We are helping to reduce the time, cost and resources needed to set up health and social care research in the UK by launching new templates for commercially sponsored studies.
The HRA has published two new model agreement templates which organisations carrying out research can use to draw up a contract with NHS sites involved in their study. Using the template without changing the wording prevents lots of legal review and negotiation from happening. It also reduces time spent on paperwork and helps research to start more quickly.
This work forms part of our contribution to the UK Vision for Clinical Research Delivery.
The templates fall into two categories:
- the Model Confidentiality Disclosure Agreement (mCDA) template is designed for use by companies with potential NHS sites when they wish to agree the handling of study-specific confidential information during early feasibility discussions for commercial contract research.
- the Model Non-Interventional Study Agreement (mNISA) and Clinical Research Organisation mNISA (CRO-mNISA) are the first UK templates designed for use with non-interventional commercial research with NHS research participants.
Further detailed information can be found in our operational update HRA Now.