TAG ARCHIVES FOR FDA regulations

31
Aug2017

In July, PRIM&R collaborated with CITI Program to host the advanced-level webinar Data and Safety Monitoring: Advanced Issues and Case Studies. Expanding on introductory knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program’s Biomedical Basic course, this webinar described ways in which the IRB, the data and safety monitoring board (DSMB), the investigator, and the sponsor can work together to ensure scientific integrity and subject safety in clinical trials. Summaries of government and non-government organizations’ guidance as well as interactive case studies offered strategies for handling complex situations that may arise during data and safety monitoring, including when and how to report adverse and unanticipated events, when a DSMB is needed, and what is considered a conflict of interest. Read more

10
Feb2017

This week’s Research Ethics Roundup covers President Trump’s call for removing a majority of FDA regulations, the argument for calling for efficacy data before human research begins, USDA’s decision to remove Animal Welfare Act records, and FDA’s case for conducting phase three testing. Read more