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.
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.
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