The Health Research Authority (HRA) and devolved administrations are looking for feedback on a new draft of a model Commercial Chief Investigator Agreement (mCCIA).
Feedback is welcome from commercial sponsors, contract research organisations, chief investigators (CIs), and the NHS / HSC organisations which employ them. The CI is the person taking overall responsibility within the UK team of researchers for the design, conduct and reporting of the study.
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.
We are now requesting further comments from the wider community about its suitability for use with clinical trials of investigational medicinal products (CTIMPs).
What is the mCCIA for?
The mCCIA is designed to be used when a commercial organisation is contracting with a NHS / HSC organisation to provide a CI for a commercially-sponsored CTIMP. The CI may be substantively employed by the NHS / HSC organisation, or they might be employed through an honorary or academic contract. The mCCIA is not designed for contracting with universities or when the commercial organisation wants to contract with a CI as a private individual.
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 NHS / HSC organisations.