Preparing to Report ResultsJan 7, 2021
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 – This is 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, but if you’re doing something like a crossover study, you may have more (e.g. Period 1: “First Treatment for 3 Weeks”, Period 2: “Washout, 1 Week”: Period 3: “Second Treatment for 3 Weeks”).
- Baseline Characteristics – Demographics data, like age/sex/ethnicity/race of your participants, and any study-specific baseline measures (e.g. “Participant a1c”, etc.) 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, where 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. Contact email@example.com if you get stuck or have questions.Where required, results must be submitted to ClinicalTrials.gov within 12 months of the Primary Completion Date (the last study visit when you collected data for your primary outcome measure).
Tags: 42CFR11 adverse events baseline characteristics clinicaltrials.gov FDAAA801 outcome measures participant flow requirements results