equipped with BE units.

3. Responsibilities

• Study Physician: Leads emergency response and determines clinical management.
• Clinical Research Coordinator (CRC): Assists physician, maintains documentation, and communicates with relevant stakeholders.
• Nursing Staff: Provides immediate care, administers first aid or emergency drugs as instructed.
• QA Officer: Ensures all events are documented and reported appropriately.

4. Accountability

The Principal Investigator (PI) is accountable for overseeing the implementation of emergency procedures, post-event follow-up, and compliance with reporting obligations to regulatory authorities and Ethics Committees.

5. Procedure

5.1 Preparedness and Infrastructure

1. Ensure availability of:
   • Emergency crash cart with life-saving medications
   • Functional oxygen cylinders and defibrillator
   • First aid kit and IV infusion sets
2. Check emergency equipment daily and log in Annexure-1: Emergency Equipment Checklist.
3. Display emergency contact numbers and local hospital details in BE unit premises.

5.2 Identification of Medical Emergency

1. Medical emergencies may include:
   • Severe allergic reactions (e.g., anaphylaxis)
   • Chest pain, convulsions, fainting
   • Uncontrolled vomiting, abnormal vitals, or unconsciousness
2. Any staff member identifying a potential emergency must immediately alert the physician and activate the emergency response system.

5.3 Initial Emergency Response

1. Physician to assess and initiate emergency care:
   • Administer medication as per medical need
   • Ensure airway, breathing, and circulation (ABCs)
   • Monitor vitals continuously
2. Record observations in Annexure-2: Emergency Medical Handling Record.

5.4 External Referral and Hospitalization

1. If required, transfer subject to the designated hospital:
   • Use ambulance service
   • Send all relevant documents including study protocol, informed consent, and vitals chart
2. Update sponsor, Ethics Committee, and regulatory body as per reporting timelines.

5.5 Documentation and Reporting

1. Document complete chronology of the event in:
   • Annexure-2: Emergency Medical Handling Record
   • Annexure-3: Serious Adverse Event (SAE) Form (if applicable)
2. Report SAEs within 24 hours to Ethics Committee and sponsor.

5.6 Follow-up and Root Cause Analysis

1. Conduct medical follow-up until resolution or stabilization.
2. Perform Root Cause Analysis (RCA) and document in Annexure-4: Emergency Event Investigation Form.
3. Implement corrective and preventive actions as required.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• PI: Principal Investigator
• SAE: Serious Adverse Event
• RCA: Root Cause Analysis

7. Documents

1. Emergency Equipment Checklist – Annexure-1
2. Emergency Medical Handling Record – Annexure-2
3. SAE Form – Annexure-3
4. Emergency Event Investigation Form – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• Indian GCP Guidelines
• Schedule Y – Drugs & Cosmetics Rules

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 Equipment Checklist

Date	Item	Status	Checked By
17/04/2025	Oxygen Cylinder	Available	Ravi Nair

Annexure-2: Emergency Medical Handling Record

Subject ID	Date	Event Description	Actions Taken	Outcome	Handled By
VOL-092	17/04/2025	Severe nausea post-dose	IV antiemetic administered	Resolved	Dr. A. Shah

Annexure-3: SAE Form

Subject ID	Event	Onset Date	Reported To	Initial Report Date
VOL-092	Severe Vomiting	17/04/2025	EC/Sponsor	17/04/2025

Annexure-4: Emergency Event Investigation Form

Event	Root Cause	Corrective Action	Preventive Action	Verified By
Unconsciousness	Drug sensitivity	Withheld further dose	Pre-dose allergy screening	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
14/01/2022	1.0	Initial SOP Release	Safety Process	QA Head
17/04/2025	2.0	Added structured forms and referral procedures	Regulatory Compliance	QA Head