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Standard Operating Procedure for Site Capability for Emergency Care Verification and Documentation

Purpose

The purpose of this SOP is to define the process for verifying and documenting the capability of investigator sites to provide emergency medical care during clinical trials. It ensures participant safety, compliance with DCGI/CDSCO guidelines, and readiness for handling trial-related medical emergencies in accordance with Indian GCP and NDCTR 2019.

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

1. Site Capability Assessment Log (Annexure-1)
2. Hospital Backup Documentation Log (Annexure-2)
3. Site Verification Log (Annexure-3)
4. Training Log (Annexure-4)
5. 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

Annexures

Annexure-1: Site Capability Assessment Log

Annexure-2: Hospital Backup Documentation Log

Annexure-3: Site Verification Log

Annexure-4: Training Log

Annexure-5: Audit Log

Revision History

For more SOPs visit: Pharma SOP