following adverse reactions, dosing events, or unexpected health crises.

3. Responsibilities

• Medical Officer: Responsible for proper use of the resuscitation kit during emergencies and maintaining readiness.
• Study Nurse: Assists in using kit components and documents post-use actions.
• Clinical Coordinator: Conducts monthly inspection and replenishment of the resuscitation kit.
• QA Officer: Verifies inspection records and compliance during audits.

4. Accountability

The Principal Investigator is accountable for ensuring that a fully stocked and functional resuscitation kit is available at all times during the clinical conduct of the study.

5. Procedure

5.1 Kit Location and Accessibility

1. Place the resuscitation kit in a visible and easily accessible area near the dosing and observation rooms.
2. Affix signage labeled “EMERGENCY RESUSCITATION KIT” above the kit’s location.

5.2 Resuscitation Kit Contents

1. Essential equipment and medication (see Annexure-1) must include:
   • Bag-valve mask (adult)
   • Oxygen cylinder with flowmeter and tubing
   • Defibrillator (AED or manual)
   • Syringes, IV sets, saline
   • Medications: adrenaline, antihistamines, corticosteroids, atropine
   • Glucometer and dextrose solution

5.3 Usage of Resuscitation Kit During Emergency

1. Immediately transport the kit to the patient’s bedside upon detection of emergency signs (e.g., unconsciousness, respiratory distress).
2. Medical Officer must:
   • Assess airway, breathing, and circulation (ABCs)
   • Administer oxygen and appropriate medication based on diagnosis
   • Use defibrillator if cardiac arrest is detected
3. Document actions in Annexure-2: Emergency Intervention Log.

5.4 Inspection and Replenishment

1. Inspect the kit monthly or after each use.
2. Use Annexure-3: Resuscitation Kit Inspection Checklist to verify:
   • Availability of items
   • Expiry dates of drugs
   • Functionality of equipment
3. Replace expired/used items within 24 hours.

5.5 Training Requirements

1. All medical and paramedical staff must undergo annual BLS/ACLS training.
2. Training attendance to be recorded in Annexure-4: Resuscitation Training Record.

6. Abbreviations

• BLS: Basic Life Support
• ACLS: Advanced Cardiovascular Life Support
• QA: Quality Assurance
• PI: Principal Investigator

7. Documents

1. Resuscitation Kit Contents List – Annexure-1
2. Emergency Intervention Log – Annexure-2
3. Resuscitation Kit Inspection Checklist – Annexure-3
4. Resuscitation Training Record – Annexure-4

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• American Heart Association BLS/ACLS 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: Resuscitation Kit Contents List

Item	Quantity	Expiry Date	Status
Adrenaline 1 mg/mL	5 ampoules	30/06/2025	Available
Bag-Valve Mask	1	N/A	Functional

Annexure-2: Emergency Intervention Log

Date	Subject ID	Event	Medication Given	Outcome
16/04/2025	SUB009	Syncope	Oxygen, IV fluids	Recovered

Annexure-3: Resuscitation Kit Inspection Checklist

Date	Inspected By	Expiry Check	Functional Check	Remarks
15/04/2025	Sunita Reddy	All valid	OK	No issues

Annexure-4: Resuscitation Training Record

Employee Name	Designation	Date of Training	Trainer	Remarks
Ajay Verma	Nurse	10/03/2025	Dr. Meena Joshi	Certified

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	Site preparedness policy	QA Head
17/04/2025	2.0	Added training and intervention logging procedures	Audit CAPA requirement	QA Head