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?
- PIC or research site — how do you tell the difference?
- IRAS PIC agreement vs a full CTA or mCTA: what changes?
- Which of the three model PIC agreement templates applies?
- Setting up and submitting a PIC agreement in IRAS
- Answer-first Q&A
- Implications for research offices
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.
