Standard Operating Procedure for Clinical Documentation of Adverse Events in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/069/2025
Supersedes	SOP/BA-BE/069/2022
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 the standardized procedure for documenting all Adverse Events (AEs) occurring during the clinical phase of Bioavailability/Bioequivalence (BA/BE) studies in compliance with ICH-GCP and applicable regulatory guidelines.

2. Scope

This SOP applies to all clinical research staff involved in identifying, recording, evaluating, and reporting adverse events at the clinical site during BA/BE studies.

3. Responsibilities

• Ward Nurse: Identifies and informs CRC/Investigator of AEs observed or reported by subjects.
• Clinical Research Coordinator (CRC): Ensures timely and complete documentation of AEs in source documents and CRFs.
• Principal Investigator (PI)/Sub-Investigator: Assesses severity, causality, outcome, and signs off on AE forms.

4. Accountability

The Principal Investigator is accountable for ensuring that all adverse events are recorded accurately, evaluated for regulatory significance, and reported within specified timelines.

5. Procedure

5.1 AE Identification

1. Monitor subjects continuously during the study for:
   • Volunteer-reported symptoms
   • Clinical signs during vitals or physical exams
   • Abnormal lab or ECG findings
2. All suspected symptoms must be considered AEs until evaluated.

5.2 Documentation Standards

1. Record AEs in source documents immediately upon detection.
2. Transfer details to:
   • Annexure-1: AE Log Sheet
   • Subject CRF AE section
3. Ensure legibility, consistency, and completeness in AE records.

5.3 AE Information to Capture

1. Subject ID
2. Event term (e.g., nausea, rash)
3. Date and time of onset
4. Severity (Mild, Moderate, Severe)
5. Causality (Unrelated, Unlikely, Possible, Probable, Certain)
6. Outcome (Resolved, Ongoing, Unknown)
7. Action taken (None, Drug withdrawn, Concomitant medication, Hospitalized)

5.4 Follow-Up and Final Outcome

1. Monitor subject until resolution of AE.
2. Update all logs with:
   • Resolution date
   • Final outcome
   • Follow-up investigations if required

5.5 QA and Review

1. All AE documentation must be reviewed by QA during TMF reconciliation or audits.
2. Discrepancies between source and CRF must be reconciled and documented.

6. Abbreviations

• AE: Adverse Event
• SAE: Serious Adverse Event
• CRF: Case Report Form
• PI: Principal Investigator
• CRC: Clinical Research Coordinator

7. Documents

1. AE Log Sheet – Annexure-1
2. Subject CRF (AE Section)
3. Follow-up Forms (if applicable)

8. References

• ICH E6(R2) – Good Clinical Practice
• ICH E2A – Clinical Safety Data Management
• CDSCO GCP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: AE Log Sheet

Subject ID	AE Term	Start Date	Severity	Causality	Outcome	Action Taken	Final Date	Investigator Signature
VOL-069	Headache	17/04/2025	Mild	Possible	Resolved	None	18/04/2025	Dr. Arvind Shah

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial release	GCP implementation	QA Head
17/04/2025	2.0	Expanded AE parameters and tracking process	Audit requirement	QA Head