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Clinical Site Agreement Template

The tripartite agreement is intended to be used when the management of a commercial clinical trial is outsourced by the sponsor to a contract research organisation. The CRO mCIA is recommended by the UK Health Services, the National Institute for Health Research, the Association of British Healthcare Industries, the NHS Confederation, the Medical Schools Council, the UK Clinical Research Collaboration, the NHS R&D Forum and the Institute for Clinical Research. The sponsor has appropriate insurance coverage necessary for these trials and maintains the coverage for the rest of the trail period. Members participating in this Agreement may at any time require proof of insurance if deemed necessary. Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support clinical research cooperation involving the pharmaceutical and biotechnology industries, universities and NHS organisations across the UK. PandaTip: Clinical trials often publish their results in scientific journals and other publications. This section of this document describes the conditions for the publication of clinical trial results. PandaTip: This overview section is the standard for clinical trial agreements and describes the responsibilities of the parties concerned with regard to the ongoing monitoring and reporting of protocol changes. PandaTip: This section of the Clinical Trials Agreement Template provides you with an area in which you can document all proprietary rights between the parties as well as all other proprietary rights that participate in the Clinical Trials Agreement.

PandaTip: Sponsors of clinical trials often provide equipment or other assets, in addition to financial support. In this section of the model, you can describe in detail all the materials that the sponsor will provide during the clinical trial. Where a proposal is submitted on the basis of the model agreement, but which involves amendments, the sponsor must explain the reasons for the proposal. All clinical trials and clinical trials (including CTIMP, device studies, etc.) should be subject to a signed agreement between the sponsor and the host organisation prior to the commencement of on-site research. The Clinical Trial Agreement model for primary care research (Primary Care mCTA) sponsored by the biopharmaceutical industry has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of very active GPs, the British Medical Association, the Medical Protection Society and the UK Health Services. The Health Research Authority (HRA) supports the use of model agreements. The study begins with the approval of this contract and will be concluded either at the end of the contract or at the end of the study. Revised in February 2018, the Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) models are designed to be used without modification for industry-sponsored studies of NHS/HSC patients in hospitals across the UK Health Service. These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; They replace the national versions of 2011. The accompanying guidance notes provide further background information, an overview of changes from the 2011 releases, and further information on how and under what circumstances the models should be used.

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