CRC LSS - NOV09

"Demystifying ClinicalTrials.gov - Clinical Trials Registration"

ClinicalTrials.gov is a registry of clinical trials operated by the National Library of Medicine that captures key summary protocol information before/during the trial and summary results of a completed trial. The rationale is to ensure that information about the existence and design of a clinical trial is publicly available and increase the transparency of research.

Registration is required for the following trials:
All Phase II - IV drug, biologic, and device trials regulated by FDA
All clinical trials planning to publish in one of the International Committee of Medical Journal Editors (ICMJE) journals

This presentation will provide a comprehensive review of ClinicalTrials.gov. The presentation will focus on topics such as: who needs to register, when to register, what and how to post on the ClinicalTrials.gov registry, and FDA form 3674. Additionally, adverse event posting, required as of September 27, 2009, will be addressed.

Time will be available for questions regarding new requirements and any other concerns relating to clinical trials registration.

Speaker:
Sarah White, Assistant Director, Partners Human Research Quality Improvement Program

Course location:
Simches 3.110

Session Info

• November 09, 2009 (12:00 PM - 01:00 PM) - Clinical Trials Registration: Demystifying ClinicalTrials.gov

Facility Information

Demystifying ClinicalTrials.gov: Clinical Trials Registration (S. White)
Directions