facility.

3. Responsibilities

• Pharmacist: Maintains blinding by preparing and dispensing coded IPs and ensuring that treatment identity is not disclosed.
• Clinical Research Coordinator (CRC): Records IP administration without revealing identity and reports any suspected unblinding incident.
• Principal Investigator (PI): Ensures clinical staff are unaware of treatment allocation and oversees blinding protocol adherence.
• QA Officer: Audits processes and documents for any breach in blinding and ensures preventive actions are in place.

4. Accountability

The PI and Study Director are accountable for the maintenance of blinding and for ensuring all staff follow procedures that prevent unintentional or intentional unblinding during the study.

5. Procedure

5.1 Preparation and Labeling of IPs

1. Pharmacist receives treatment allocation codes and packaging instructions from sponsor or randomization master list.
2. Label each treatment as per Annexure-1: Blind Label Template, with:
   • Study code
   • Subject ID
   • Dose number
   • “For Clinical Trial Use Only”
3. Do not mention product name or identity on the label.

5.2 Dispensing and Administration

1. Only unblinded pharmacist or designee dispenses the IP as per the randomization code.
2. Administer IP to the subject by trained nursing staff not involved in randomization or aware of product identity.
3. CRC records time and dosing details in Annexure-2: IP Administration Log, maintaining the blind.

5.3 Emergency Unblinding

1. Emergency unblinding is permitted only if subject safety requires knowledge of the administered treatment.
2. Unblinding may only be authorized by the PI and must be documented in Annexure-3: Unblinding Authorization Form.
3. Inform sponsor and ethics committee immediately after the unblinding event.

5.4 Monitoring and Deviation Handling

1. All staff must report any suspected or actual breach of blinding to QA and the PI.
2. Document incidents in Annexure-4: Blinding Deviation Log.
3. Conduct Root Cause Analysis (RCA) and implement corrective and preventive actions.

5.5 Training and Documentation

1. Train all involved staff on blinding procedures prior to study start.
2. Maintain training records as part of the trial master file (TMF).

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• PI: Principal Investigator
• IP: Investigational Product
• QA: Quality Assurance
• RCA: Root Cause Analysis

7. Documents

1. Blind Label Template – Annexure-1
2. IP Administration Log – Annexure-2
3. Unblinding Authorization Form – Annexure-3
4. Blinding Deviation Log – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• Indian GCP Guidelines
• Study Protocol and Blinding Plan

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Blind Label Template

Study Code	Subject ID	Dose Number	Storage Condition	Labelled By
BE2025-098	VOL-098	Dose 1	2–8°C	Ravi Nair

Annexure-2: IP Administration Log

Subject ID	Dose Time	Form Administered	Given By	Remarks
VOL-098	08:00 AM	Tablet	Sunita Reddy	None

Annexure-3: Unblinding Authorization Form

Date	Subject ID	Reason	Authorized By	Outcome
17/04/2025	VOL-098	Medical emergency	Dr. A. Shah	Treatment revealed

Annexure-4: Blinding Deviation Log

Date	Subject ID	Description of Deviation	Corrective Action	Notified To
17/04/2025	VOL-098	IP identity disclosed by error	Re-training	QA & Sponsor

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial Release	New Study Setup	QA Head
17/04/2025	2.0	Added unblinding form and deviation log	GCP Compliance	QA Head