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“headline”: “SOP for Investigational Product Management and Accountability”,
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“description”: “Detailed SOP describing sponsor, investigator, pharmacist, and CRO responsibilities for investigational product management and accountability in New Zealand clinical trials, aligned with Medsafe, HDEC, and ICH GCP requirements.”,
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“datePublished”: “2025-08-28”,
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Investigational Product Management and Accountability SOP

Purpose

The purpose of this SOP is to outline procedures for investigational product (IP) management and accountability in clinical trials conducted in New Zealand. It ensures compliance with Medsafe, Health and Disability Ethics Committees (HDEC), and ICH GCP requirements for receipt, labeling, storage, dispensing, reconciliation, and destruction of IP.

Scope

This SOP applies to all clinical trials using investigational medicinal products in New Zealand. It covers sponsor, investigator, and pharmacist responsibilities for IP lifecycle management, including handling, accountability, record-keeping, and audits.

Responsibilities

• Sponsor: Ensures appropriate labeling, packaging, distribution, and reconciliation of IP; provides training to site staff.
• Principal Investigator (PI): Maintains oversight of IP at the site, ensures accountability logs are complete, and delegates dispensing to qualified pharmacists.
• Pharmacist: Manages receipt, storage, dispensing, reconciliation, and destruction of IP in accordance with trial protocol and GCP.
• CRO: Provides oversight and support for IP management on behalf of the sponsor when delegated.
• Quality Assurance (QA): Conducts audits of IP accountability records and ensures CAPA implementation.

Accountability

The sponsor is accountable for ensuring compliance with all IP management requirements. The PI is accountable for site-level IP management and reconciliation. The pharmacist is accountable for daily operations and documentation.

Procedure

1. Receipt of IP

1. Verify shipment against shipping documents.
2. Document receipt in IP Accountability Log (Annexure-1).
3. Report discrepancies to sponsor immediately.

2. Storage of IP

1. Store IP under conditions defined in protocol and product labeling (e.g., temperature, humidity).
2. Maintain temperature logs and calibrate storage equipment regularly.
3. Restrict access to authorized personnel.

3. Dispensing of IP

1. Dispense IP only to eligible participants after consent and randomization.
2. Document dispensing in IP Dispensing Log (Annexure-2).
3. Ensure blinding procedures are maintained.

4. Accountability and Reconciliation

1. Record all receipts, dispensing, returns, and destruction of IP.
2. Reconcile IP inventory monthly and at trial close-out.

5. Return and Destruction

1. Return unused IP to sponsor or authorized destruction vendor.
2. Document destruction in IP Destruction Log (Annexure-3).

6. Documentation and Archiving

1. Maintain IP logs in ISF and TMF.
2. Archive IP documentation for at least 10 years post-trial.

Abbreviations

• IP: Investigational Product
• PI: Principal Investigator
• QA: Quality Assurance
• CRO: Contract Research Organization
• HDEC: Health and Disability Ethics Committees
• ISF: Investigator Site File
• TMF: Trial Master File
• CAPA: Corrective and Preventive Action
• GCP: Good Clinical Practice
• Medsafe: Medicines and Medical Devices Safety Authority

Documents

1. IP Accountability Log (Annexure-1)
2. IP Dispensing Log (Annexure-2)
3. IP Destruction Log (Annexure-3)

References

• Medsafe — Medicines and Medical Devices Safety Authority
• HDEC — Health and Disability Ethics Committees
• ICH E6(R2) Good Clinical Practice
• WHO Clinical Trial Standards

Version: 1.0

Approval

Annexures

Annexure-1: IP Accountability Log

Annexure-2: IP Dispensing Log

Annexure-3: IP Destruction Log

Revision History

For more SOPs visit: Pharma SOP.