{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/sop-for-uk-cta-notifications-via-national-systems-post-brexit”
},
“headline”: “SOP for UK CTA/Notifications via National Systems (Post-Brexit)”,
“description”: “This SOP describes the procedures for submitting Clinical Trial Authorisations (CTAs) and notifications to the MHRA via UK national systems in the post-Brexit regulatory environment. It ensures compliance with UK-specific requirements for clinical trial approval and oversight.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}

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

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

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

References

• MHRA Guidance – Clinical Trial Applications in the UK
• MHRA Official Website
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: CTA Submission Log

Annexure-2: CTA Query Response Log

Annexure-3: Amendment Submission Log

Annexure-4: End-of-Trial Notification Log

Annexure-5: Archiving Log

Revision History

For more SOPs visit: Pharma SOP