FDA Guidance Emphasizes Importance of Robust Informed Consent Program

A new U.S. Food and Drug Administration (FDA) guidance hammers home the agency’s aggressive focus on proper informed consent programs that ensure patient safety, help subjects comprehend clinical trial specifics, and demonstrate data integrity. The “Use of Electronic Informed Consent—Questions and Answers” guidance for institutional review boards (IRBs), investigators, and sponsors also reminds industry […]

Jim Kremidas, ACRP Executive Director

Happy Holidays from ACRP!

With the holiday season upon us, we want to take a moment to sincerely thank you for your continued support of ACRP and our common mission to promote excellence in clinical research. Your continued support, and that of thousands of ACRP members and volunteers around the world, has allowed us to advance our mission and […]

US Capitol

Potential Trump FDA Chair Pick Looms Over 21st Century Cures Act

By their very nature, presidential transitions tend to be tumultuous affairs, especially when one party is taking the reins from another. That’s never been truer than this time around, with President-elect Donald Trump espousing his belief that many federal institutions are in need of serious overhaul—or outright elimination. His nominations for Health and Human Services, […]