CASRAI Dictionary

Tag: model non commercial agreement

  • 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.

  • MNCA Template: 2026 UK Non-Commercial Agreement

    The MNCA template is the UK-wide Model Non-Commercial Agreement published on the Integrated Research Application System (IRAS), used by non-commercial sponsors — universities, NHS trusts, and charities — to confirm a participating NHS or HSC organisation’s capacity and capability to deliver a non-commercial interventional study, and it must be used unmodified except for its yellow-highlighted schedule fields.

    The Model Non-Commercial Agreement (MNCA) is a standardised contract between a non-commercial research sponsor and each NHS or HSC organisation participating in a study, distinct from the model Clinical Trial Agreement (mCTA) used for commercially sponsored trials. Research offices searching for the current version need to know not only where to find it, but when it applies, how it differs from its commercial counterpart, and what changed in the April 2026 update to the UK’s suite of model agreements.

    What Is the MNCA (Model Non-Commercial Agreement)?

    The mNCA was first published in 2008 by the UK Clinical Research Collaboration to remove the need for bespoke legal negotiation on every non-commercial study site. It sets out the responsibilities of the sponsor and the NHS or HSC organisation, including indemnity, data protection, intellectual property, and governance oversight, in a single UK-wide template.

    “Non-commercial” in this context describes the sponsorship arrangement, not the funding source: a study funded in part by a commercial entity but sponsored by a university, NHS trust, government department, or Research Council still uses the mNCA rather than the mCTA. The agreement covers interventional research, including clinical trials of investigational medicinal products (CTIMPs), medical device studies, and other interventional designs such as trials of surgical technique.

    MNCA vs mCTA: How Do the Two Agreements Differ?

    The core distinction is sponsorship type. The mNCA applies to non-commercial sponsors; the mCTA (model Clinical Trial Agreement) applies to commercially sponsored trials, typically run by pharmaceutical or biopharmaceutical companies, and was originally developed through a Department of Health and Association of the British Pharmaceutical Industry (ABPI) collaboration. Both sit within a wider suite of UK model agreements maintained for use across all four nations.

    Agreement Full name Typical sponsor
    mNCA Model Non-Commercial Agreement University, NHS trust, charity, Research Council
    mCTA / CRO-mCTA Model Clinical Trial Agreement Pharmaceutical or biopharmaceutical company
    mCCIA / CRO-mCCIA Model Commercial Chief Investigator Agreement Commercial sponsor, with an NHS-employed chief investigator
    mCIA / CRO-mCIA Model Clinical Investigation Agreement Commercial sponsor of a medical device investigation
    mNISA / CRO-mNISA Model Non-Interventional Study Agreement Commercial sponsor of a non-interventional study

    When Must Institutions Use the Unmodified MNCA?

    For commercial contract research, the Health Research Authority’s National Directive on Commercial Contract Research makes use of the unmodified UK template agreements a formal policy mandate, and HRA and HCRW Approval are usually issued conditionally on that use. Non-commercial research carries a materially lighter obligation: there is no equivalent directive, only a policy expectation that the appropriate unmodified template is used, and departing from it risks prolonged central and site-level review rather than automatic non-approval.

    Waivers to use a modified or bespoke agreement are possible in either case but are granted only in exceptional circumstances, generally where no UK template exists for the project type. A waiver request can add many months to study set-up and, according to the HRA, is unlikely to be agreed.

    What Changed in the April 2026 Model Agreement Update?

    Updated versions of the mNCA, alongside the mCTA, mCCIA, mCIA, mNISA and the hub-and-spoke agreements, came into use on 28 April 2026, the date the reformed UK clinical trials regulations for CTIMPs took effect, alongside separate policy changes affecting non-CTIMP studies. According to the Health Research Authority, new studies submitted through IRAS on or after that date must use the April 2026 versions; earlier versions are no longer accepted for new submissions.

    Existing contracts already in place do not need to be reissued. Any new contract entered into with a participating NHS or HSC organisation from 28 April 2026 onward, however, must use the current version. The Four Nations Contracting Leads group, which oversees the model agreement suite across England, Scotland, Wales and Northern Ireland, reviews feedback and considers further amendments roughly every six months, so research offices should treat “the current mNCA” as a version that moves rather than a fixed document.

    Where the MNCA Fits Among Other IRAS Model Agreements

    Several related, non-commercial documents sit alongside the full mNCA and are easily confused with it:

    • Organisation Information Document (OID) — a lighter-weight document used for non-commercially sponsored projects at sites where a full contract is not proportionate, recording site-specific arrangements rather than standalone legal terms.
    • IRAS PIC agreement — used where a site acts only as a Participant Identification Centre, referring or identifying potential participants without delivering study procedures itself, so it carries narrower obligations than the mNCA.
    • Model non-commercial hub and spoke agreement — used where one NHS organisation coordinates delivery across several satellite sites for a single non-commercial study.

    Choosing the wrong document among these is one of the most common causes of delay at site set-up, since each is reviewed against different assessment criteria under HRA and HCRW Approval.

    Frequently Asked Questions

    What is an mNCA?

    The mNCA is the UK-wide template contract used between a non-commercial research sponsor and a participating NHS or HSC organisation. It confirms the site’s capacity and capability to deliver the study and is expected to be used without modification beyond its highlighted schedule sections.

    What is the model commercial chief investigator agreement?

    The mCCIA is used where a commercial sponsor engages a chief investigator who is employed by an NHS or HSC organisation, rather than contracting the organisation itself as the delivery site. A CRO-mCCIA variant adds a contract research organisation as a third party.

    What is the Organisation Information Document?

    The Organisation Information Document (OID) is shared with participating NHS and HSC organisations as part of the local information pack for non-commercial studies. It records agreed site arrangements and, in some cases, doubles as the contract for the study rather than sitting alongside a separate mNCA.

    What This Means for Research Offices

    The practical implication of the April 2026 update is version control, not new legal risk: institutions that continue using pre-2026 mNCA templates for new IRAS submissions will have them rejected at validation, adding avoidable delay to study set-up. Research offices should build a routine check of the IRAS templates page into contract-issuing workflows, since the Four Nations Contracting Leads group’s six-monthly review cycle means further updates are a standing possibility rather than a one-off event.

    More broadly, the mNCA’s “unmodified template plus policy expectation” model reflects a wider shift in research administration toward standardised, negotiation-light contracting — the same logic that underpins standardised data-sharing agreements and role-attribution frameworks elsewhere in the research lifecycle. Institutions that treat the mNCA as a living document, tied to the regulatory calendar rather than a static PDF, will spend less time in central review and more time delivering studies. Research offices building out an internal glossary of contracting and governance terms alongside the mNCA may also find it useful to cross-reference the CASRAI Dictionary for related research-administration terminology.

  • 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.