This webinar series reviews new requirements related to ClinicalTrials.gov designed to increase the availability of registration and summary results information, including adverse event information, for specific clinical trials of drug, biologic, and device products. The requirements, referred to as the Final Rule, were developed by the Department of Health and Human Services (DHHS) and the NIH and are effective as of January 18, 2017; compliance is expected by April 18, 2017.
Webinar 1: Overview of the Final Rule (~60 minutes)
Summarizes key provisions of the final rule, with a focus on the effective and compliance dates, applicability of the final rule, and new requirements for the submission of results information for applicable clinical trials of unapproved, unlicensed, or uncleared drug, biological, and device products.
Webinar 2: Final Rule Clinical Trial Registration Information Requirements (~60 minutes)
Summarizes who must submit "expanded" clinical trial registration information, when such information must be submitted, what constitutes registration information, and when the information must be updated.
Webinar 3: Final Rule Results Information Requirements (~60 minutes)
Summarizes who must submit "expanded" clinical trial results information, when such information must be submitted, what constitutes results information, and when the information must be updated. Additionally, discusses the clinical trial information posting provisions, quality control review procedures, and when the obligation to update and correct clinical trial information ends.