and verification of study drugs for bioavailability/bioequivalence (BA/BE) studies conducted at clinical research facilities.

3. Responsibilities

• Pharmacist: Dispenses the correct study drug as per randomization code and verifies dosing unit, expiry, and labeling.
• Study Coordinator: Cross-verifies and documents the dispensing records and maintains accountability logs.
• QA Officer: Reviews dispensing and verification records for audit readiness.

4. Accountability

The Clinical Trial Pharmacist is accountable for ensuring that study drug dispensing is accurate, documented, and traceable, with no deviation from the study protocol or blinding integrity.

5. Procedure

5.1 Preparation for Dispensing

1. Verify receipt and storage of IPs and reference products as per SOP/BA-BE/132/2025.
2. Ensure that temperature logs and expiry dates are reviewed before dispensing.
3. Check that the clinical site has received the randomization schedule and drug code sheet from the sponsor or data manager.

5.2 Dispensing Process

1. Identify subject ID and randomization code prior to dispensing.
2. Match the assigned product with the appropriate randomization code and study period.
3. Confirm:
   • Product identity (Test or Reference)
   • Correct strength and dosage form
   • Labeling as per regulatory guidelines
4. Dispense in pre-labeled units under clean conditions and document using Annexure-1: Drug Dispensing Log.

5.3 Double Verification and Documentation

1. Second individual (clinical coordinator or trained study nurse) must perform independent verification.
2. Both individuals must sign Annexure-2: Dispensing Verification Form indicating correctness of product, quantity, and subject assignment.
3. Enter details into IMP Accountability Log (linked to SOP/BA-BE/81/2025).

5.4 Blinding Considerations

1. For blinded studies:
   • Ensure products are visually indistinguishable.
   • Maintain blinding records separately and restrict access to unblinded staff.
2. Use Annexure-3: Blinding Verification Checklist to document safeguards.

5.5 Post-Dispensing Reconciliation

1. Reconcile dispensed, returned, and remaining doses after each study period.
2. Document in Annexure-4: Post-Dispensing Reconciliation Sheet.
3. Report any discrepancies to QA and document a deviation report if necessary.

5.6 Storage and Record Retention

1. All logs and forms must be filed in the Trial Master File (TMF) and retained for at least 5 years.
2. Ensure secure storage of documentation and restricted access.

6. Abbreviations

• IP: Investigational Product
• IMP: Investigational Medicinal Product
• QA: Quality Assurance
• TMF: Trial Master File

7. Documents

1. Drug Dispensing Log – Annexure-1
2. Dispensing Verification Form – Annexure-2
3. Blinding Verification Checklist – Annexure-3
4. Post-Dispensing Reconciliation Sheet – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• 21 CFR Part 312 – Investigational New Drug Application

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Drug Dispensing Log

Date	Subject ID	Period	Product	Batch No.	Dispensed By
17/04/2025	SUB102	P1	Test	B23T01	Rajesh Kumar

Annexure-2: Dispensing Verification Form

Subject ID	Verified Product	Verified By	Date	Remarks
SUB102	Test	Sunita Reddy	17/04/2025	OK

Annexure-3: Blinding Verification Checklist

Check	Criteria	Result	Initials
Visual similarity	Test vs Ref indistinguishable	Pass	SR

Annexure-4: Post-Dispensing Reconciliation Sheet

Batch	Dispensed	Returned	Remaining	Reconciled By
B23T01	24	2	0	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	Regulatory compliance	QA Head
17/04/2025	2.0	Added blinding checklist and reconciliation forms	Audit feedback	QA Head