A new model Master Confidentiality Disclosure Agreement (mMCDA) has been published for commercial sponsors to contract with NHS and HSC organisations which might participate in their research studies. It is for use when a commercial sponsor wants to have a single contract in place to share confidential information for multiple research studies with one NHS / HSC organisation.  

How has it been developed?

The mMCDA has been developed by the Four Nations Contracts Leads with input received from commercial organisations and the NHS / HSC. It balances sponsors’ request to have a single contract with NHS / HSC organisations, and NHS / HSC organisations’ need to have appropriate oversight and management of research studies and CDAs they are involved with. Individual studies can be added to the agreement through a notification from the sponsor to the NHS / HSC organisation. 

When should I use it? 

Sponsors should choose to use either the mMCDA (to include multiple studies) or the mCDA (for a single study) to contract with an individual NHS or HSC organisation. CROs should continue to use the mCDA to contract with NHS / HSC organisations. 

In addition to the publication of the mMCDA:

• the mCDA guidance has been updated to include information about when and how the mMCDA should be used
• the mCDA has had minor updates made to it