ClinicalTrials.gov: New HHS and NIH Trial Reporting Requirements May 23, 1:00-2:00 ET
Rebecca Williams, Assistant Director of ClinicalTrials.gov, will provide an overview of the new clinical trial registration and results information submission requirements that became effective on January 18, 2017. The HHS regulations (42 CFR Part 11) clarify and expand the reporting requirements for clinical trials of FDA-regulated products as initially described in the Food and Drug Administration Amendments Act of 2007. The NIH policy is complementary to the regulations. These requirements are intended to help ensure information about ongoing and completed clinical trials are available to the public. Attendees will gain a better understanding of how these requirements apply to research being conducted at their institution and how to support researchers in understanding the information that must be submitted. Information on the resources available to support institutions and researchers will also be highlighted. Williams will additionally demo the beta version of ClinicalTrials.gov. Attendees are eligible for 1 MLA CE
Registration information is here: https://nnlm.gov/class/finalrule