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Standard Operating Procedure for HRA/REC Interface and UK Site Approvals

Purpose

The purpose of this SOP is to establish procedures for submitting, tracking, and managing clinical trial applications and communications with the Health Research Authority (HRA) and Research Ethics Committees (RECs) in the United Kingdom. It ensures that site approvals are obtained and maintained in accordance with UK-specific regulations and Good Clinical Practice (GCP).

Scope

This SOP applies to sponsors, CROs, investigators, and regulatory affairs staff involved in submissions to HRA and RECs for trial approvals. It covers initial submissions, REC communications, site-specific assessments (SSA), and documentation of approvals in the Trial Master File (TMF).

Responsibilities

• Sponsor: Oversees all REC/HRA submissions and ensures compliance with approval timelines.
• CRO: Supports preparation and submission of IRAS applications to HRA/RECs.
• Investigator: Provides site-level documents for REC review and site approval.
• Regulatory Affairs: Manages REC communications and maintains regulatory documentation.
• QA: Verifies compliance of HRA/REC submissions and approvals with UK regulations.

Accountability

The Sponsor’s Regulatory Affairs Head is accountable for ensuring timely and complete HRA/REC approvals for UK clinical trial sites.

Procedure

1. Preparation of Submissions
1.1 Complete Integrated Research Application System (IRAS) forms for initial application.
1.2 Attach trial protocol, informed consent forms, Investigator’s Brochure, and other required documents.
1.3 Record in HRA/REC Submission Log (Annexure-1).

2. REC Review and Communication
2.1 Track communications from REC and respond to requests for information promptly.
2.2 Record discussions and clarifications in REC Communication Log (Annexure-2).

3. Site-Specific Assessments (SSA)
3.1 Submit site-specific documents for approval (PI CV, facilities checklist, insurance).
3.2 Record in SSA Approval Log (Annexure-3).

4. Approval and Documentation
4.1 File approval letters in TMF and ISF.
4.2 Communicate approvals to site staff prior to initiation.
4.3 Record in Approval Documentation Log (Annexure-4).

5. Ongoing Compliance
5.1 Maintain records of continuing approvals and renewals.
5.2 Record updates in Continuing Review Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• HRA: Health Research Authority
• REC: Research Ethics Committee
• IRAS: Integrated Research Application System
• SSA: Site-Specific Assessment
• TMF: Trial Master File
• ISF: Investigator Site File
• CRO: Contract Research Organization
• QA: Quality Assurance

Documents

1. HRA/REC Submission Log (Annexure-1)
2. REC Communication Log (Annexure-2)
3. SSA Approval Log (Annexure-3)
4. Approval Documentation Log (Annexure-4)
5. Continuing Review Log (Annexure-5)

References

• HRA Guidance – Approvals and Amendments
• Research Ethics Committees (RECs) Overview
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: HRA/REC Submission Log

Annexure-2: REC Communication Log

Annexure-3: SSA Approval Log

Annexure-4: Approval Documentation Log

Annexure-5: Continuing Review Log

Revision History

For more SOPs visit: Pharma SOP