November 19, 2018
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 November 2020 to include an editable version (MS Word) of the CF template for EFS trials.
November 19, 2018
When hospital administration, research staff and IRB members have a good understanding of EFS, the time to complete study contracts, IRB approvals and patient screening and enrollment are likely to decrease. To aid with the education of these stakeholders, a brief “Background Information on Early Feasibility Studies:IRBs and Site Study Staff” has been created. This document describes points to consider when contemplating enrolling patients in early feasibility studies. It describes what an early feasibility study is and what participation means to the patient. It also discusses what types of studies and options there are under EFS and safeguards to put in place for patient protection.
Current as of October 25, 2019
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