Guidance is available for HSC organisations on how to acknowledge a new commercial research project being proposed to a HSC Trust for feasibility assessment under a model Master Confidential Disclosure Agreement (mMCDA).
The guidance is available for HSC organisations to support them in quickly acknowledging when a sponsor wants to add a new study to the mMCDA.
After the mMCDA is signed between a commercial sponsor and the HSC organisation, individual studies are added to the agreement through the notification system described in schedule 1 of the mMCDA.
Confidentiality obligations in the mMCDA only apply after:
• the sponsor has notified the HSC organisation of the new study by completing and emailing schedule 1
and:
• the NHS or HSC organisation has acknowledged receipt of schedule 1
What do NHS and HSC organisations need to do?
We expect that HSC organisations set up robust procedures to ensure that they quickly acknowledge receipt of a schedule 1 notification.
Acknowledging receipt means that the sponsor or their named contract research organisation (CRO) can share study documentation to support site feasibility and set-up discussions, speeding up site set-up activities.
Whilst it is up to each HSC organisation to manage this internally, we expect that notifications are acknowledged on the day of receipt. We recommend that automatic replies are set up to act as the acknowledgement through a generic inbox.
Information is available within section 2 of the model confidential disclosure agreements associated guidance about how to set up automatic replies based on the version of Microsoft Outlook being used.
Advice and support from local IT departments may need to be sought depending on the settings in place locally, and we in HSC Innovations will also be able to advise in relation to this.
Making a more efficient and streamlined single UK standardised commercial contracting process
The expected use of the model confidential disclosure agreements and the guidance provided is part of our work on the UK Clinical Research Delivery (UKCRD) programme.
The UKCRD programme is committed to developing and mandating an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation and speed up access to research clinical trials.
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 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.