The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: March 6, 2019 from 10am to 11:30am
Location: Online evnt
Street: Online Event
Website or Map: https://www.traininng.com/web…
Phone: (510) 962-8903
Event Type: webinar
Organized By: Joseph Wilcox
Latest Activity: Feb 1, 2019
The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).
The Final Rule has been in effect since January 18, 2017. The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. To fulfill this obligation organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE to ClinicalTrials.gov or a WHO primary registry.