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Standard Operating Procedure for IP Dispensing and Administration

Purpose

The purpose of this SOP is to establish standardized procedures for dispensing and administering investigational products (IP) to trial participants. It ensures that IP is dispensed accurately, administered safely, and recorded appropriately in compliance with Good Clinical Practice (GCP) and regulatory standards.

Scope

This SOP applies to all investigators, pharmacists, study coordinators, nurses, and site staff involved in IP dispensing and administration during clinical trials. It includes processes for blinded and open-label trials, oral and injectable products, and device-based interventions.

Responsibilities

• Principal Investigator (PI): Responsible for oversight of IP dispensing and administration.
• Pharmacist/Authorized Designee: Dispenses IP as per prescription and protocol.
• Study Nurse/Investigator: Administers IP to participants according to protocol requirements.
• Study Coordinator: Ensures records of dispensing and administration are complete and filed.
• Sponsor/CRO: Provides oversight and reviews dispensing documentation during monitoring visits.
• Quality Assurance Officer: Verifies dispensing and administration compliance during audits.

Accountability

The PI is accountable for ensuring investigational products are dispensed and administered according to approved protocol, regulatory requirements, and ethical guidelines. Sponsors are accountable for oversight of dispensing practices across sites.

Procedure

1. Prescription and Authorization
IP must be dispensed only upon written prescription by the PI or authorized sub-investigator.
Verify prescription against protocol requirements and subject eligibility.

2. Dispensing Process
Pharmacist verifies batch number, expiry date, and dosage prior to dispensing.
Record details in the IP Dispensing Log (Annexure-1).
Ensure correct subject ID is matched with dispensed IP.

3. Administration of IP
Trained study staff administer IP as per protocol (oral, injectable, topical, or device-specific).
Document administration details in the IP Administration Record (Annexure-2).

4. Blinded and Randomized Trials
Maintain blinding during dispensing.
Ensure double-checking by two staff members for randomized assignments.

5. Accountability and Documentation
Maintain accurate logs of dispensed, administered, and returned IP.
Record discrepancies and notify sponsor immediately.
File dispensing records in ISF and TMF.

6. Subject Safety and Adherence
Educate participants on administration instructions and adherence importance.
Record compliance checks during follow-up visits.

7. Archiving
Archive dispensing and administration records for a minimum of 5 years post-trial or as per 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 Dispensing Log (Annexure-1)
2. IP Administration Record (Annexure-2)
3. IP Accountability Log (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Clinical Trial Guidance
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Guidelines on Investigational Product Use

Version: 1.0

Approval Section

Annexures

Annexure-1: IP Dispensing Log

Annexure-2: IP Administration Record

Annexure-3: IP Accountability Log

Revision History

For more SOPs visit: Pharma SOP