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Standard Operating Procedure for IP Reconciliation and Accountability Logs

Purpose

The purpose of this SOP is to define procedures for reconciliation and accountability of investigational products (IP) throughout the lifecycle of a clinical trial. Accurate reconciliation ensures that all IP is tracked from receipt to dispensing, return, or destruction, thus protecting participant safety and ensuring compliance with regulatory guidelines.

Scope

This SOP applies to investigators, pharmacists, study coordinators, sponsors, and CROs involved in IP management. It covers the use of accountability logs, reconciliation at subject and site level, discrepancy management, and documentation in TMF and ISF.

Responsibilities

• Principal Investigator (PI): Responsible for overall accountability of IP at the trial site.
• Pharmacist/Authorized Designee: Maintains accountability logs, performs reconciliation, and reports discrepancies.
• Study Coordinator: Ensures logs are updated, signed, and filed in ISF and TMF.
• Sponsor/CRO: Reviews accountability logs during monitoring visits and trial close-out.
• Quality Assurance Officer: Audits reconciliation records during inspections.

Accountability

The PI is accountable for ensuring that IP reconciliation is performed accurately, timely, and documented appropriately. Sponsors are accountable for verifying reconciliation across all trial sites.

Procedure

1. Receipt and Documentation
Record receipt of IP in the IP Receipt Log.
Verify quantity, lot number, and expiry date against shipment documents.

2. Dispensing Accountability
Record subject ID, quantity dispensed, and batch number in Dispensing Log.
Ensure signatures of dispensing staff and investigator.

3. Returns and Destruction
Record returned and destroyed IP quantities in Accountability Log.
Attach destruction certificate where applicable.

4. Periodic Reconciliation
Perform monthly reconciliation of stock against logs.
Investigate and document discrepancies.
Report unresolved discrepancies to sponsor.

5. Final Reconciliation
Conduct close-out reconciliation with sponsor/CRO.
Ensure final accountability log is signed by PI and filed in ISF and TMF.

6. Archiving
Archive accountability logs for minimum 5 years post-trial or as per national regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• IP: Investigational Product
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. IP Accountability Log (Annexure-1)
2. Periodic Reconciliation Report (Annexure-2)
3. Final Reconciliation Certificate (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Clinical Trial Drug Accountability
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Guidelines on Pharmaceutical Accountability

Version: 1.0

Approval Section

Annexures

Annexure-1: IP Accountability Log

Annexure-2: Periodic Reconciliation Report

Annexure-3: Final Reconciliation Certificate

Revision History

For more SOPs visit: Pharma SOP