Standard Operating Procedure for Periodic Clinical Safety Assessments in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/066/2025
Supersedes	SOP/BA-BE/066/2022
Page No.	Page 1 of 10
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a standard operating procedure for conducting periodic clinical safety assessments during Bioavailability/Bioequivalence (BA/BE) studies to ensure continuous monitoring of subject safety throughout the clinical trial.

2. Scope

This SOP applies to all study personnel involved in performing, recording, and evaluating clinical safety assessments of volunteers during BA/BE studies, including baseline, on-study, and follow-up assessments.

3. Responsibilities

• Principal Investigator (PI): Oversees safety evaluations and reviews findings.
• Sub-Investigator: Conducts clinical assessments and initiates follow-up for abnormal findings.
• Clinical Research Coordinator (CRC): Ensures timely scheduling and documentation of all safety assessments.
• Nursing Staff: Assists in sample collection, vitals, and ECG procedures.

4. Accountability

The Principal Investigator is accountable for ensuring the clinical safety of all subjects through timely assessments and documentation as per the approved protocol and regulatory requirements.

5. Procedure

5.1 Baseline Safety Assessment

1. Conduct at screening or prior to first dose:
   • Complete physical examination
   • Vital signs
   • 12-lead ECG
   • Laboratory tests (hematology, biochemistry, urinalysis, serology)
2. Document results in Annexure-1: Baseline Safety Assessment Form.

5.2 On-Study Periodic Safety Assessments

1. Perform interim safety evaluations at predefined intervals post-dose as per protocol:
   • Vitals (e.g., every 2-4 hours post-dose)
   • Adverse Event (AE) review
   • Physical exams (if required)
2. Record in Annexure-2: Periodic Safety Monitoring Log.

5.3 Laboratory Monitoring

1. Repeat safety labs at follow-up or as per protocol.
2. Compare with baseline to detect any clinically significant change.
3. Document in Annexure-3: Laboratory Safety Follow-Up Summary.

5.4 ECG Monitoring

1. Repeat ECGs at required time points (e.g., baseline, post-dose 4h, discharge).
2. Interpret by qualified physician and documented in Annexure-4: ECG Monitoring Record.

5.5 Handling Abnormal Findings

1. Abnormal lab/ECG/vitals are to be reviewed by the Investigator for:
   • Clinical significance
   • Eligibility continuation
   • Medical management
2. All findings and actions to be documented in Annexure-5: Abnormal Findings Action Log.

5.6 Safety Assessment at Follow-Up

1. Conduct follow-up safety checks at study exit or as defined by protocol.
2. Ensure all AEs are resolved or under medical care.
3. Document in Annexure-6: Final Safety Assessment Form.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• AE: Adverse Event
• ECG: Electrocardiogram
• PI: Principal Investigator

7. Documents

1. Baseline Safety Assessment Form – Annexure-1
2. Periodic Safety Monitoring Log – Annexure-2
3. Laboratory Safety Follow-Up Summary – Annexure-3
4. ECG Monitoring Record – Annexure-4
5. Abnormal Findings Action Log – Annexure-5
6. Final Safety Assessment Form – Annexure-6

8. References

• ICH E6(R2) – Good Clinical Practice
• ICH E2A – Clinical Safety Data Management
• Study-Specific Protocol

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Baseline Safety Assessment Form

Subject ID	Vitals	ECG	Physical Exam	Labs	Date
VOL-066	Normal	Normal	Unremarkable	Within range	15/04/2025

Annexure-2: Periodic Safety Monitoring Log

Subject ID	Timepoint	Vitals	AE Noted	Initials
VOL-066	2h Post-Dose	Normal	No	R. Pawar

Annexure-3: Laboratory Safety Follow-Up Summary

Subject ID	Date	Parameters Abnormal	Action Taken
VOL-066	20/04/2025	None	Not Applicable

Annexure-4: ECG Monitoring Record

Subject ID	Date	Time	ECG Result	Reviewed By
VOL-066	17/04/2025	08:00	Normal Sinus Rhythm	Dr. Sunita Reddy

Annexure-5: Abnormal Findings Action Log

Subject ID	Assessment Type	Finding	PI Action	Date
VOL-066X	ECG	Tachycardia	Dosing Deferred	17/04/2025

Annexure-6: Final Safety Assessment Form

Subject ID	Exit Vitals	Physical Exam	AEs Resolved	Follow-Up Needed
VOL-066	Stable	Unremarkable	Yes	No

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
13/01/2022	1.0	Initial version	Protocol Implementation	QA Head
17/04/2025	2.0	Added structured annexures and expanded lab tracking	Audit Recommendation	QA Head