Accelerate EFS Toolkit
Overview
MDIC’s work within the EFS program includes tracking EFS performance metrics, and developing tools and best practices for EFS sponsors and clinical researchers alike. In combination, these efforts are anticipated to drive overall EFS efficiency and support continuous assessment of EFS efficiency and effectiveness for US patients.
EFS Clinical Trial Agreement (CTA)
The EFS CTA was developed with input from a range of stakeholders—including industry, care provider organizations, and regulators—to streamline contract negotiations. With a prior agreement on 90% or more of the terms, both parties can focus their legal resources on negotiating the remaining 10% (or less) of the contract.
EFS Video Series
Patient ICF Template
As part of the 2016 Blueprint for Early Feasibility Study Success, a patient Informed Consent Form (ICF) template was developed for adults considering participation in a study under an IDE through the FDA’s EFS Program. The template has been updated as of November 2020, and both the revised ICF template and an editable MS Word version for EFS trials are available here.
Supporting Tools
This tool simplifies contracting for clinical trials, focusing on trials that have received IDE approval through the EFS program within CDRH. The Negotiation Tool sets up a process to prevent proposing negotiation positions likely to be rejected by the other party before discussions begin. The EFS Language Libraries facilitate customization of the recommended Key Terms and Conditions in the proactive Negotiation Range process.
This document is directed to patient advocates and describes what it means for a patient to participate in an EFS.
The “Introduction to Consent for Early Feasibility Studies for Patients” document addresses patient questions and needs. It explains what it means to participate in an EFS and emphasizes the importance of patient understanding. It is an educational aid provided before presenting the Informed Consent Form (ICF), which details the EFS, associated risks, and trial specifics.
A best practices guide for navigating 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 where anatomy plays a key part in inclusion/exclusion. This allows their team to send standard-of-care images and data to sponsors to determine eligibility before we conduct a full consent process with the patients.