The United States of America (USA) clinical trials registry, ClinicalTrials.gov, is considered as a global platform for registering the clinical trials. It is not a World Health Organization (WHO) recognized primary registry. However, the clinical trials registered on this registry fulfill the criteria for publication of manuscript in an International Committee of Medical Journal Editors (ICMJE) accredited journal. In the USA, registration of protocols and submission of results is governed by the NIH Final Rule (42 CFR Part 11), which has been in effect since January 18, 2017. This regulation requires registration and results reporting for phase 2-4 interventional clinical trials.
|Registries at a Glance|
|Registry||PHUSE Categorization||Information to be Entered By||Route of Data in Registry||Study Type||Language|
|ClinicalTrials.gov||Country requiring/recommending ClinicalTrials.gov use||Sponsor||Through a dedicated registration platform (process independent from clinical trial application)||
|Registration and Results Requirements|
|Within 21 days of first patient enrollment|
|Primary Results - within one year of primary completion date (PCD); Subsequent Results - within one year of the last subject last visit for each secondary outcome measure (SOM); Final Results - within one year of the study completion date|
- December 2021: What’s New on ClinicalTrials.gov - On December 22, 2021, ClinicalTrials.gov updated the materials for Modernization and Beta Website webinar: A recording of the December 10, 2021 webinar and slides describing the launch of beta ClinicalTrials.gov and demonstration have been added to the ClinicalTrials.gov Modernization page. This webinar provides an update on the modernization effort and a demonstration of the beta ClinicalTrials.gov website.
- December 2021: What’s New on ClinicalTrials.gov - ClinicalTrials.gov Beta Website On December 08, 2021, ClinicalTrials.gov posted an update announcing the first release of the beta ClinicalTrials.gov website and it can be accessed at: ClinicalTrials.gov beta website. More information on the new features that the website provides can be found at: NLM Technical Bulletin. Also, PRS Beta will be released to the PRS … Continue reading "December 2021: What’s New on ClinicalTrials.gov"
- December 2021: What’s New on ClinicalTrials.gov - Webinar on ClinicalTrials.gov Modernization and Beta Website Demonstration On December 02, 2021, ClinicalTrials.gov posted an update about the Webinar on ClinicalTrials.gov Modernization and Beta Website Demonstration. The webinar would be held on December 10, 2021, from 1.00 to 1.45 pm Eastern Time. The webinar would provide an update on the modernization effort and a demonstration … Continue reading "December 2021: What’s New on ClinicalTrials.gov"