Contracts and Agreements
Trial Planning Phase
Contracts & Agreements follows the Feasibility & Investigator Selection station and precedes the Final Protocol station. This process occurs in parallel with Funding Secured, Trial Master File, Trial Registration, and Confirm Sponsor. Contracts & Agreements is good practice and is relevant to all trials. This station is part of the 'trial planning phase' group of stations.
Contracts and Agreements
Many parties may be involved in the conduct and management of a clinical trial, and each party must have a clear understanding of their responsibilities. Contracts and agreements should be in place before the start of a trial and should be subject to periodic review to ensure they remain up to date and relevant.
In their Sponsor Oversight Part 1 blog, the Medicines and Healthcare products Regulatory Agency (MHRA) provide information on what should be included in contracts and agreements.
The Health Research Authority (HRA) has published an updated suite of model agreements. These include a new version of the model Non-Commercial Agreement (mNCA) in IRAS, along with updated Guidance Notes (.PDF). The new model agreements reflect changes to the Clinical Trials Regulations that took effect on 28 April 2026.
For commercial trials, a suite of updated model clinical trial agreements are available on the IRAS webpage.
Agreements can be formed at many levels: internal or external, legal or non-legal. In addition to the model clinical trial agreements, several other types of agreements may apply. Examples include:
- NIHR Collaboration Agreements
- NIHR Intellectual Property Agreements
- NIHR Model Material Transfer Agreements
- Commercial and non-commercial Hub and Spoke Agreements
- Funding Agreements
- Service Level Agreements with external suppliers
- Co-Sponsorship Agreements
- Pharmacy Technical Agreements covering processes applied to the IMP, including packaging, manufacturing, and radiolabelling.
Further Reading
- Costing and contracting using National Contract Value Review (NCVR): The UK’s standardised approach to costing and contracting for commercial contract research.
- NIHR Global Health Contracting: An example of a research contract.
- NIHR IP and Commercialisation Guidance: Information on how the NIHR ensures IP is protected.