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.
Start with our step by step Registration Instructions and our Outcome Measures Tip Sheet.
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!
Questions about results requirements? Check out our new ClinicalTrials.gov Results Tip Sheet!
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.
ClinicalTrials.gov Tip of the Week
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Interventional vs. Observational Study Design
Sep 8, 2022In short, it comes down to whether the researcher is assigning participants to receive an intervention so that they can study how that intervention relates to a health outcome, or if they are observing health outcomes in patients who already naturally belong to a group of interest (i.e., have a certain condition, are receiving a certain treatment as part of standard of care).Full story -
Don’t forget to click the “Entry Complete” button!
Sep 1, 2022Clicking the “Complete” button tells the CU ClinicalTrials.gov administrator that your record is ready to be released to ClinicalTrials.gov’s PRS staff for QC review and publication.Full story -
Study Design: Primary Purpose Types for Interventional Studies
Aug 25, 2022If you are registering an interventional trial, you'll need to select the Primary Purpose for that trial from a pre-defined list within the Study Design module. Refer to these definitions below when selecting the Primary Purpose for your interventional study.Full story