SOP for HREC Approvals and Site-Specific Assessments

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Published on 22/12/2025

HREC Approvals and Site-Specific Assessments SOP

Department	Clinical Research
SOP No.	CS/TGA-HREC/174/2025
Supersedes	N.A.
Page No.	1 of 22
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Table of Contents

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

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

2. Site-Specific Assessment (SSA)

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

3. Amendments

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

4. Renewals and Continuing Review

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

5. Communication and Documentation

Maintain logs of HREC and SSA correspondence.
File all approvals, acknowledgments, and queries in TMF and ISF.
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

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

References

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: HREC Submission Log

Date	Protocol No.	Submission Type	Reference No.	Status	Submitted By
05/08/2025	AUS-2025-01	Initial Submission	HREC-1001	Approved	Rajesh Kumar

Annexure-2: SSA Status Tracker

Date	Site	Submission Date	Approval Date	Status	Submitted By
12/08/2025	Melbourne General Hospital	12/08/2025	20/08/2025	Approved	Sunita Reddy

Annexure-3: HREC/SSA Correspondence Log

Date	Type	Subject	Action Taken	Responsible
15/08/2025	Email	Query on patient information sheet	Revised document submitted	Rajesh Kumar

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for HREC approvals and site-specific assessments.	New SOP created for CTN/CTX compliance.	Head of Clinical Research

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