Clinical Research Organisation Model Clinical Trial Agreement (February 2018)

Nationally approved standard location agreements help speed up the contracting process of industry-sponsored studies carried out in the NHS by creating the need for site-by-site verifications and local legal agreements. This enables an earlier start-up, improves the speed of industry-sponsored clinical trials and allows NHS patients to access innovative treatments faster. The series of model location agreements is supported by guidelines that set out the objectives and will detail how the agreement should be used in the development of clinical research contracts sponsored by pharmaceutical, biopharmaceutical or medical companies. 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 more general information, an overview of changes from the 2011 versions, and other information on how the models should be used and under what circumstances. The team of authors acknowledged the differences between national and local laws as well as organizational policies when setting the minimum threshold of 90% for acceptance of the aforementioned EFS MCTA. In order to support the remaining 10% (or less) of the MCTA negotiations on EFS sponsors and institutions, the team of authors recommends that legal resources be focused on the following mcta sections and/or that specific points be addressed in a corresponding specification (SOW): 1. Section 11.5: Record Retention The model Clinical Trials Agreement for Biopharmaceutical Industry Sponsored Primary Care Research (Primary Care mCTA) has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of highly 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. 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. There is a risk of not taking care of it from the point of view of obtaining studies. We simply cannot compete internationally, which is necessary to ensure that we can attract education. Ensure the sustainability of clinical trials in Canada.

If anyone sees a potential risk, contact the CCLC and we would be happy to discuss it. Building on the success of the EFS 2017 project, the EFS Contracts Working Group decided for the first time in 2018 to develop (A) an EFS-specific Master Clinical Trial Agreement (MCTA) and to make (B) this EFS MCTA publicly available on the MDIC website, both for medical technology participants and for the EFS service provider. With the participation of different stakeholders, including in the industrial field, sub-service organisations and regulatory authorities, the objective of unlocking this MCTA is to facilitate the efficiency of the EFS contract process by developing a EUROPEAN SOCIAL SECURITY SYSTEM which (1) constitutes a starting point for contractual negotiations with an A priori agreement of 90% or more and (2) allows both parties to set up the legal resources remaining on the remaining 10% (odes) (r minus) of the EFS MCTA that require negotiations. . . . .