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HRA Update: Guidance about the model Master Confidential Disclosure Agreement

Date: 21 October 2025

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

Read the guidance here: https://www.myresearchproject.org.uk/help/hlptemplatesfor.aspx#mCDA%20and%20mMCDA

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