ClinicalTrials.gov Support
ClinicalTrials.gov is a federally mandated registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. We are here to help you comply with regulations and policies for trial registration and reporting.
Request a ClinicalTrials.gov Account
To register or access studies, include the protocol number
Login to ClinicalTrials.gov
Login with your institutional email. The organization is UColorado.
Start with our step by step Registration Instructions: Registration User Guide_CU_10-30-2019
Follow our step by step instructions for registering and maintaining your studies.
Email ClinicalResearchSupportCenter@ucdenver.edu to request a ClinicalTrials.gov account.
Not sure whether you need to register your study? Refer to our FAQ, or email us to ask!
Are you ready to report results to ClinicalTrials.gov?
The results data that need to be reported to ClinicalTrials.gov are probably simpler than you think!
Step one is to gather the data that you’ve collected for the following:
- Participant Flow – How many people started versus finished each period of your study and how many dropped out along the way.
Most studies only have one period. However, some studies (for example, crossover studies) may have more. For example: Period 1: “First Treatment for 3 Weeks”, Period 2: “Washout, 1 Week”: Period 3: “Second Treatment for 3 Weeks”. - Baseline Characteristics – Demographics data, such as age/sex/ethnicity/race of your participants, and any study-specific baseline measures (for example, “Participant a1c”) that you collected, if any.
- Outcome Measure Data – These are very basic tables of the data that you collected for each of your Outcome Measures. The table rows will be the measurement and the columns will be the arms/groups of participants. You can see sample records with
results information here.
- Adverse Events – All SAEs, and any AEs that occurred at a frequency over a certain threshold (if any).
Next, follow the PRS Guided Tutorials for Entering Results, which will take you through the process step-by-step.
If you have questions while working through the tutorials, contact ClinicalResearchSupportCenter@ucdenver.edu.
Not sure if you need to report results, or when to report results? Refer to our FAQ, or email us to ask.
ClinicalTrials.gov Tip of the Week
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Understanding the “Time Frame” field in the Adverse Events Module
Mar 4, 2021The Adverse Events Time Frame is the specific period of time over which adverse event data were collected for each study participant. It is NOT the overall duration of the study during which adverse events were being collected for all participants.Full story -
Understanding the “U.S. FDA-regulated Device?” Field in ClinicalTrials.gov
Feb 25, 2021ClinicalTrials.gov defines this field as indicating whether “a clinical study is studying a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act.”Full story -
Major Issue: “More than one outcome measure appears to be described”
Feb 18, 2021An Outcome Measure described in a ClinicalTrials.gov record should be an individual variable or measurement used to assess the protocol outcome. If an Outcome Measure includes multiple measurements or variables, PRS will reject the record with the following comment: "Major Issues: More than one outcome measure appears to be described."Full story