Standard Operating Procedure for Observing Post-Dose Adverse Events in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/064/2025
Supersedes	SOP/BA-BE/064/2022
Page No.	Page 1 of 10
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a systematic approach for monitoring, identifying, recording, and managing post-dose adverse events (AEs) in subjects participating in Bioavailability/Bioequivalence (BA/BE) studies, ensuring participant safety and regulatory compliance.

2. Scope

This SOP is applicable to all personnel involved in the observation and documentation of post-dose adverse events at the clinical phase of BA/BE studies.

3. Responsibilities

• Clinical Investigator: Reviews and assesses severity and causality of adverse events.
• Ward Nurses: Perform routine checks on vital signs and subject well-being, and report any AEs to the Investigator.
• Clinical Research Coordinator (CRC): Ensures proper documentation and reporting in Case Report Forms and AE Logs.

4. Accountability

The Principal Investigator is accountable for ensuring timely detection, management, and documentation of all post-dose adverse events in accordance with study protocol and GCP.

5. Procedure

5.1 Monitoring Period

1. Begin AE monitoring immediately after dosing and continue for at least 24 hours or as per protocol.
2. Subjects should remain under direct observation for the first 2–4 hours post-dose.

5.2 Observation Parameters

1. Vital signs: Monitor blood pressure, pulse rate, respiratory rate, and temperature at defined intervals.
2. Subjective Symptoms: Ask volunteers to report any symptoms such as nausea, dizziness, headache, abdominal pain, vomiting, etc.
3. Behavioral Observation: Note any changes in consciousness, agitation, or discomfort.

5.3 AE Detection and Grading

1. If an AE is reported or observed, document the following:
   • Onset time, duration, severity (mild/moderate/severe)
   • Relatedness to study drug (unrelated/possible/probable/definite)
2. Record in Annexure-1: Adverse Event Reporting Form.

5.4 Medical Management

1. Provide first aid or medical intervention based on the nature and severity of the event.
2. Refer the subject to the onsite physician or external facility if needed.
3. Document medical actions in Annexure-2: AE Management Log.

5.5 Follow-Up and Reporting

1. Follow up on the subject’s condition until resolution or stabilization of the AE.
2. Update AE form with resolution date and outcome.
3. Report all AEs in line with regulatory and protocol timelines (e.g., SAE to be reported within 24 hours).

5.6 Documentation

1. Enter AE data into CRF and AE master log.
2. Ensure signature and date of reporting personnel and investigator review.

6. Abbreviations

• AE: Adverse Event
• SAE: Serious Adverse Event
• BA: Bioavailability
• BE: Bioequivalence
• PI: Principal Investigator
• CRC: Clinical Research Coordinator

7. Documents

1. Adverse Event Reporting Form – Annexure-1
2. AE Management Log – Annexure-2
3. CRF AE Section

8. References

• ICH E2A – Clinical Safety Data Management
• ICH E6(R2) – Good Clinical Practice
• 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: Adverse Event Reporting Form

Subject ID	AE Description	Onset Time	Severity	Causality	Outcome
VOL-064	Nausea	07:45	Mild	Possible	Resolved

Annexure-2: AE Management Log

Date	Subject ID	Action Taken	Treated By	Remarks
17/04/2025	VOL-064	Antiemetic administered	Dr. Sunita Reddy	Recovered fully

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial release	Study requirement	QA Head
17/04/2025	2.0	Inclusion of structured forms and AE severity criteria	Inspection readiness	QA Head