Model Confidentiality Disclosure Agreements (mCDA) – and Guidance documents

 Posted by  General news, Model Agreements
Mar 292022
 
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Confidentiality Disclosure Agreements (CDAs) (sometimes called non-disclosure agreements or NDAs) are legal agreements that are often used in commercial contract research during the early set-up of commercial contract research in NHS/HSC organisations.

The Health Research Authority (HRA) in conjunction with the Four Nations Contracting Leads Group has recently published the new model Confidentiality Agreement (mCDA).

This template model agreement is applicable to the health services in Northern Ireland, Scotland, Wales and England and should be used without modification by all commercial organisations in a research study to govern the sharing of confidential information from the commercial sponsor to the prospective participating NHS/HSC organisations prior to execution of the site agreement (For example mCTA, CRO-mCTA, mCIA, and so on).

This study specific CDA template and its associated guidance has been produced by a UK-wide partnership to help make the early sharing of information, for feasibility and site set-up purposes, clearer, more consistent, and efficient in line with the UK Vision for Clinical Research Delivery.

Developed as part of the UK Research Recovery Resilience and Growth Programme, they are available now alongside our other model agreements in IRAS.

This recommended template is a resource Sponsors can choose to use with NHS/HSC sites.  Doing so will reduce negotiation time with sites, provide assurances to both parties that their rights and responsibilities are appropriate and facilitate compliance by sites with contract terms, replacing the inconsistency of terms to which NHS/HSC organisations are currently subject.

We strongly encourage all commercial sponsors and HSC organisations to use these templates without modification for maximum speed and benefit in relation to the feasibility/site set-up phase of commercial contract research.

See the model confidentiality agreement (mCDA) and mCDA Guidance.

 

Feedback 

Questions and/or feedback from HSC/NHS organisations on the mCDA and its use should be provided to HSC Innovations at ResearchContracts@innovations.hscni.net, whereby these will be raised directly with the UK Contracting Leads group.

Assistance

For assistance with queries relating to the mCDA and other template agreements, contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact HSC Innovations.  All correspondence should be sent to ResearchContracts@innovations.hscni.net for further information and assistance.