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. The MCTA is concluded by the sponsor and the institution (i.e. the organization of the participants), while the CRO-mCTA will be used if, in addition to these two parties, the sponsor enters into contracts with a CRO responsible for the aspects of field trial management. The role assigned to the parties continues to reflect the position of HRA and the business community, which considers the sponsor to be responsible for personal data and the organization of the participants and the CRO as a subcontractor acting on behalf of the sponsor for the purposes of the clinical trial (clauses 6.2.1 mCTA and CRO-mCTA). The model agreements are available here on the IRAS website. If a model based on the agreement model contains changes, the sponsor will explain the reasons. These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; they replace the 2011 country versions. The accompanying guidelines provide more general information, an overview of changes from the 2011 versions, and additional information on how models should be used and under what circumstances. Models, guides and information on feedback can be found in the “Models and Accompanying Materials” section on the IRAS help pages. Overall, parts entering updated MCTAs and CRO-mCTAs may feel safe and protected by the new models, which greatly improves the limited protection of previous documentation. The adoption of this more robust literature is particularly welcome in the current climate and is an important step forward in addressing the need to streamline clinical trials related to COVID-19.
This need is also reflected in the accelerated authorisation procedure for COVID-19 studies, which is now only 24 to 72 hours from about 80 days.