DEADLINE: 30 November 2024
The Health Research Authority (HRA) and devolved administrations are looking for feedback on a new draft of a model Commercial Chief Investigator Agreement (mCCIA).
What is the Model Commercial Chief Investigator Agreement (mCCIA) for?
The new template will allow commercial organisations to contract with HSC/NHS organisations which provide a Chief Investigator (CI) for a commercial clinical trial of an investigational medicinal product (CTIMP). The CI may be substantively employed by the HSC/NHS organisation, or they might be employed through an honorary or academic contract.
In the future, we hope to develop similar templates to contract CI services for other types of commercial research. The mCCIA isn’t designed to be used when contracting directly with universities or with CIs as private individuals.
The new contract will remove the need for bespoke agreements and minimise local negotiation of contractual terms. The draft template includes a proposed funding model, which consists of a number of optional CI services to be paid upon execution of the agreement, or some which could be paid annually or upon conclusion of the agreement. The template also includes suggested timings for these services, as well as an hourly rate.
The services to be contracted are at the discretion of the sponsor and will differ between research projects. Our ambition is to standardise contractual terms and the funding model, meaning that it will be quicker and easier for commercial organisations to procure CI services from HSC/NHS organisations.
Development
The new draft agreement has been developed by Contracts Leads from England, Scotland, Wales and Northern Ireland, as a result of feedback from pharmaceutical companies.
The development of the mCCIA template supports the government’s commitment to making it easier to set up clinical research in the HSC through the recovery, resilience and growth programme, and its response to Lord O’Shaughnessy’s review into the set-up of commercial clinical research.
Feedback
A small number of commercial organisations have helped develop the draft template, and we are now looking for comments from the wider community about its suitability for use with commercial CTIMPs.
We are asking for comments on this current draft.
We are also interested in understanding how the template could be changed to be suitable for non-CTIMP commercial studies, so that we can consider how we support CI contracting for these studies in future.
Further information and the draft template is now available on the HRA website.
Please provide any comments you have by email, including comments and tracked changes within the draft template as needed, to research.agreements@hra.nhs.uk on or before 30 November 2024.
Feedback will be reviewed by the Four Nations Contracts Leads who will decide what further changes to make to the agreement. We aim to publish a version for use by the end of March 2025.
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.