Master Clinical Study Agreement

Based on the success of the 2017 EFS project, the Efs 2018 Contract Group has for the first time developed (A) a specific EFS clinical trial agreement (MCTA) and (B) has made the EFS MCTA available to the public on MDIC`s website, both for Efs participants in the field of medical technology and for the provider of EFS services. With the commitment of a variety of stakeholders, including industry, health care providers and regulators, the objective of the publication of this MCTA is to facilitate the efficiency of the EFS process by developing an MCTA EFS that provides (1) a starting point for contract negotiations with a priority agreement of 90% or more and (2) allows both parties to focus the remaining legal resources on the remaining 10% (or less) of the MCTA EFS which require negotiations. The Early Feasibility Study Master Clinical Trial Agreement (MCTA) is available here: When researchers often collaborate with a particular sponsor of the OUHSC, ORA often suggests that the industry sponsor use previously negotiated clinical study agreements as “models” for future studies. When an industry sponsor agrees to use “models,” both parties always have the option of renegotiating each language that requires revision because of the diversity of study, change or business guidelines, etc. In many cases, the need to renegotiate conditions is quite low, resulting in a much shorter period of time for the conclusion of the clinical trial agreement. Each sponsor in the industry is unique and, ultimately, each sponsor decides whether or not to allow the use of master-templates. The use of Master Template Agreement can significantly expedite the conclusion of contract negotiations for a clinical trial. Master`s agreements generally require intensive negotiations, as their conditions must be acceptable for all clinical trials submitted to them. A master`s contract can take years to negotiate and conclude, but it is generally valid three (3) to five (5) years after signing. It is very difficult to change the terms of a master`s contract after being executed by all parties.

Master`s agreements are agreements that embody the agreed terms of a basic relationship between the university and a sponsor. The Early Feasibility Study (EFS) model was presented by the Medical Device Innovation Consortium (“MDIC”) as an educational tool. It is not designed as legal advice and should not be considered.