United States of America

United States of America

ClinicalTrials.gov

Verified on September 9, 2021

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)

Interventional

(Phase 2-4)
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
ClinicalTrials.gov Registration

Yes

Within 21 days of first patient enrollment
Results

Yes

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

Registry Updates


  • September 2021: What’s New on ClinicalTrials.gov - Below update was posted on ClinicalTrials.gov What’s New section on September 16, 2021: Webinar on ClinicalTrials.gov Modernization: Join us on October 7, 2021, from 1:30 to 2:00 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts and information on the anticipated … Continue reading "September 2021: What’s New on ClinicalTrials.gov"
  • August 2021: US Regulatory Update - FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov The FDA issued a Notice of Noncompliance on August 31, 2021, to Andrey Petrikovets, M.D. (responsible party) affiliated to University Hospitals Cleveland Medical Center, for failing to submit required summary results information to ClinicalTrials.gov. The company failed to update the study results … Continue reading "August 2021: US Regulatory Update"
  • July 2021: US Regulatory Update - FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov  The FDA issued a Notice of Noncompliance on July, 26th to Accuitis, Inc. for failing to submit required summary results information to ClinicalTrials.gov. The company also failed to update the primary completion date for their applicable clinical trial (ACT) within 30 … Continue reading "July 2021: US Regulatory Update"

References


  1. ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies. ClinicalTrials.gov. https://prsinfo.clinicaltrials.gov/definitions.html. Published June 27, 2018. Accessed March 13, 2019.
  2. ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies. ClinicalTrials.gov. https://prsinfo.clinicaltrials.gov/results_definitions.html. Published June 27, 2018. Accessed March 13, 2019.
  3. Frequently Asked Questions – ClinicalTrials.gov. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/manage-recs/faq#fr_23. Published November 2018. Accessed March 13, 2019.