CASRAI Dictionary

Tag: clinical trial agreements toolkit

  • Research Contract Template UK: 4 Types Compared

    A UK research contract template is a pre-negotiated model agreement — MTA, mCTA, MNCA or a Lambert/Brunswick collaboration agreement — chosen by the nature of the relationship between the parties, not by habit. Sending samples calls for a material transfer agreement; an NHS-regulated commercial trial calls for a model Clinical Trial Agreement; charity- or government-funded research uses the MNCA; and multi-party R&D with shared IP uses a Lambert or Brunswick collaboration agreement. Picking the wrong one causes avoidable delay, as UK funders and the NHS expect the correct template used unmodified.

    A research contract template UK researchers reach for is not one generic document but one of four distinct families, each governed by a different body with different rules on amendment. This article maps each template to the relationship it was built for.

    What counts as a UK research contract template?

    A UK research contract template is a standardised legal agreement, published and maintained by a national body (the Health Research Authority, UKRI, or the Association of Research Managers and Administrators), for a specific category of research relationship. The HRA states plainly: “there are several different model agreements, and you should use the one that is most appropriate for your study type and sponsorship arrangements.” Under the National Directive on Commercial Contract Research, HRA and Health and Care Research Wales (HCRW) Approval is typically issued conditionally on using the unmodified template — a waiver is possible only in exceptional circumstances.

    • Material Transfer Agreement (MTA) — for transferring biological or physical materials only
    • Model Clinical Trial Agreement (mCTA) family — for NHS-regulated commercial and non-interventional studies
    • Model Non-Commercial Agreement (MNCA) — for publicly or charity-funded research with no commercial sponsor
    • Collaboration agreement (Lambert Toolkit or Brunswick Templates) — for multi-party R&D where intellectual property is shared

    Material Transfer Agreements (MTA): moving materials, not money

    An MTA governs the transfer of physical or biological materials — tissue, cell lines, reagents, data-carrying media — between organisations, without itself constituting a clinical trial or a funded collaboration. Where an NHS or Health and Social Care (HSC) organisation is involved, the model Material Transfer Agreement published by the HRA is the required unmodified template. Where the transfer is purely between two universities or not-for-profit bodies, the Brunswick Material Transfer Agreement, hosted free by the Association of Research Managers and Administrators (ARMA), is the standard route.

    Use an MTA — not a collaboration agreement — whenever the relationship is a one-directional or reciprocal transfer of materials with no joint research programme, no shared funding, and no clinical intervention attached.

    Clinical Trial Agreements (mCTA): the NHS-regulated route

    An mCTA is the mandatory unmodified contract for a commercial sponsor running a regulated clinical trial at an NHS or HSC site. The family also includes the mCIA (medical devices), ATMP-mCTA (advanced therapy medicinal products), PC-mCTA (primary care) and mNISA (non-interventional commercial studies) — each scoped to a specific trial type.

    An updated suite of UK model agreements came into use on 28 April 2026, reflecting changes to the Clinical Trials Regulations that took effect the same day, per HRA and the Clinical Trials Toolkit. New IRAS submissions are expected to use the current versions.

    Template Used when Host / steward Modifiable?
    MTA (HRA) Transferring materials to/from an NHS/HSC organisation Health Research Authority No — unmodified use expected
    Brunswick MTA Transferring materials between universities/not-for-profits ARMA No — off-the-shelf template
    mCTA / mCIA / ATMP-mCTA / PC-mCTA / mNISA Commercial or non-interventional trials at NHS/HSC sites HRA + NIHR No — mandated under the National Directive on Commercial Contract Research
    MNCA Non-commercial, publicly/charity-funded research at NHS/HSC sites HRA No — policy expectation of unmodified use
    Lambert Toolkit collaboration agreements University-business R&D with shared IP GOV.UK / UKRI-endorsed Yes — a decision guide selects from several IP models
    Brunswick collaboration agreements University-university or not-for-profit R&D ARMA Limited — designed for use largely as published

    MNCA: the template for non-commercial research

    The Model Non-Commercial Agreement (MNCA) is the UK-wide template for research at NHS or HSC organisations that is funded by government, charity or academic sources rather than a commercial sponsor. Unlike commercial contract research, there is no equivalent National Directive mandating its use, but the HRA maintains a clear “policy expectation that the appropriate UK template will be used without modification,” and warns that departing from this “may result in prolonged central and participating NHS organisation review.” Administrators searching for an “mnca template” should treat it as the non-commercial counterpart to the mCTA family, not a lighter-touch version of a collaboration agreement.

    Collaboration agreements: Lambert Toolkit vs Brunswick Templates

    Collaboration agreements apply where two or more organisations jointly conduct research and need to allocate intellectual property, publication rights and liability — a fundamentally different problem from moving materials or running a regulated trial. The Lambert Toolkit, published on GOV.UK and endorsed by UK Research and Innovation (UKRI), is built for university-business collaborations: it offers a decision guide plus seven model agreements for one-to-one projects and four consortium agreements for multi-party collaborations, each reflecting a different approach to IP ownership and exploitation.

    Where both parties are universities or similar not-for-profit organisations, the Brunswick Suite of Templates, hosted by ARMA, provides an equivalent academic research collaboration agreement designed to avoid renegotiating IP terms from scratch on every project.

    • Choose the Lambert Toolkit when a business is a party and IP exploitation terms need active negotiation
    • Choose Brunswick Templates when all parties are universities or not-for-profit research organisations

    Choosing the right template by relationship type

    The decision is governed by relationship type, not by project size or funding value. Ask three questions in sequence: is anything commercial being run as a clinical trial at an NHS/HSC site (mCTA family); if not, is material simply moving between organisations with no joint programme (MTA); if not, is the research funded non-commercially at an NHS/HSC site (MNCA); and only if none of those apply — a multi-party research collaboration with shared IP — does a Lambert or Brunswick collaboration agreement apply.

    Frequently asked questions

    What is a model Clinical Trial Agreement (mCTA)?

    An mCTA is the HRA-published, NIHR-supported unmodified contract required for commercial, industry-sponsored clinical trials run at NHS or HSC organisations, mandated by the National Directive on Commercial Contract Research alongside sibling templates for devices, ATMPs and primary care.

    What is the difference between an MTA and a collaboration agreement?

    An MTA covers only the transfer of physical or biological materials between two parties with no joint research programme. A collaboration agreement — Lambert Toolkit or Brunswick — governs a shared research programme with joint intellectual property, publication rights and liability, making it a materially broader and more negotiated document.

    What is an MNCA and when is it used?

    The MNCA (Model Non-Commercial Agreement) is the UK template used when non-commercially funded research — government, charity or academic — takes place at an NHS or HSC organisation. It mirrors the mCTA’s unmodified-use expectation but applies where no commercial sponsor is involved.

    Can I modify a UK model agreement instead of using it unmodified?

    Only with a granted waiver, which the HRA warns “is liable to add many months of central negotiation” and “is unlikely to be agreed.” Any proposed modification must be disclosed in the IRAS cover letter with a tracked-change version and a change-by-change rationale.

    Implications and what to check next

    The practical takeaway is procedural discipline: identify the relationship first, select the corresponding UK template second, and reserve bespoke drafting for the rare case where no UK template exists — a justification that must itself be stated clearly in the IRAS application, since HRA guidance notes this “may expedite the review.” Following the 28 April 2026 regulatory changes, administrators should check the HRA’s model agreements page and the Clinical Trials Toolkit before assuming a previously downloaded template is still current. Institutions building internal contracting guidance should map each incoming request against these four relationship types before a bespoke agreement is drafted — this discipline is what keeps study set-up close to the pre-cleared norm rather than the multi-month waiver-negotiation outlier.

  • IRAS PIC Agreement vs CTA: When You Need One

    An IRAS PIC agreement is the contract used when an NHS or HSC organisation’s only role in a study is identifying and directing potential participants to a separate research site — not a full clinical trial agreement (CTA), which governs an organisation actually delivering the protocol. If a site only searches records, sends invitation letters, or passes on contact details without taking consent or running protocol procedures, a PIC agreement — not a CTA or mCTA — is the correct instrument.

    A Participant Identification Centre (PIC) is an NHS or HSC organisation, including an independent contractor of NHS services such as a GP practice, whose only involvement in a research project is processing personal data to identify potential participants and/or direct them to a research site. This article sets out what distinguishes a PIC agreement from a clinical trial agreement, which of the three UK model templates applies, and how to submit one through the Integrated Research Application System (IRAS).

    What is an IRAS PIC agreement?

    An IRAS PIC agreement is a UK model contract governing a Participant Identification Centre — an NHS/HSC organisation that identifies potential research participants and directs them to a separate research site, without undertaking any further research activity itself. Because the PIC processes personal data at the sponsor’s instruction purely to identify or contact potential participants, the agreement establishes a controller/processor relationship and satisfies the data-processing-agreement requirement under GDPR Article 28(3), as confirmed in Health Research Authority (HRA) guidance on UK study-wide governance criteria.

    A PIC is explicitly not a research site. It has no Principal Investigator, no Local Collaborator, and — for non-commercial studies — no Schedule of Events Cost Attribution Tool (SoECAT) or organisation information document requirement, because it carries out no protocol-specified procedures.

    PIC or research site — how do you tell the difference?

    The dividing line is activity, not intention. An organisation is acting as a PIC when it searches records against eligibility criteria and directs interested individuals elsewhere. It becomes a research site the moment it takes informed consent, performs a protocol-specified assessment (such as a screening blood test), or delivers any procedure requiring Principal Investigator oversight.

    Activity PIC role Research site role
    Search patient records against protocol eligibility criteria Yes Yes
    Send an invitation letter or outline participant information sheet Yes Yes
    Obtain informed consent to participate in the study No Yes
    Carry out a protocol-specified screening procedure No Yes
    Require a Principal Investigator No Yes

    A single legal entity cannot be both a PIC and a site for the same project at the same time — if identification activity sits within the same organisation delivering the research, the whole entity is treated as a research site and no PIC agreement is possible.

    IRAS PIC agreement vs a full CTA or mCTA: what changes?

    A clinical trial agreement (CTA), including the model Clinical Trial Agreement (mCTA) and its CRO variant, is a comprehensive contract covering the entire delivery of a study at a site: consent, protocol procedures, budget, indemnity, and Good Clinical Practice compliance. A PIC agreement covers a single, narrow function — recruitment support — and carries none of the delivery, indemnity, or capacity-and-capability obligations that a CTA requires.

    Feature IRAS PIC agreement CTA / mCTA
    Scope Identification and referral of participants only Full protocol delivery at a research site
    Legal basis Data controller/processor agreement (GDPR Art. 28(3)) Research delivery contract with indemnity and GCP obligations
    Principal Investigator required No Yes
    SoECAT / cost attribution Not required (non-commercial) Required (non-commercial)
    IRAS form question A73 (non-CTIMP) or cover letter for CTIMPs (A3) Standard site declaration

    Getting this wrong in either direction has consequences. Treating a recruitment-only site as a full CTA site over-engineers governance and delays set-up; treating an organisation that actually takes consent as a PIC understates its regulatory role and risks a governance breach — an amendment is required to reclassify a PIC as a research site, or a site as a PIC, once a project is already approved.

    Which of the three model PIC agreement templates applies?

    The UK’s Four Nations Contracts Leads maintain three template PIC agreements, published on the IRAS website. Choosing the wrong one is the most common set-up error research offices report.

    • Commercial Site-to-PIC agreement — used when a commercial sponsor’s contracted research site sub-contracts identification activity to a PIC; creates a controller/processor/sub-processor chain between sponsor, site, and PIC.
    • Non-commercial Site-to-PIC agreement (mNC-PICA site-to-PIC) — used when a non-commercial research site delegates identification to a PIC on the sponsor’s behalf.
    • Non-commercial Sponsor-to-PIC agreement (mNC-PICA sponsor-to-PIC) — used when a non-commercial sponsor contracts directly with the PIC, which is possible even where the only NHS/HSC role in the entire project is that of a PIC.

    For commercial contract research, the HRA’s National Directive on Commercial Contract Research sets a policy mandate that only the appropriate, unmodified UK template agreement is used. A waiver to depart from the template is rarely granted, is liable to add months of central negotiation, and — even where agreed — only removes the obligation on the participating organisation to accept the template unmodified.

    Setting up and submitting a PIC agreement in IRAS

    PIC arrangements must be declared in the IRAS form itself, not left to a side letter. For non-CTIMP studies, sponsors answer yes to question A73 to reveal the secondary PIC fields and enter contact details and activities for each PIC. For CTIMPs, sponsors answer yes to question A3 and list PICs already identified in a cover letter rather than in the form.

    Only the Word version of the PIC agreement should be submitted for review — not a PDF — so reviewers can compare it against the model template and confirm it is unmodified. The agreement does not need to be signed, or to carry a completed financial appendix or project support arrangements schedule, at the point of IRAS submission; it should be signed once the PIC is ready to begin identification activity and the site it supports has itself entered into an agreement.

    PIC activity can only start once every one of these three conditions is met, and the specific approval body depends on nation:

    • England and Wales — HRA and HCRW Approval issued, capacity and capability confirmed at the supported research site, and a signed PIC agreement in place.
    • Northern Ireland — HSC RD Approvals issued, capacity and capability confirmed, and a signed agreement with the HSC organisation acting as PIC.
    • Scotland — NHS R&D permission granted at both the research site and the PIC site, and a signed agreement in place.

    Answer-first Q&A

    What is a PIC agreement?

    A PIC agreement is a data-processing contract between a sponsor (or site) and an NHS/HSC organisation that identifies potential participants on the sponsor’s behalf. It establishes a controller/processor relationship under GDPR Article 28(3) and is used only where the organisation directs participants elsewhere without carrying out research activity itself.

    What is the model commercial chief investigator agreement?

    The model Commercial Chief Investigator Agreement (mCCIA) is a separate UK template used between a commercial sponsor and the NHS/HSC organisation employing the study’s Chief Investigator, with a CRO variant (mCCIA-CRO) where a clinical research organisation is a third party. It is unrelated to PIC status and applies only where an individual holds the Chief Investigator role.

    What are PIC sites in clinical trials?

    PIC sites are NHS/HSC organisations — Trusts, Boards, or independent primary care contractors such as GP practices — whose sole role in a trial is identifying and directing potential participants. They are excluded from receiving the full UK Local Information Pack and do not require a Principal Investigator, receiving instead only the documents relevant to their identification function.

    Implications for research offices

    Correctly classifying a site as a PIC rather than a research site — or vice versa — determines which template applies, whether a Principal Investigator and SoECAT are needed, and which IRAS form question captures the arrangement. Sponsors should decide PIC use at the feasibility stage and document each PIC’s proposed activity precisely in the IRAS form. As multi-site, recruitment-heavy designs become more common in UK research administration practice, getting this classification right at set-up avoids the amendment cycle that reclassification after approval requires.

  • Model Clinical Trial Agreement UK Guide (2026)

    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)?

    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.