Standard Operating Procedure for Handling Serious Adverse Events (SAEs) in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/068/2025
Supersedes	SOP/BA-BE/068/2022
Page No.	Page 1 of 11
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To provide a clear, standardized procedure for the identification, assessment, documentation, management, and reporting of Serious Adverse Events (SAEs) in Bioavailability/Bioequivalence (BA/BE) studies.

2. Scope

This SOP applies to all clinical personnel and investigators involved in the monitoring, documentation, and reporting of SAEs that occur during BA/BE studies conducted at the clinical research unit.

3. Responsibilities

• Investigator: Evaluates and confirms SAE status, determines causality, and signs off SAE forms.
• Clinical Research Coordinator (CRC): Assists with documentation and ensures regulatory timelines are met.
• Nursing Staff: Provides initial emergency care and informs the medical team immediately.
• QA/Regulatory Affairs: Submits reports to ethics committees, sponsors, and regulatory bodies.

4. Accountability

The Principal Investigator is accountable for ensuring that all SAEs are identified promptly, managed appropriately, and reported within prescribed regulatory timelines.

5. Procedure

5.1 Definition of SAE

1. Any untoward medical occurrence that:
   • Results in death
   • Is life-threatening
   • Requires hospitalization or prolongation of hospitalization
   • Results in persistent or significant disability/incapacity
   • Is a congenital anomaly/birth defect

5.2 Identification and Initial Response

1. Nursing staff shall notify the Investigator immediately upon observation or report of any SAE-like symptoms.
2. Provide emergency medical care and stabilize the subject.
3. Document time of event and action taken in Annexure-1: SAE Initial Management Log.

5.3 Medical Assessment

1. The Investigator assesses:
   • Severity and seriousness
   • Causality (related/unrelated/possibly related)
   • Outcome and need for hospitalization
2. Details entered into Annexure-2: SAE Reporting Form.

5.4 Regulatory Reporting

1. Report to the Sponsor, Ethics Committee, and Regulatory Authority (e.g., CDSCO) within 24 hours of awareness.
2. Follow up with a detailed SAE report within 7 calendar days.
3. Maintain submission proof in Annexure-3: Regulatory Communication Log.

5.5 Follow-Up and Final Assessment

1. Conduct follow-up until resolution or stabilization of SAE.
2. Update the SAE form and CRF with final outcome and Investigator signature.
3. Attach supporting documents (discharge summary, lab results, etc.).

5.6 Review and Archival

1. All SAE forms and documentation are reviewed by QA for completeness.
2. Archived in Trial Master File (TMF) under safety documentation.

6. Abbreviations

• SAE: Serious Adverse Event
• AE: Adverse Event
• CRF: Case Report Form
• PI: Principal Investigator
• CDSCO: Central Drugs Standard Control Organization

7. Documents

1. SAE Initial Management Log – Annexure-1
2. SAE Reporting Form – Annexure-2
3. Regulatory Communication Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• ICH E2A – Clinical Safety Data Management
• CDSCO SAE Reporting 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: SAE Initial Management Log

Subject ID	Date & Time	Event Description	Immediate Action Taken	By Whom
VOL-068	17/04/2025, 09:05	Severe hypotension	Oxygen and IV fluids	Dr. Arvind Shah

Annexure-2: SAE Reporting Form

Subject ID	Event	Start Date	Severity	Causality	Outcome
VOL-068	Syncope	17/04/2025	Severe	Possibly Related	Recovered

Annexure-3: Regulatory Communication Log

Report Type	Sent To	Date Sent	By Whom	Acknowledgment
Initial SAE Report	CDSCO	17/04/2025	Nisha Verma	Yes

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial release	Study compliance	QA Head
17/04/2025	2.0	Added regulatory log, annexure details	Regulatory update	QA Head