Standard Operating Procedure for Emergency Protocol Activation in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/134/2025
Supersedes	SOP/BA-BE/134/2022
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 a clear and effective procedure for the activation and management of emergency protocols during the conduct of BA/BE studies in order to ensure immediate response, subject safety, and adherence to regulatory obligations.

2. Scope

This SOP is applicable to all staff at clinical and bioanalytical trial facilities involved in the conduct of BA/BE studies during any medical, technical, or environmental emergency.

3. Responsibilities

• Principal Investigator (PI): Oversees emergency management and ensures subject safety.
• Medical Officer: Provides immediate medical care and documents clinical management.
• Study Coordinator: Assists in communication, coordination, and execution of response activities.
• QA Personnel: Ensures all emergency actions are documented and reviewed per GCP and site SOPs.

4. Accountability

The Clinical Operations Head is accountable for ensuring timely activation, documentation, and reporting of emergency procedures in accordance with regulatory and ethical guidelines.

5. Procedure

5.1 Definition of Emergency

1. Medical emergencies (e.g., severe allergic reaction, cardiac arrest, seizures)
2. Operational emergencies (e.g., power failure, equipment breakdown)
3. Environmental hazards (e.g., fire, flooding, gas leaks)

5.2 Activation of Emergency Protocol

1. Any staff member identifying an emergency must immediately inform the Medical Officer or PI.
2. Activate Annexure-1: Emergency Protocol Activation Checklist.
3. Use public announcement system or designated emergency signal where applicable.

5.3 Subject Management During Emergency

1. Stabilize affected subject(s) using emergency equipment (e.g., oxygen, defibrillator).
2. Move subject to designated emergency care room.
3. Document event in Annexure-2: Emergency Incident Report Form.
4. Inform local emergency medical services if required.

5.4 Evacuation and Site Safety

1. Follow Annexure-3: Site Evacuation Plan in case of fire or environmental threat.
2. Ensure all subjects and staff evacuate in an orderly manner.
3. Assemble at pre-identified muster points and perform headcount.

5.5 Communication and Notification

1. Notify:
   • Sponsor/monitor within 24 hours
   • IEC/IRB within the required reporting timeline
   • Regulatory authority (e.g., CDSCO) for SAEs or critical incidents
2. Use Annexure-4: Regulatory Notification Form.

5.6 Post-Emergency Review and CAPA

1. Conduct emergency debrief within 48 hours with all involved staff.
2. Initiate CAPA using Annexure-5: Emergency CAPA Log.
3. Review procedures to identify gaps or retraining needs.

6. Abbreviations

• PI: Principal Investigator
• IEC: Institutional Ethics Committee
• SAE: Serious Adverse Event
• CAPA: Corrective and Preventive Action
• CDSCO: Central Drugs Standard Control Organization

7. Documents

1. Emergency Protocol Activation Checklist – Annexure-1
2. Emergency Incident Report Form – Annexure-2
3. Site Evacuation Plan – Annexure-3
4. Regulatory Notification Form – Annexure-4
5. Emergency CAPA Log – Annexure-5

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• WHO Emergency Response Framework

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Emergency Protocol Activation Checklist

Step	Description	Status	Initials
1	Identify and report emergency	Completed	SR
2	Alert medical response team	Completed	AV

Annexure-2: Emergency Incident Report Form

Date	Time	Type of Emergency	Subject ID	Description	Action Taken
16/04/2025	11:30 AM	Anaphylaxis	SUB012	Allergic reaction post-dose	Administered epinephrine

Annexure-3: Site Evacuation Plan

Zone	Exit Route	Muster Point	Supervisor
Dosing Room	North Stairwell	Assembly Zone A	Meena Joshi

Annexure-4: Regulatory Notification Form

Notified To	Date	Mode	Details Sent	Acknowledged By
IEC Chair	16/04/2025	Email	SAE Report, PI statement	Dr. Ramesh Kumar

Annexure-5: Emergency CAPA Log

Date	Issue	Root Cause	Corrective Action	Preventive Action	Status
17/04/2025	Delayed response	Alarm not triggered	Manual alert issued	Install new alert system	Ongoing

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
05/01/2022	1.0	Initial SOP release	Trial SOP setup	QA Head
17/04/2025	2.0	Added structured annexures and evacuation protocols	Inspection feedback	QA Head