mCDA update
The March 2023 mCDA and associated guidance are now available on the IRAS website.
Feedback on the previous version was received from commercial sponsors, CROs and NHS organisations. The feedback was reviewed by the Four Nations Contracts Leads to decide which changes to make to the UK-wide template.
The main change to be aware of is an amendment to the template to make sure it is suitable for a wider range of commercial study types, in addition to clinical trials.
We strongly recommend that commercial sponsors and CROs use the March 2023 version of the mCDA to share confidential study information with potentially participating NHS organisations.
If bespoke confidentiality agreements are used it will take longer to contract with NHS organisations.
It is at the discretion of NHS organisations to decide whether they will accept the January 2022 version of the agreement.
Expediting commercial contract research
The Department of Health and Social Care (DHSC) have published a letter asking sites to expedite the setup and delivery of commercial contract studies with immediate effect.
This aims to clear the backlog of commercial contract studies in setup and make the set-up of studies within globally competitive timelines the norm. Where sites have committed to delivery of commercial contract research, they should take urgent action to fulfil that commitment.
For the UK to be an attractive place to deliver commercial contract studies, we need to meet industry timelines – especially when it comes to regulatory approval, ethics review, and the time it takes to set-up at a site and recruit the first participants.
Th HRA will continue to work alongside DHSC, industry and partner organisations to address the barriers to set-up and delivery.
If you want to know more about how to implement this please contact the HRA queries line.
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