Understanding the “Time Frame” field in the Adverse Events Module
Results Reporting ModulesMar 4, 2021
When entering results for a ClinicalTrials.gov record, the first field you will encounter in the Adverse Events module is the Adverse Events Time Frame.
The 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.
Example: “Study A” tracks Adverse Events for each participant from their baseline visit at week 0 through their final study visit at week 8. The study began enrolling on March 1, 2019 and the last subject had their last study visit on March 1, 2021. The adverse events time frame for this study would be “8 Weeks”, NOT “2 Years”.
For help entering your Adverse Events into ClinicalTrials.gov, visit the Adverse Events section of the PRS Guided Tutorials for Entering Results, or contact email@example.com.