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“headline”: “SOP for Site Capability for Emergency Care Verification and Documentation”,
“description”: “This SOP establishes procedures to verify and document the emergency care capability of clinical trial sites in India. It ensures subject protection, compliance with DCGI/CDSCO requirements, and readiness for trial-related medical emergencies.”,
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Published on 26/12/2025
Standard Operating Procedure for Site Capability for Emergency Care Verification and Documentation
| SOP No. | CR/OPS/147/2025 |
| Supersedes | NA |
| Page No. | X of Y |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define the process for verifying and documenting the capability of investigator sites to
Scope
This SOP applies to sponsors, CROs, investigators, and site staff engaged in clinical trials conducted in India. It covers assessment of facilities, verification of emergency preparedness, documentation of hospital backup agreements, and regulatory inspection readiness.
Responsibilities
- Sponsor: Ensures all trial sites have adequate emergency care facilities and documentation.
- Investigator: Confirms availability of emergency care services and maintains records.
- CRO: Conducts site capability verification and reports findings to sponsor.
- EC: Reviews site preparedness documentation during trial approval.
- QA: Audits site records to ensure compliance and inspection readiness.
Accountability
The Principal Investigator (PI) is accountable for maintaining and demonstrating site readiness for emergency care at all times during the trial.
Procedure
1. Site Capability Assessment
1.1 Assess availability of emergency care equipment (defibrillators, oxygen supply, crash cart).
1.2 Confirm presence of trained medical staff capable of handling emergencies.
1.3 Record in Site Capability Assessment Log (Annexure-1).
2. Hospital Backup Arrangements
2.1 Ensure documented agreements with nearby hospitals for emergency referral.
2.2 Verify signed Memorandum of Understanding (MoU).
2.3 Record in Hospital Backup Documentation Log (Annexure-2).
3. Documentation and Verification
3.1 Maintain emergency preparedness documentation in ISF and TMF.
3.2 Verify during site initiation visits.
3.3 Document findings in Site Verification Log (Annexure-3).
4. Training
4.1 Conduct site staff training on emergency preparedness procedures.
4.2 Document in Training Log (Annexure-4).
5. Inspection Readiness
5.1 Ensure records are accessible for DCGI and EC inspections.
5.2 Conduct internal QA checks and record in Audit Log (Annexure-5).
Abbreviations
- SOP: Standard Operating Procedure
- EC: Ethics Committee
- DCGI: Drugs Controller General of India
- CDSCO: Central Drugs Standard Control Organization
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
- ISF: Investigator Site File
- NDCTR: New Drugs and Clinical Trials Rules
- PI: Principal Investigator
Documents
- Site Capability Assessment Log (Annexure-1)
- Hospital Backup Documentation Log (Annexure-2)
- Site Verification Log (Annexure-3)
- Training Log (Annexure-4)
- Audit Log (Annexure-5)
References
- CDSCO – Central Drugs Standard Control Organization
- New Drugs and Clinical Trials Rules, 2019
- ICMR – National Ethical Guidelines
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Clinical Research Associate |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Principal Investigator |
Annexures
Annexure-1: Site Capability Assessment Log
| Date | Site | Equipment Verified | Verified By | Status |
|---|---|---|---|---|
| 01/09/2025 | Bangalore Site | Crash Cart + Oxygen | CRO Monitor | Compliant |
Annexure-2: Hospital Backup Documentation Log
| Date | Hospital Name | Agreement Type | Verified By | Status |
|---|---|---|---|---|
| 02/09/2025 | XYZ Hospital | MoU Signed | Investigator | Valid |
Annexure-3: Site Verification Log
| Date | Site | Verified By | Findings | Status |
|---|---|---|---|---|
| 05/09/2025 | Bangalore Site | CRO Monitor | Emergency Preparedness Verified | Accepted |
Annexure-4: Training Log
| Date | Site | Staff Trained | Trainer | Status |
|---|---|---|---|---|
| 07/09/2025 | Bangalore Site | 5 Staff | QA Officer | Completed |
Annexure-5: Audit Log
| Date | Audit Type | Performed By | Status |
|---|---|---|---|
| 10/09/2025 | Mock DCGI Inspection | QA | Compliant |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Principal Investigator |
For more SOPs visit: Pharma SOP