Reporting Results on ClinicalTrials.gov

Questions? Contact Clinical Trials Regulatory Support

Overview

Requirements and resources for reporting study results on ClincalTrials.gov.

Requirements for Reporting Results

Results are required to be reported within one year of the Primary Completion Date external site (opens in a new window) for:

For more details on results reporting for ACTs, see FDAAA 801 and the Final Rule: When Do I Need to Submit Results external site (opens in a new window) .

For more details on results reporting for NIH-funded clinical trials, see the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information external site (opens in a new window) .

Potential Regulatory Consequences of Failing to Report Timely Results

Assistance with Reporting Results

Review the ClinicalTrials.gov Results Reporting Guided Tutorial external site (opens in a new window) and the Results Quality Control Review Criteria external site (opens in a new window) .

PRS provides Example Studies for Results Data Entry external site (opens in a new window) .

For expert help on data analysis, interpretation of results, and other biostatistical issues, request a Biostatistics Consultation external site (opens in a new window) from CTSI Consultation Services.

Contact CT.gov@ucsf.edu external site (opens in a new window) for ClinicalTrials.gov help at UCSF, including Results Reporting assistance.

Contact ClinicalTrials.gov PRS at register@clinicaltrials.gov external site (opens in a new window) .