Standard Operating Procedure for Managing Protocol Deviations During Clinical Phase of BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/088/2025
Supersedes	SOP/BA-BE/088/2022
Page No.	Page 1 of 9
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the standardized process for the identification, documentation, reporting, and resolution of protocol deviations occurring during the clinical phase of Bioavailability/Bioequivalence (BA/BE) studies, ensuring compliance with GCP and applicable regulations.

2. Scope

This SOP applies to all study personnel involved in the conduct, oversight, and monitoring of the clinical phase of BA/BE studies conducted at the clinical research facility.

3. Responsibilities

• Clinical Research Coordinator (CRC): Identifies and documents protocol deviations and informs the investigator immediately.
• Principal Investigator (PI): Assesses the deviation, determines its impact on subject safety and study data, and signs off on corrective actions.
• QA Officer: Reviews deviation logs, trends deviations, and ensures CAPA implementation.

4. Accountability

The Study Director is accountable for ensuring all protocol deviations are addressed promptly and documented in compliance with regulatory expectations.

5. Procedure

5.1 Definition of Protocol Deviation

1. A protocol deviation is any instance where the approved protocol, SOPs, or GCP requirements are not followed.
2. Deviations may be classified as:
   • Major: Affects subject safety or data integrity
   • Minor: Administrative or procedural, without major impact

5.2 Identification and Documentation

1. Any study team member identifying a deviation must immediately notify the CRC.
2. CRC documents the deviation in Annexure-1: Protocol Deviation Reporting Form.
3. Initial documentation must include:
   • Study code and subject ID
   • Date and time of deviation
   • Description of deviation
   • Immediate action taken

5.3 Deviation Assessment

1. PI reviews the deviation and evaluates:
   • Impact on subject safety
   • Impact on data quality
   • Whether the subject can continue in the study
2. QA reviews and provides oversight.

5.4 Corrective and Preventive Actions (CAPA)

1. PI and QA jointly define CAPA and document it in Annexure-2: CAPA Log.
2. Implement CAPA and monitor effectiveness.

5.5 Reporting to Ethics Committee and Sponsor

1. All major deviations must be reported to the sponsor and Ethics Committee as per defined timelines.
2. Retain copies of communication in the Trial Master File.

5.6 Deviation Tracking and Trending

1. QA compiles all deviations in Annexure-3: Deviation Log Summary.
2. Deviations are reviewed periodically to identify trends and process improvements.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• PI: Principal Investigator
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Protocol Deviation Reporting Form – Annexure-1
2. CAPA Log – Annexure-2
3. Deviation Log Summary – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules
• Study Protocol and Monitoring 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: Protocol Deviation Reporting Form

Study Code	Subject ID	Date	Deviation Description	Action Taken
BE/2025/006	VOL-088	17/04/2025	Dose delay by 30 mins	Documented, PI notified

Annexure-2: CAPA Log

Date	Deviation	CAPA Proposed	Implemented By	Effectiveness Checked
18/04/2025	Dose delay	Alarm set for next dose	CRC	QA Confirmed

Annexure-3: Deviation Log Summary

Month	Total Deviations	Major	Minor	Action Summary
April 2025	2	1	1	Training session scheduled

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial SOP	Process Documentation	QA Head
17/04/2025	2.0	Annexures added and CAPA workflow clarified	Audit Feedback	QA Head