SOP for UK CTA/Notifications via National Systems (Post-Brexit)

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Published on 21/12/2025

Standard Operating Procedure for UK CTA/Notifications via National Systems (Post-Brexit)

SOP No.	CR/OPS/160/2025
Supersedes	NA
Page No.	X of Y
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

Purpose

The purpose of this SOP is to define the process for submitting Clinical Trial Authorisations (CTAs) and related notifications to the

Medicines and Healthcare products Regulatory Agency (MHRA) via UK national systems, in accordance with post-Brexit regulatory requirements. This ensures that trials conducted in the UK comply with local legislation, independent of EU systems.

Scope

This SOP applies to sponsors, CROs, regulatory affairs, investigators, and QA staff involved in clinical trials in the United Kingdom. It covers initial CTA submission, substantial amendments, end-of-trial notifications, and other regulatory communications required under MHRA guidance.

Responsibilities

Sponsor: Prepares and submits CTA applications, amendments, and notifications via the MHRA national system.
CRO: Supports preparation of submissions and monitors MHRA communications.
Investigator: Provides essential site and investigator information required for CTA approval.
Regulatory Affairs: Coordinates submissions, tracks timelines, and ensures compliance with MHRA requirements.
QA: Audits submissions and maintains TMF documentation of all regulatory interactions.

Accountability

The Sponsor’s Regulatory Affairs Head is accountable for ensuring that all UK CTA submissions and notifications comply with MHRA requirements in the post-Brexit environment.

Procedure

1. CTA Preparation and Submission
1.1 Compile CTA application including protocol, Investigator’s Brochure, IMPD, and supporting documents.
1.2 Submit via the MHRA national system (e.g., Combined Review Service).
1.3 Document in CTA Submission Log (Annexure-1).

2. CTA Acknowledgment and Queries
2.1 Monitor MHRA portal for acknowledgment and requests for information.
2.2 Respond to MHRA queries within specified timelines.
2.3 Record in CTA Query Response Log (Annexure-2).

3. Substantial Amendments
3.1 Submit amendments to MHRA via the national system.
3.2 Track approval timelines.
3.3 Document in Amendment Submission Log (Annexure-3).

4. End-of-Trial Notifications
4.1 Submit end-of-trial notification within 90 days of trial conclusion.
4.2 For early termination, submit within 15 days.
4.3 Record in End-of-Trial Notification Log (Annexure-4).

5. Archiving and Documentation
5.1 File all submission documents, approvals, and communications in TMF.
5.2 Maintain inspection readiness.
5.3 Record in Archiving Log (Annexure-5).

Abbreviations

SOP: Standard Operating Procedure
CTA: Clinical Trial Authorisation
MHRA: Medicines and Healthcare products Regulatory Agency
CRO: Contract Research Organization
QA: Quality Assurance
IMPD: Investigational Medicinal Product Dossier
TMF: Trial Master File

Documents

CTA Submission Log (Annexure-1)
CTA Query Response Log (Annexure-2)
Amendment Submission Log (Annexure-3)
End-of-Trial Notification Log (Annexure-4)
Archiving Log (Annexure-5)

References

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, Regulatory Affairs Specialist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Regulatory Affairs

Annexures

Annexure-1: CTA Submission Log

Date	Protocol ID	Submission Type	Submitted By	Status
01/09/2025	UKCTA-2025-01	Initial CTA	Reg Affairs	Submitted

Annexure-2: CTA Query Response Log

Date	Query	Response Submitted	By	Status
03/09/2025	IMP Storage Query	03/09/2025	Reg Affairs	Resolved

Annexure-3: Amendment Submission Log

Date	Protocol ID	Amendment Type	Submitted By	Status
05/09/2025	UKCTA-2025-01	Substantial Amendment	Reg Affairs	Approved

Annexure-4: End-of-Trial Notification Log

Date	Protocol ID	Notification Type	Submitted By	Status
10/09/2025	UKCTA-2025-01	End of Trial	Sponsor	Completed

Annexure-5: Archiving Log

Date	Document Type	Archived By	Location	Status
15/09/2025	CTA Submission Docs	QA	TMF	Archived

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head Regulatory Affairs

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