CASRAI Dictionary

Tag: clinical trial site 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.

  • Clinical Trial Agreements Explained: Structure, Parties and Sign-Off

    A clinical trial agreement (CTA) is the legally binding contract that fixes how a trial will run, who pays for what, who owns any resulting intellectual property, and who carries liability if something goes wrong. It is negotiated between the sponsor (or its contract research organisation) and the research site, and it must be fully executed before the first participant is recruited.

    A clinical trial agreement is the contract that allocates the legal, financial and operational responsibilities for conducting a specific clinical study between a sponsor and a research institution or investigator. Research administrators new to clinical contracting encounter the CTA as the single document that everything else — costings, indemnity cover, publication clearance, data ownership — hangs off.

    What is a clinical trial agreement?

    A clinical trial agreement is a written contract, not a protocol or an ethics approval. It sits alongside — but is legally distinct from — the study protocol, the participant information sheet, and any regulatory or ethics sign-off. Its function is purely contractual: it converts the scientific plan for a trial into binding obligations that a court could enforce.

    Every jurisdiction that runs interventional trials of medicinal products requires one. In the UK, a CTA (or its non-commercial equivalent) must be in place before a site can open to recruitment under the UK Clinical Trials Regulations, and the Health Research Authority treats a missing or incomplete agreement as a start-up blocker, not a formality to be finished later.

    Who are the parties to a clinical trial agreement?

    Most CTAs involve three or four distinct parties, each with a different legal interest in the trial. The sponsor initiates, funds and takes overall responsibility for the trial; the research site (a hospital, university, or NHS trust) hosts the study and employs the staff who run it; and the principal investigator is the named clinician or academic accountable for day-to-day conduct at that site.

    • Sponsor — a pharmaceutical, biotech or medical device company, or an academic institution acting as sponsor for investigator-led research.
    • Contract research organisation (CRO) — frequently contracted by the sponsor to manage set-up, monitoring and payments; in tripartite UK model agreements, the CRO can be a direct signatory alongside the sponsor and the site.
    • Research site / host institution — the legal entity (NHS trust, university, or independent hospital) that signs on behalf of the department running the study.
    • Principal investigator — named in the agreement but usually not a contracting party in their personal capacity; their obligations run through their employing institution.

    The CITI Program summarises the arrangement precisely: a CTA “serves as a legally binding contract between a sponsor, site, and researcher, and outlines each party’s responsibilities and obligations for the clinical trial.”

    What clauses does a clinical trial agreement cover?

    A CTA is built from a fixed set of recurring clauses, and administrators new to the process should expect negotiation to concentrate almost entirely on four of them: indemnity, intellectual property, publication rights, and data/record access. The rest are usually more mechanical.

    Clause What it fixes Typical friction point
    Indemnity and insurance Who compensates whom for harm, negligence, or breach Sponsor indemnity wording vs institutional NHS indemnity schemes
    Intellectual property Ownership of background IP vs new inventions arising from the trial Background IP retained by originating party; foreground IP terms vary by contract type
    Publication rights When and how results may be published or presented Sponsor review period vs researcher’s right to publish negative results
    Confidentiality Protection of proprietary protocols, data and trial materials Duration of confidentiality obligations after trial closure
    Financial terms Budget, payment schedule, and cost recovery Per-patient costs vs milestone-linked payment triggers
    Data and record-keeping Access, retention and audit rights over trial records Regulatory retention periods vs institutional data-governance policy
    Subject injury Care and compensation for participants harmed by the trial Allocation of liability between sponsor and clinical negligence cover

    Peer-reviewed research backs up why these clauses matter operationally, not just legally: a quantitative study published via Cambridge Core (Lawrence et al.) found that standardised agreement templates measurably reduce multisite trial start-up time compared with bespoke, clause-by-clause negotiation.

    Commercial CTA or non-commercial agreement — which applies?

    Which template an administrator reaches for depends on who is funding the trial, not on the disease area or design. This distinction is UK-specific but the underlying logic — industry-funded work uses a different contracting route to grant-funded academic work — recurs across most national research systems.

    Feature Model Clinical Trial Agreement (mCTA) Model Non-Commercial Agreement (mNCA)
    Funder Pharmaceutical, biotech or device company Grant body, charity, or NIHR/UKRI funding
    Publisher ABPI / HRA UK-wide model suite UK-wide non-commercial model agreement suite
    IP default position Sponsor typically retains foreground IP Host institution typically retains IP
    Common signatories Sponsor, CRO, NHS trust Funder, NHS trust, sometimes co-sponsoring university

    The Health Research Authority confirmed on 28 April 2026 that it had issued an updated suite of UK model agreements to reflect changes to the UK Clinical Trials Regulations, covering both commercial and non-commercial templates. The NIHR confirms that model agreements are one of the UK-wide tools institutions use alongside the National Contract Value Review when setting per-patient trial costs. The Association of the British Pharmaceutical Industry separately maintains a tripartite Model Generic Clinical Trial Agreement for industry-sponsored research delivered through NHS hospitals and managed by CROs.

    How is a CTA negotiated and signed off?

    Sign-off follows a predictable sequence: the sponsor or CRO issues a draft (usually a model agreement where one applies), the institution’s research and innovation office reviews it against institutional policy, legal counsel on both sides negotiate the contested clauses, and the agreement is executed by an authorised signatory at the institution — rarely the investigator personally.

    • Draft issued, typically based on a national model template where the funder type allows it.
    • Institutional review against local indemnity, IP and data-governance policy.
    • Negotiation of contested clauses — indemnity and publication rights are the most common sticking points.
    • Legal execution by the institution’s authorised signatory, not the principal investigator.
    • Filing alongside ethics approval and regulatory documentation before site activation.

    Using an unamended model agreement removes most of this negotiation entirely, which is precisely why the HRA and NIHR continue to maintain and update the UK-wide model suite rather than leaving every trial to bespoke drafting.

    Common questions on clinical trial agreements

    What is a clinical trials agreement?

    A clinical trials agreement is a legally binding contract between a sponsor, a research site and an investigator that fixes each party’s responsibilities before a study begins. It covers funding, indemnity, intellectual property, publication rights and data access, and must be executed before recruitment starts.

    What is the difference between a CTA and a CRA?

    A CTA (clinical trial agreement) is the contract governing a study; a CRA (clinical research associate) is a person who monitors trial conduct and compliance at sites. One is a legal document; the other is a job role responsible for oversight and monitoring within the trial.

    Who develops the clinical trial agreement?

    The sponsor or its CRO typically issues the first draft, often a national model agreement where one is available for the funding type. The host institution’s research office and legal counsel then negotiate amendments before an authorised institutional signatory executes the final version.

    What this means for research administrators

    The direction of travel in the UK is towards standardisation, not bespoke drafting. The HRA’s April 2026 update to the model agreement suite, and the NIHR’s continued linkage of model contracts to the National Contract Value Review, push institutions towards unamended templates as the default and bespoke drafting as the justified exception.

    The practical takeaway: identify the funding type first — commercial sponsor versus non-commercial funder — before selecting a template, route indemnity and publication-rights clauses to legal review early, and treat the CTA as a live governance document, filed and retrievable alongside ethics approval for the trial’s life, not a one-off signing formality.

    The CTA sits within a wider set of research administration obligations spanning ethics, finance and compliance sign-off — treating it in isolation from that broader governance process is the most common source of late-stage delay.