 What: changes have been made to model agreements
Who: commercial sponsors, Contract Research Organisations, NHS and HSC organisations
Where: UK wide (England, Wales, Scotland and Northern Ireland)
When: new model agreements to be used from Monday 28 April 2025
Changes have been made to model agreements currently available for use across the UK.
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 NHS or 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 or HSC organisation.
The new contract can also be used when the NHS Chief Investigator has an honorary contract with the NHS or 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, NHS and HSC organisations without modification from Monday 28 April 2025.
You should not use any other agreements when contracting with NHS or 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 NHS or 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 NHS 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 NHS or HSC organisation to share confidential information for a single research project.
The mMCDA should only be used between a sponsor and NHS or HSC organisation, but can be used to share confidential information for multiple research projects. The sponsor then only needs to notify the NHS or HSC organisation of any new studies, instead of signing a new agreement.
If an NHS or 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.
For any queries around the use of this agreement please email research.agreements@hra.nhs.uk
Making a more efficient and streamlined single UK standardised commercial contracting process
The changes made to these agreements are part of our 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.
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