Good clinical study contracts help ensure the sustainability of an experimental site and manage the way research is conducted on the site. The objectives of contract negotiations include budgetary issues, procedural issues, legal issues, resource limitations, content barriers and management barriers. The team of authors recognized differences between national and local laws, as well as organisational guidelines, by setting the minimum threshold of 90% for the accepted MCTA EFS. In order to ensure additional efficiency for the remaining 10% (or less) of the MCTA negotiations of the sponsor and the institution of the EFS, The team of authors recommends focusing legal resources on the following MCTA sections and/or addressing specific test points in an appropriate plant statement (SOW): 1st Section 11.5: Record Retention – The Early Feasibility Study (“EFS”) Master Clinical Trial Agreement template is provided by the Medical Device Innovation Consortium (MDIC) as a training tool. It is not designed as legal advice and should not be considered. The applicable laws may vary from state to state. Federal and regional laws for clinical trials are also subject to different changes and interpretations by courts in different jurisdictions. Each institution and sponsor that enters into a clinical study agreement should consult its own advisor for legal advice on clinical trial contracts. The terms and conditions of my service are part of this agreement. By using the Service, you accept any provision of this Agreement, whether you have read it or not. This agreement also applies to all people who use your service. A description of the authorized and prohibited use of data services is available online at www.verizonwireless.com/support/important-plan-information/. Verizon settlements and payments do not charge you for the service during the trial period.
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