How Does ClinicalTrials.gov Fit into the Clinical Trial Disclosure Landscape?
DescriptionThis session covers the history of ClinicalTrials.gov, explains why trials should be registered and results should be reported, and describes the potential consequences of noncompliance.
To learn more about the topics in this video, visit these resources:
- Trends, Charts, and Maps (new window) : View charts and maps displaying a variety of statistics about the studies registered on ClinicalTrials.gov, including the locations of studies, types of registered studies, and number of studies registered over time. (Source: ClinicalTrials.gov)
- Clinical Trials (new window) : Read about the International Committee of Medical Journal Editors (ICMJE) policies regarding clinical trial registration and data sharing statements for journal submissions. (Source: ICMJE)
- FDAAA 801 and the Final Rule (new window) : Read a summary of the clinical trial registration and results information submission requirements described in FDAAA 801 and the Final Rule. (Source: ClinicalTrials.gov)
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (new window) : Read about the purpose of this policy, and find the effective date and contact information for inquiries about NOT-OD-16-149.
- SE1344 (new window) : Download a PDF file to read about the mandatory reporting of an 8-digit clinical trial number on Medicare claims. (Source: Centers for Medicare and Medicaid Services)
- ORD Sponsored Clinical Trials: Registration and Submission of Summary Results (new window) : Find resources for research administrators that support the registration of clinical trials sponsored by the U.S. Department of Veterans Affairs (VA) Office of Research and Development and the submission of summary results. (Source: VA)
- Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (new window) (PDF) and Frequently Asked Questions - Responsible Party (new window) : Learn more about how to determine the responsible party for a study. (Source: ClinicalTrials.gov)
- Frequently Asked Questions - Updates to Clinical Trial Information (new window) : View a list of clinical trial registration data elements that should be updated more frequently on ClinicalTrials.gov. (Source: ClinicalTrials.gov)
- Guidance Document: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020) (new window) : Find guidance for responsible parties, submitters of certain applications and submissions to the U.S. Food and Drug Administration (FDA), and FDA staff. (Source: FDA)
- Glossary of Common Site Terms (new window) : Consult a glossary to help you understand words and phrases that are frequently used on ClinicalTrials.gov. (Source: ClinicalTrials.gov)
- FDAAA TrialsTracker (new window) : Use this tracker created by the Evidence Based Medicine DataLab at the University of Oxford to see whether a clinical trial is in compliance with FDAAA 2007 regarding reporting results. (Source: FDAAA TrialsTracker)
Last Reviewed: September 10, 2021