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Updated expectations for agreements used by commercial sponsors now published
The Health Research Authority (HRA) has today (Monday 28 April 2025) announced the publication of a new model Commercial Chief Investigator Agreement (mCCIA), and model Confidential Disclosure Agreements (mCDA), both of which are expected to be used without modification
Announced in an edition of the organisation’s HRA Now bulletin, the guidance is expected to be of most use to Commercial Sponsors, Contract Research Organisations (CROs), NHS, and Health and Social Care (HSC) organisations – and for the Commercial Chief Investigator Agreement in particular, NHS staff who act as Chief Investigators for commercial research.
New model Commercial Chief Investigator Agreement published
The new model agreement is published today as part of the UK Clinical Research Delivery (UKCRD) programme’s commitment to develop and mandate an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation.
The mCCIA is for use when commercial sponsors want an NHS/HSC employee to be a chief investigator for a commercial contract clinical trial of an investigational medicinal product (CTIMP) and the sponsor wishes to contract for these services via the employing NHS/HSC organisation. The contract can also be used when the NHS Chief Investigator has an honorary contract with the NHS/HSC but they are substantively employed elsewhere, such as a university, or where the chief investigator is a partner in an independent contractor of NHS primary care services. It should be in place before the contracted Chief Investigator services start and, in any event, no later than the IRAS submission is made for regulatory approvals.
The Four Nations Contracts Leads developed the agreement at the request of industry and the NHS. The HRA, on behalf of the UK Four Nations Contracting Leads Group, received feedback on the first draft in November 2024. The version published today takes account of the comments received and of further work to develop the template that took place within UKCRD.
From 28 April 2025, the four UK governments expect that sponsors and NHS/HSC organisations will use the mCCIA without modification. Other agreements should not be used when contracting with NHS/HSC organisations to provide chief investigator services for commercial contract CTIMPs. This approach will reduce negotiation times by standardising the contract and ensuring that only project-specific elements are tailored in the template.
The HRA also received requests for a CRO version of this agreement; whilst they have not published one today, they are committed to publishing a CRO-mCCIA as soon as possible. Until then, if sponsors and CROs prefer to use a tri-partite agreement to include the CRO as a party to the agreement, they should use the mCCIA as the template and modify it accordingly. They are also considering developing chief investigator agreement templates for other study types.
More information about when we expect the mCCIA to be used is available on the IRAS website.
Model Confidential Disclosure Agreements expected to be used without modification
Confidential Disclosure Agreements (CDAs) (sometimes called non-disclosure agreements or NDAs) are legal agreements that are often used in commercial contract research to govern the sharing of confidential information from the commercial sponsor to the prospective participating NHS/HSC organisations prior to execution of the site agreement.
From 28 April 2025, the four UK governments expect that sponsors of commercial contract research wishing to enter into a CDA with a prospective NHS research site, do so by using an unmodified model CDA (mCDA) or model Master CDA (mMCDA) only. CDAs covering all Scottish sites can still be executed via NHS Research Scotland (NRS).
This new policy expectation comes from the UK Clinical Research Delivery (UKCRD) programme and forms part of the commitment to develop and mandate an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation, supporting the UK Government’s priority to streamline and reform clinical research set-up.
The aim is to speed up contracting between sponsors, or contract research organisations (CROs), and NHS/HSC organisations. This will also allow the NHS/HSC to focus resources on setting up studies.
The mCDA can be used between either a sponsor or CRO and an NHS/HSC organisation.
The mMCDA should only be used between a sponsor and NHS/HSC organisation. The sponsor then only needs to notify the NHS/HSC organisation of new research projects instead of signing a new contract, though they must still wait for the NHS/HSC organisation to indicate it has received the notification before sharing confidential information. The notification can also indicate where a CRO is involved on the sponsor’s behalf.
If an NHS/HSC organisation receives a bespoke or modified CDA, they should direct the sponsor to the policy statement on the IRAS website. Sponsors or CROs seeking further clarification may contact research.agreements@hra.nhs.uk.
Publication date: 28th April 2025
