The UK Model Clinical Trial Agreement (mCTA) is the standard contract template that commercial sponsors and NHS or HSC organisations use to set up an industry-sponsored clinical trial, published and maintained via the Health Research Authority’s IRAS toolkit, and required to be used unmodified in almost all cases across England, Scotland, Wales and Northern Ireland. The model clinical trial agreement UK framework now covers seven distinct template families, from the core mCTA to devices, primary care and non-commercial variants, and the whole suite was refreshed on 28 April 2026.
In plain terms: the mCTA is a UK-wide, sector-agreed contract — not a bespoke negotiation — that fixes the legal, indemnity and financial terms between a trial sponsor (or its contract research organisation) and each participating NHS or HSC site, so that individual hospitals and trusts do not have to negotiate contract wording study by study.
- What is the UK Model Clinical Trial Agreement (mCTA)?
- ABPI model clinical trial agreement vs HRA model clinical trial agreement
- When to use the unmodified mCTA vs a bespoke agreement
- How the HRA and IRAS toolkit route studies to the right template
- Frequently asked questions
- Implications and outlook for sponsors and R&D offices
What is the UK Model Clinical Trial Agreement (mCTA)?
The mCTA is the default site agreement for commercial, industry-sponsored clinical trials of investigational medicinal products (CTIMPs) run in NHS and HSC organisations. It sits alongside a wider family of UK model agreements covering devices, primary care, non-interventional studies and non-commercial research, all hosted on the Integrated Research Application System (IRAS) website.
Under the current suite, published for use from 28 April 2026, the seven core template families are:
| Template | Typical use case | Current version |
|---|---|---|
| mCTA / CRO-mCTA | Industry-sponsored CTIMP trials in NHS/HSC hospitals | April 2026 |
| ATMP-mCTA / CRO-ATMP-mCTA | Trials of investigational advanced therapy medicinal products | April 2026 |
| Primary care mCTA (bi- and tri-partite) | Industry trials run through GP practices and other primary care sites | April 2026 |
| mCIA / CRO-mCIA | Commercial medical device clinical investigations | April 2026 |
| mNISA / CRO-mNISA | Commercial non-interventional studies | April 2026 |
| mNCA | Non-commercial interventional research (trials, devices, tissue, data) | April 2026 |
| mCCIA / CRO-mCCIA | Contracting an NHS/HSC employee as Chief Investigator | April 2026 |
Each template is designed to be used without alteration, with only the yellow-highlighted, study-specific fields completed. This is what allows an mCTA-based site agreement to be executed in days rather than the weeks or months a fully bespoke contract typically takes to negotiate clause by clause.
ABPI model clinical trial agreement vs HRA model clinical trial agreement
Sponsors and R&D teams search for both the “ABPI model clinical trial agreement” and the “HRA model clinical trial agreement” — but these are not two competing templates. They are the same lineage of document, described by its origin on one hand and its current steward on the other.
The original CRO-mCTA guidance describes how the tripartite template was developed jointly as the “NHS-ABPI-BIA Contract Research Organisation model Clinical Trial Agreement”, reflecting the historic partnership between the NHS, the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA). That is why many sponsors still call it the “ABPI mCTA” out of habit.
Today, the templates are published, version-controlled and hosted through the Health Research Authority’s IRAS toolkit, and governed by the UK Four Nations Contracting Leads Group, which reviews user feedback and decides on revisions roughly every six months. That governance and hosting arrangement is why the same document is now more accurately described as the “HRA model clinical trial agreement”. There is one current mCTA family, not a rival ABPI version and a rival HRA version to choose between.
When to use the unmodified mCTA vs a bespoke agreement
For nearly all commercial contract research, the unmodified UK template is mandatory, not optional. Under the National Directive on Commercial Contract Research, HRA and Health and Care Research Wales (HCRW) Approval is normally issued conditionally on the appropriate, unaltered template being used, and each devolved nation applies an equivalent policy position.
A bespoke or modified agreement is reserved for genuinely exceptional circumstances, primarily where no UK template exists for the specific project type. Sponsors who want to depart from the standard template must:
- Submit a formal waiver request to the HRA and HCRW, usually as part of the Approval conditions
- Set out any proposed changes clearly in the IRAS cover letter, with a tracked-change version of the template
- Provide a detailed, change-by-change rationale for each deviation
The HRA is explicit that a waiver request is “liable to add many months of central negotiation” and is unlikely to be agreed. Even where a waiver is granted, it only removes the obligation on participating NHS or HSC organisations to accept the unmodified template — individual sites remain free to propose their own terms or seek independent legal advice at the sponsor’s expense. For non-commercial research there is no equivalent statutory directive, but the same policy expectation applies: use the appropriate UK template (typically the mNCA) unmodified, or expect a prolonged review.
How the HRA and IRAS toolkit route studies to the right template
Sponsors do not have to guess which agreement applies. For studies going through HRA and HCRW Approval, the HRA Initial Assessment Letter and the subsequent Approval letter specify the correct agreement for each participating site type — whether that is an unmodified mCTA variant or an Organisation Information Document for non-commercial studies.
Two toolkits sit either side of that decision:
- The IRAS website (myresearchproject.org.uk) hosts the live template documents, version-dated guidance notes, and the definitive “Templates for supporting documents” index used to download the correct .docx file
- The Clinical Trials Toolkit (ct-toolkit.ac.uk), a UKCRC-supported routemap, walks research teams through the contracting decision points step by step, from identifying sponsorship type to selecting the matching agreement
Where a study uses a hub-and-spoke delivery model, a further layer applies: the Lead Trial Site contracts with the sponsor via an unaltered mCTA or mNCA, and then a UK template Hub and Spoke Agreement subcontracts rights and responsibilities down to each Other Trial Site. Feedback on any template is directed to the Four Nations Contracting Leads Group via [email protected], and any new studies submitted in IRAS on or after 28 April 2026 must use the April 2026 versions — earlier versions are no longer accepted.
Frequently asked questions
What is a clinical trial agreement?
A clinical trial agreement is a legally binding contract between a trial sponsor, a research site and (in some templates) the principal investigator, setting out each party’s responsibilities, indemnities and financial terms for a specific study. In the UK, most industry-sponsored trials use a standard mCTA rather than a one-off negotiated contract.
What is the NHS model CDA?
The model Confidentiality Disclosure Agreement (mCDA) is a separate UK-wide template used earlier in study set-up, before a site agreement such as the mCTA is signed. It governs the sharing of confidential feasibility information between a sponsor and prospective NHS or HSC sites, and — like the mCTA — is expected to be used unaltered.
Implications and outlook for sponsors and R&D offices
The practical implication for institutional research offices is straightforward: default to the unmodified template every time, budget waiver requests as a last resort measured in months rather than weeks, and rebuild any local contract-tracking spreadsheets around the April 2026 version numbers so that expired templates are not accidentally resubmitted through IRAS.
Because the Four Nations Contracting Leads Group reviews feedback and revises the suite roughly twice a year, sponsors and R&D offices operating in research administration functions should treat the mCTA suite as a living document set, not a one-off download, and check the IRAS templates page before every new study submission rather than relying on a cached copy from a previous trial.
