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Standard Operating Procedure for Eligibility Verification (Inclusion/Exclusion)

Purpose

The purpose of this SOP is to establish standardized procedures for verifying the eligibility of potential participants in clinical trials by applying inclusion and exclusion criteria defined in the protocol. This ensures participant safety, data reliability, and compliance with ethical and regulatory standards.

Scope

This SOP applies to Principal Investigators, sub-investigators, study coordinators, and site staff conducting eligibility verification. It covers the process of medical evaluation, laboratory assessments, documentation, and approval of eligibility status prior to subject enrollment.

Responsibilities

• Principal Investigator (PI): Reviews and confirms participant eligibility before enrollment.
• Sub-Investigators: Conduct clinical evaluations, apply inclusion/exclusion criteria, and document findings.
• Study Coordinator: Maintains eligibility verification logs and ensures documentation completeness.
• Sponsor/CRO: Verifies eligibility compliance during monitoring visits.
• Quality Assurance Officer: Audits eligibility verification records for accuracy and compliance.

Accountability

The PI is ultimately accountable for ensuring participants meet all inclusion criteria and none of the exclusion criteria before enrollment. Sponsors are accountable for oversight through monitoring and audits.

Procedure

1. Preparation
Review the protocol-defined inclusion and exclusion criteria.
Ensure training of study staff on eligibility requirements.

2. Pre-Eligibility Assessment
Obtain informed consent prior to conducting eligibility assessments.
Collect baseline demographic and medical history data.
Schedule laboratory and diagnostic tests required for eligibility.

3. Verification of Inclusion Criteria
Confirm participant meets all mandatory inclusion criteria (e.g., age, disease condition, laboratory values).
Document findings in the Eligibility Verification Log (Annexure-1).

4. Verification of Exclusion Criteria
Assess exclusion criteria (e.g., co-morbid conditions, concurrent medications, pregnancy, previous participation in related studies).
Record disqualifications with supporting documentation.

5. Final PI Review
PI reviews all eligibility documentation.
PI signs and dates the Eligibility Checklist to confirm decision.

6. Documentation and Filing
File eligibility logs, checklists, and supporting documents in ISF and TMF.
Provide copies to sponsor/CRO during monitoring visits.

7. Screening Failures
Document participants who fail eligibility with reasons.
Ensure confidentiality and archive records as per regulations.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRO: Clinical Research Organization
• ISF: Investigator Site File
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. Eligibility Verification Log (Annexure-1)
2. Eligibility Checklist (Annexure-2)
3. Screening Failure Report (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Clinical Trial Guidance
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Ethical Guidelines for Clinical Research

Version: 1.0

Approval Section

Annexures

Annexure-1: Eligibility Verification Log

Annexure-2: Eligibility Checklist

Annexure-3: Screening Failure Report

Revision History

For more SOPs visit: Pharma SOP