• With engagement of diverse stakeholders including industry, care provider organizations, and regulators, the EFS MCTA was developed to:
    • Provide a starting point for contract negotiations with a priori agreement of 90% or greater
    • Allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation
  • This tool is intended to bring efficiencies into the clinical trial contracting process; with specific attention those trials gaining IDE approval through the EFS program within CDRH. The Negotiation Tool outlines a process for avoiding negotiation positions which are expected to be unacceptable to the other party before negotiations begin. EFS Language Libraries are intended to facilitate customizations to the Key Terms & Conditions suggested in the above proactive Negotiation Range process.
  • 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.
  • This document is directed to patient advocates and describes what it means for a patient to participate in an EFS.
  • This document focuses specifically on what it means to the patient to participate in an EFS. The Patient Introduction is an educational aid provided to the patient prior to presentation of the ICF.
  • A best practices guide for navigating Early Feasibility Study (EFS) complexities, including regulatory, ethical and legal considerations. Developed as a supplement to the FDA’s Guidance on EFS/FIH Investigational Devices, the EFS Blueprint addressed topics including FDA interactions, Ethics Committees and/or Institutional Review Boards (IRB)s, legal considerations, and patient perspectives.
  • Cardiology Research at Columbia University Irving Medical Research Center developed this screening consent form document as an alternative to a full consent process for studies in which the anatomy plays a key part in inclusion/exclusion.