Navigating the Expanding Regulations of ClinicalTrials.gov Registration and Results Reporting
Tuesday, April 24
Presentation: 12:00-1:00pm ET
Q&A: 1:00-1:15pm ET
US researchers have been required to register with clinicaltrials.gov and report results for over a decade, and in 2016 regulators issued clarifications on applicability of the requirement. But, as recent news reports and analyses have shown, compliance is still inconsistent. Investigators and study teams need to be aware of the requirements of several governing bodies (such as the FDA, NIH, ICMJE, WHO, CMS, and more) in order to ensure that studies are being accurately registered and reported.
In this webinar, Anthony Keyes, Program Manager at the Johns Hopkins University School of Medicine ClinicalTrials.gov Program, reviews the federal regulations regarding registration and results reporting of clinical trials. He will also provide suggestions to help researchers comply with this requirement.
In this free webinar, we will:
- Describe the background and applicable regulations regarding clinical trial registration and results reporting
- Explain the "who, what, where, when, why and how" of study registration and results reporting
- Outline tips and tricks for accurate and timely record creation and maintenance
- Principal investigators and study team members who are currently conducting or planning to conduct any clinical, interventional or behavioral research.
- This includes investigator-initiated studies and studies funded in part or in whole by NIH, CMS or foundations now requiring registration and/or results reporting.
Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.