present during study conduct.

3. Responsibilities

• Principal Investigator (PI): Responsible for medical decision-making and authorization of hospital referral.
• Medical Officer (MO): Provides immediate medical care and stabilizes the subject on site.
• Clinical Research Coordinator (CRC): Assists in communication, documentation, and notifying sponsor and Ethics Committee.
• Site Nurse: Provides first aid and supports the medical team during emergency management.
• Security & Admin Team: Assists with ambulance coordination and evacuation procedures.

4. Accountability

The Medical Director and Head of Clinical Operations are accountable for ensuring readiness and compliance with emergency management procedures at all times.

5. Procedure

5.1 Emergency Preparedness

1. Ensure availability of:
   • Emergency Medical Resuscitation Kit (Annexure-1)
   • Oxygen cylinders and pulse oximeter
   • Fully equipped ambulance with stretcher and paramedic staff
2. Daily checks of emergency equipment must be recorded in Annexure-2: Emergency Equipment Checklist.
3. Conduct mock drills every 6 months and document in Annexure-3: Emergency Drill Log.

5.2 Identification of Emergency

1. Any of the following constitutes a medical emergency:
   • Syncope, seizure, respiratory distress
   • Anaphylaxis, cardiac arrest
   • Severe allergic reaction, uncontrolled bleeding
   • Unexpected loss of consciousness or unresponsiveness
2. The nearest staff must immediately alert the MO and PI using emergency intercom or direct call.

5.3 Immediate Response and Stabilization

1. The MO assesses the subject’s Airway, Breathing, and Circulation (ABC protocol).
2. Initiate emergency care:
   • Administer oxygen
   • Perform CPR if necessary
   • Use Epinephrine in anaphylactic shock (0.3–0.5 mg IM)
   • IV fluids for hypotension
3. Document vital signs every 2 minutes during intervention.

5.4 Transfer to Hospital

1. Prepare Annexure-4: Medical Transfer Note with subject details, vitals, treatment given.
2. Transport subject to designated hospital in coordination with ambulance team.
3. A trained medical representative should accompany the subject with all relevant records.

5.5 Communication and Notification

1. Notify:
   • Sponsor – within 2 hours (Annexure-5: Emergency Communication Log)
   • Ethics Committee – within 24 hours using standard SAE format
2. CRC to initiate an SAE form and compile a complete dossier (medical records, PI assessment, hospital notes).

5.6 Post-Emergency Review and CAPA

1. Conduct Root Cause Analysis (RCA) and CAPA for all medical emergencies within 72 hours (Annexure-6: Emergency Review Form).
2. Review must include:
   • Event cause and response timeline
   • Lessons learned and preventive recommendations

5.7 Training and Records

1. All medical and clinical staff must be trained in BLS/ACLS annually.
2. Maintain training attendance in Annexure-7: Medical Emergency Training Log.

6. Abbreviations

• MO: Medical Officer
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• EC: Ethics Committee
• SAE: Serious Adverse Event
• CAPA: Corrective and Preventive Action

7. Documents

1. Emergency Resuscitation Kit Checklist – Annexure-1
2. Emergency Equipment Checklist – Annexure-2
3. Emergency Drill Log – Annexure-3
4. Medical Transfer Note – Annexure-4
5. Emergency Communication Log – Annexure-5
6. Emergency Review Form – Annexure-6
7. Medical Emergency Training Log – Annexure-7

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• Indian Resuscitation Council 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: Emergency Resuscitation Kit Checklist

Item	Quantity	Status	Checked By
Epinephrine 1mg/mL	5 vials	Available	Sunita Reddy
Oxygen Mask with Tubing	2	Available	Sunita Reddy

Annexure-2: Emergency Equipment Checklist

Date	Equipment	Status	Remarks	Checked By
16/04/2025	Defibrillator	Functional	Battery charged	Vinay Pawar

Annexure-3: Emergency Drill Log

Date	Scenario	Outcome	Trainer
01/03/2025	Syncope during sampling	Handled as per SOP	Dr. Ajay Verma

Annexure-4: Medical Transfer Note

Subject ID	VOL1201
Vitals	BP: 90/60 mmHg, HR: 110 bpm
Treatment Given	IV fluids, O2 support
Referred To	Sparsh Hospital, Mumbai

Annexure-5: Emergency Communication Log

Date	Notified To	Mode	Acknowledged By
17/04/2025	Sponsor Medical Monitor	Email	Dr. Neha Iyer

Annexure-6: Emergency Review Form

Date	18/04/2025
Event Summary	Severe hypotension during post-dose monitoring
Root Cause	Delayed hydration pre-dose
CAPA	Ensure hydration at least 2 hours pre-dose

Annexure-7: Medical Emergency Training Log

Name	Designation	Training Date	Trainer
Rajesh Kumar	MO	10/02/2025	Dr. Priya Menon

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
17/04/2025	2.0	Annexures updated, expanded emergency procedures	Inspection readiness	QA Head