FDA Releases New Guidance Document on Revised Common Rule



The Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” specifies the requirements for the protection of human subjects in U.S. Department of Health and Human Services (HHS) sponsored clinical trials. A final rule published to the Federal Register in January 2017 revised the Common Rule, which has a compliance date of January 21, 2019.

FDA Announced Draft Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank



Currently, the “responsible party” must register and provide results of any applicable clinical trial in the ClinicalTrials.gov data bank under the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which added the provision to the Public Health Service Act. Submitting false or misleading information, failing to register, or failing to provide results for applicable clinical trials is prohibited by an FDAAA amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also, FDAAA amended 303(f)(3) of the FD&C Act to allow for assessment of civil money penalties for responsible parties who violated these provisions. This is relevant for drug, device, and biologic products.

Sandra “SAM” Sather Speaking at MCC Summit Nov. 14-15


Join with subject matter experts and learn what really matters in clinical trial performance metrics in the first ever Metrics Champion Consortium (MCC) Summit. Our own Sandra “SAM” Sather will present the topics critical thinking and root cause analysis. Understand if your staff has adequate critical thinking skills to evaluate risk and take appropriate action. Identify effective performance management using Gilbert’s Behavioral Engineering Model (BEM) in Clinical Research. Discover answers to key questions while delving into case scenarios with speakers and other attendees during the interactive session.