Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support cooperation in clinical research involving the pharmaceutical and biotechnology industries, universities and NHS organisations in the UK. If there is an agreement between the proponent and the site (including all commercially sponsored studies), it is highly recommended to use an unchanged model agreement. These agreements should be used as outlined in their accompanying guidelines. The use of the unchanged model agreement simplifies and speeds up the process of setting up the study. The UK Clinical Research Collaborations (UKCRC) model agreements have been negotiated with English law, and governance agreements in their key versions and modified versions are available for use in legal systems and administrative arrangements in Scotland, Wales and Northern Ireland. The use of a modified model agreement or an agreement not based on a model model is possible, but the proponent should be aware of any difficulties that may arise frequently, such as longer negotiating times. B and the risk that the study could not be carried out if certain conditions could not be agreed with the participating organizations. For HRA-authorized studies, HRA`s initial evaluation letter (and HRA authorization letter) specifies the corresponding agreement for each type of site in a study. The document may refer to the declaration of activity and the timing of events, to a model of agreement (for example.
B mCTA) or another sponsor document. There are several types of agreements and you should use the one that best suits your type of study and sponsorship agreements. For more information, visit the IRAS website. Primary Care mCTA was designed to simplify and expedite the process of stopping and initiating pharmaceutical and biopharmaceutical clinical trials on primary care patients. The intention is that the mCTA Primary Care Centre will be used regularly without modification by all promoters of the pharmaceutical and biopharmaceutical industry of contract clinical research, where patients with NHS are recruited into primary care. In such cases, no further legal review is required, saving money and time.