The Proposed New FDA Rule Brings Changes To Informed Consent for Clinical Studies

The Diagnostic and Interventional Cardiology website posted an important article about recent proposed changes by the FDA which may allow Institutional Review Boards (IRB) to waive or alter informed consent requirements for clinical studies that pose minimal risk to human participants. The conditions under which an IRB could do this are limited and detailed in the proposed new rule.

Read The Full Article Explore TrialStat EDC – Our Unified eClinical Suite

You're Going to be Amazed By TrialStat

With TrialStat your studies will run smoothly, on-time and within budget.

Your Study Coordinators will enjoy the intuitive user interface and the speed in which they can enter their data. Schedule your personalized demo today to see first hand how TrialStat will transform your studies!

Close