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“headline”: “SOP for HREC Approvals and Site-Specific Assessments”,
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“description”: “Comprehensive SOP describing workflows for obtaining Human Research Ethics Committee (HREC) approvals and Site-Specific Assessments (SSA), ensuring clinical trial start-up compliance with TGA and GCP.”,
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HREC Approvals and Site-Specific Assessments SOP

Purpose

This SOP outlines the standardized processes for obtaining Human Research Ethics Committee (HREC) approvals and conducting Site-Specific Assessments (SSA) before trial initiation. It ensures compliance with TGA regulations, GCP principles, and institutional governance requirements for ethical trial conduct in Australia.

Scope

This SOP applies to all clinical trials conducted under the CTN/CTX schemes in Australia. It covers sponsor, CRO, and investigator responsibilities for submitting documents to HRECs, managing SSA applications, coordinating site governance approvals, and maintaining documentation in TMF and ISF. It also includes communication pathways with institutions, sponsors, and TGA.

Responsibilities

• Principal Investigator (PI): Submits site documents for SSA, responds to HREC queries, and ensures site compliance with approval conditions.
• Clinical Research Coordinator (CRC): Assists in preparing submissions, maintains SSA documentation, and ensures timely renewals.
• Regulatory Affairs (RA): Oversees multi-site HREC submissions and ensures alignment with CTN/CTX submissions to TGA.
• Clinical Project Manager (CPM): Tracks timelines, manages site readiness, and ensures approvals are in place before trial start.
• Quality Assurance (QA): Audits HREC and SSA submissions to ensure compliance and inspection readiness.

Accountability

The Sponsor’s Head of Clinical Research holds accountability for ensuring that all clinical trial sites have valid HREC approvals and completed SSAs prior to activation. The PI is accountable for maintaining ongoing compliance at the site level.

Procedure

1. HREC Submission

1. Compile required documents: protocol, IB, ICFs, investigator CVs, recruitment materials, and insurance certificates.
2. Submit initial package to HREC for review and approval.
3. Record submission date, reference number, and approval status in HREC Submission Log.

2. Site-Specific Assessment (SSA)

1. Submit SSA application with local governance documents including indemnity agreements, budget, and site capabilities.
2. Ensure institutional approvals are obtained prior to participant enrollment.
3. Maintain SSA status tracker with submission, approval, and expiry dates.

3. Amendments

1. Submit substantial amendments (protocol changes, revised ICFs) to HREC and SSA offices prior to implementation.
2. Document approval acknowledgments in TMF and ISF.

4. Renewals and Continuing Review

1. Prepare annual reports for HREC and SSA renewal at least 30 days before expiry.
2. Track renewal timelines in HREC/SSA Renewal Log.

5. Communication and Documentation

1. Maintain logs of HREC and SSA correspondence.
2. File all approvals, acknowledgments, and queries in TMF and ISF.
3. Ensure availability for regulatory and institutional inspections.

Abbreviations

• HREC: Human Research Ethics Committee
• SSA: Site-Specific Assessment
• CTN: Clinical Trial Notification
• CTX: Clinical Trial Exemption
• PI: Principal Investigator
• IB: Investigator’s Brochure
• ICF: Informed Consent Form
• CRC: Clinical Research Coordinator
• TMF: Trial Master File
• ISF: Investigator Site File
• QA: Quality Assurance

Documents

1. HREC Submission Log (Annexure-1)
2. SSA Status Tracker (Annexure-2)
3. HREC/SSA Correspondence Log (Annexure-3)

References

• TGA — Clinical Trials Guidance
• NHMRC Human Research Ethics Committees
• ICH E6(R2) Good Clinical Practice

Version: 1.0

Approval

Annexures

Annexure-1: HREC Submission Log

Annexure-2: SSA Status Tracker

Annexure-3: HREC/SSA Correspondence Log

Revision History

For more SOPs visit: Pharma SOP.