EFS Master Clinical Trial Agreement (MCTA) Template
- 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
- Early Feasibility Study Master Clinical Trial Agreement (MCTA) can be found here: EFS Master Clinical Trial Agreement (MCTA) Resource Library
Contract Language Library & Negotiation Tool
- 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.
- The Contract Language Library & Negotiation Tool can be found here: Contract Language Library & Negotiation Tool
Informed Consent Form (ICF) Template
- 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.
- An updated (JUN-2018) ICF template and editable version (MS Word) of that ICF template for EFS trials can be found here: EFS Patient Informed Consent Form Template
Background Information for IRB and Staff
- This document is directed to patient advocates and describes what it means for a patient to participate in an EFS.
- The Background Information for IRB and Staff can be found here: Background Information for Early Feasibility Studies
Background Information for Patients
- 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.
- The Background Information for Patients can be found here: Patient Introduction to Consent for EFS
Blueprint for Early Feasibility Study Success
- 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.
- The Blueprint for Early Feasibility Study Success may be found here: MDIC EFS Blueprint for EFS Success
Screening Consent Form: Informed Consent and HIPAA Authorization
- 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.
- To see how the Screening Consent Form can be used in your Early Feasibility study, visit the: Screening Consent Form: Informed Consent and HIPAA Authorization