Jul 22, 2022 | Hot Topics, Regulatory Updates
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...
Jun 22, 2021 | Regulatory Updates
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...
May 11, 2021 | Hot Topics
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...
Feb 26, 2021 | Hot Topics, Uncategorized
Institutional Review Board: Management and Function” is now available through the Jones & Bartlett Learning website. Ms. Savini, Ms. Christianson, and Ms. Matuk of HRP Consulting were honored to contribute content for this book, casually referred to as the “IRB...
Feb 15, 2021 | Team, What's New With HRP?
We’re pleased to announce that Cheryl Savini, SVP, has been appointed to the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Subcommittee on Harmonization. The Harmonization Subcommittee is charged with identifying, prioritizing, and developing...
