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!

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:

  1. 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”. 

  2. 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.

  3. 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. 

  4. 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

  • What if I Need to Report Results, but my Outcome Measures Have Changed?

    Oct 14, 2021
    In general, your goals will be: 1) To report all Outcome Measures that are listed as Primary or Secondary Outcome Measures in the protocol, and 2) To explain any discrepancies between the initial registration and current Primary and Secondary Outcome Measures, to avoid the appearance of reporting bias.
    Full story

  • Should I Register my Observational Study?

    Oct 7, 2021
    Observational studies do not meet the FDA, NIH, or ICMJE definitions of clinical trials, and are not required by these organizations to be registered on ClinicalTrials.gov, but should you register anyway? There are a few reasons you might want to consider registering an observational study.
    Full story

  • The Sponsors and Collaborators Module

    Sep 30, 2021
    The Sponsors and Collaborators module is part of the Protocol section of your ClinicalTrials.gov record. There are two required fields and one optional one. Here is how to fill them out for CU records.
    Full story
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