Guidance for NHS organisations about the model Master Confidential Disclosure Agreement

Guidance is available for NHS and HSC organisations to support them in quickly acknowledging when a sponsor wants to add a new study to the model Master Confidential Disclosure Agreement (mMCDA).

After the mMCDA is signed between a commercial sponsor and NHS or 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 NHS or HSC organisation of the new study by completing and emailing schedule 1, and
• the NHS or HSC organisation has acknowledged receipt of schedule 1.

We expect that NHS and 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 NHS and 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.

Call to action box: Read the model confidential disclosure agreements associated guidance

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.

You can read more about our work as part of the programme on the HRA website.