May 10, 2022

The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources.

Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an EFS-specific Master Clinical Trial Agreement (MCTA), and (B) make that EFS MCTA publicly available on the MDIC website for both medical technology and care provider EFS participants. With engagement of diverse stakeholders including industry, care provider organizations, and regulators, the goal of releasing this MCTA is to facilitate efficiencies in the EFS contracting process by developing an EFS MCTA providing (1) a starting point for contract negotiations with a priori agreement of 90% or greater, and (2) allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation. The Early Feasibility Study Master Clinical Trial Agreement can be found here.

A template of a patient Informed Consent Form (ICF) for adult patients considering participation in a study being conducted under an IDE through the FDA’s EFS Program was developed as part of the 2016 Blueprint for Early Feasibility Study Success. Updated for 2022, the ICF throughly outlines how those conducting studies can explain the process of participating in a study, the benefits of contributing to research as participant of early feasibility studies, the risks associated with participation and the patients rights to potential participants. Click here to see the full template.