Topics in Human Subjects Research

NIH Clinical Trials Designation - Implications for Social Science Research

a Presentation

Wednesday, 10/10/2018, 1:00pm.   ARCHIVED EVENT

Location: 1430 ISR-Thompson 

Topics that will be covered include:

• How to determine if your project meets the NIH definition of a clinical trial
• Special NIH requirements for clinical trials
• Tips on registration on www.ClinicalTrials.gov and results reporting
• Single IRB-of-Record requirements
• Helpful resources (institutional and national)

Beginning in 2015, NIH began issuing a series of policies designed to strengthen the stewardship of clinical trials funded by the agency. These policies are intended to "enhance the accountability and transparency of clinical research." Several ISR studies have already registered as clinical trials under these new policies.
This session, presented by Cindy Shindledecker, Director of the IRB-HSBS, and Kate Sasamoto, Research Compliance Associate, Office of Research Compliance Review, will cover NIH requirements for research meeting the NIH clinical trial definition, especially as they pertain to social science research. A question and answer period will follow. 

If you have questions please contact Barbara Ward at barbward@umich.edu.  

If you require accommodations to attend this presentation please contact Anna Massey at abeattie@umich.edu at least one week prior to the event.

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