JCRO Research Governance

From 28 April 2026, updated UK regulations governing Clinical Trials of Investigational Medicinal Products (CTIMPs) come into effect. These changes revise the national legal framework and formally embed ICH E6(R3) Good Clinical Practice (GCP) principles into UK law.

These updates apply to all CTIMPs hosted, sponsored, or supported through JCRO — including those sponsored or hosted by GESH NHS and City St George's University of London.

• Risk-Proportionate GCP: Revised Good Clinical Practice requirements with a stronger emphasis on risk-proportionate trial conduct, Quality by Design (QbD), and data integrity.
• Investigator Responsibilities: Updated expectations for investigator oversight, delegation, and training — with clearer accountability at site level.
• Safety Reporting: Simplified and more proportionate SUSAR and Development Safety Update (DSU) reporting arrangements to reduce administrative burden without compromising safety.
• Flexible Trial Delivery: Greater flexibility to support decentralised and innovative trial elements, including remote monitoring and digital solutions.
• Legislation: Updated statutory basis under the Medicines for Human Use (Clinical Trials) Regulations (as amended, SI 2025/538).

If you work on CTIMPs within JCRO (GESH NHS or City St George's)

• Review and update study documentation as required — including protocols, participant information sheets, consent forms, monitoring plans, delegation logs, and site SOPs.
• Ensure GCP training is current. If your last GCP training was completed more than two years ago, a refresher is required via the NIHR Learning Management System.
• Sponsors or sponsor-delegated teams will contact study teams directly where specific changes are needed to maintain compliance.

If your CTIMP is externally sponsored

• Check whether your sponsor has issued transition or implementation guidance.
• Contact the JCRO Governance & Sponsorship team if you need support reviewing local processes, oversight arrangements, or safety reporting pathways.

• Updated SOPs, templates, and guidance documents — released ahead of the April 2026 go-live
• Briefings and training signposting for investigators and research teams across both organisations
• Study-specific advice and support for hosted and JCRO-sponsored CTIMPs
• Liaison with external sponsors, CTUs, and partner organisations where required

From 28 April 2026, the term 'amendment' will no longer be used for changes to approved non-CTIMP studies. All changes will be referred to as 'modifications', consistent with CTIMP terminology.

Note: Research Tissue Banks (RTBs) and Research Databases (RDBs) are excluded — the 'Notice of Substantial Amendment' form and the Amendment tab in IRAS continue to apply for these.

Three categories of modification now apply:

Sponsor responsibility: Determining whether a proposed change is significant or insignificant remains the responsibility of the sponsor, consistent with current practice.

The application, booking, and REC meeting process for non-CTIMPs remains unchanged. However, the HRA has provided greater clarity on timelines for each stage:

From 28 April 2026, substantial modification requests follow a revised review process with defined timelines. The previous option to submit a 'modified amendment' following an unfavourable opinion no longer exists — sponsors now have the opportunity to respond to a Request for Further Information before a final decision is made.

Transparency requirements for non-CTIMP clinical trials have been updated to align more closely with the new CTIMP registration rules, supporting consistency across all UK trials.