From the 28th April 2025, changes have been made to the model agreements currently available for use across the UK.
Specifically, the newly published model Commercial Chief Investigator Agreement (mCCIA) and the model Confidential Disclosure Agreements (mCDAs) should be used without modification across the UK (England, Wales, Scotland and Northern Ireland).
Model Commercial Chief Investigator Agreement (mCCIA)
A new model Commercial Chief Investigator Agreement has been published.
The mCCIA is for use when commercial sponsors want an 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 HSC organisation.
The new contract can also be used when the HSC Chief Investigator has an honorary contract with the 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 no later than the IRAS submission is made for regulatory approvals.
When should the contract be used from?
The new mCCIA should be used by sponsors and HSC organisations without modification from Monday 28 April 2025.
You should not use any other agreements when contracting with HSC organisations to provide Chief Investigator services for commercial contract CTIMPs.
You can view a copy of the contract, and see more information about when it should be used, on the IRAS website.
Model Confidential Disclosure Agreement (mCDA)
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 HSC organisations prior to the site agreement.
From Monday 28 April any sponsors of commercial contract research wishing to enter into a CDA with a prospective HSC research site should only do so by using an unmodified model CDA (mCDA) or model Master CDA (mMCDA).
The mCDA can be used between either a sponsor or CRO and an HSC organisation to share confidential information for a single research project.
The mMCDA should only be used between a sponsor and HSC organisation, but can be used to share confidential information for multiple research projects. The sponsor then only needs to notify the HSC organisation of any new studies, instead of signing a new agreement.
If an HSC organisation receives a bespoke or modified CDA, they should direct the sponsor to the templates they are expected to use on the IRAS website.
The changes made to these agreements are part of the work on the UK Clinical Research Delivery (UKCRD) programme which is committed to developing and mandating an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation.
You can read more about our work as part of the programme on the HRA website.
Feedback
Questions and/or feedback from HSC organisations on the mCCIA or model CDAs and their use should be provided to HSC Innovations, whereby these will be raised directly with the UK Contracting Leads group.
Assistance
For assistance with queries relating to model template agreements, contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact ResearchContracts@innovations.hscni.net.