Standard Operating Procedure for Emergency Medical Resuscitation Kit Use in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/136/2025 |
| Supersedes | SOP/BA-BE/136/2022 |
| 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 the procedure for maintaining and using the Emergency Medical Resuscitation Kit at clinical sites conducting BA/BE studies in order to ensure immediate availability and proper use of life-saving equipment and medication during medical emergencies.
2. Scope
This SOP applies to all clinical research sites and medical personnel involved in conducting BA/BE trials where human subjects may require urgent medical resuscitation 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
- Place the resuscitation kit in a visible and easily accessible area near the dosing and observation rooms.
- Affix signage labeled “EMERGENCY RESUSCITATION KIT” above the kit’s location.
5.2 Resuscitation Kit Contents
- 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
- Immediately transport the kit to the patient’s bedside upon detection of emergency signs (e.g., unconsciousness, respiratory distress).
- Medical Officer must:
- Assess airway, breathing, and circulation (ABCs)
- Administer oxygen and appropriate medication based on diagnosis
- Use defibrillator if cardiac arrest is detected
- Document actions in Annexure-2: Emergency Intervention Log.
5.4 Inspection and Replenishment
- Inspect the kit monthly or after each use.
- Use Annexure-3: Resuscitation Kit Inspection Checklist to verify:
- Availability of items
- Expiry dates of drugs
- Functionality of equipment
- Replace expired/used items within 24 hours.
5.5 Training Requirements
- All medical and paramedical staff must undergo annual BLS/ACLS training.
- 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
- Resuscitation Kit Contents List – Annexure-1
- Emergency Intervention Log – Annexure-2
- Resuscitation Kit Inspection Checklist – Annexure-3
- 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 |