorized personnel.
Verify quantity, lot number, and integrity of packaging against shipping documents.
Record details in Controlled Substances Receipt Log (Annexure-1).

3. Storage
Store controlled substances in double-locked cabinets with restricted access.
Maintain continuous environmental and security monitoring.
Limit access to designated, trained staff only.

4. Dispensing
Dispense only upon prescription by PI or authorized sub-investigator.
Record dispensing in Controlled Substances Dispensing Log (Annexure-2).
Reconcile dispensed amounts with subject IDs and treatment arms.

5. Accountability and Reconciliation
Perform daily reconciliation of controlled substances stock.
Investigate and document discrepancies immediately.
Report unresolved discrepancies to regulatory authorities and sponsor.

6. Destruction
Destruction must be pre-approved by sponsor and regulatory body.
Conduct destruction in presence of authorized witness.
Document details in Certificate of Destruction (Annexure-3).

7. Documentation and Archiving
Maintain receipt, storage, dispensing, and destruction records in ISF and TMF.
Archive records for a minimum of 5 years post-trial or as per national requirements.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance
• DEA: Drug Enforcement Administration

Documents

1. Controlled Substances Receipt Log (Annexure-1)
2. Controlled Substances Dispensing Log (Annexure-2)
3. Certificate of Destruction (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Controlled Substances in Clinical Research
• EMA Clinical Trial Regulation
• CDSCO – Narcotic Drugs and Psychotropic Substances Guidelines
• WHO – Guidelines for Controlled Substances

Version: 1.0

Approval Section

Annexures

Annexure-1: Controlled Substances Receipt Log

Annexure-2: Controlled Substances Dispensing Log

Annexure-3: Certificate of Destruction

Revision History

For more SOPs visit: Pharma SOP