Study Timeline
- FPS date is an important date in your timelines when the first patient is screened in your trial. Meaning they come in for the first visit in the SOE, but they are not given the study IP.
- Some patients are screened in a clinical trial but are not enrolled in the study. Depending on the inclusion / exclusion criteria and certain assessments such as physical exams, blood draws, etc., some patients may fail at screening meaning they cannot join the trial.
- A typical dermatology trial screen fail rate is 20%-30% meaning that you need 20%-30% more subjects to be screened in a clinical trial because the assumption is that 20% to 30% will fail at the screening visit.
- Screening visit criteria depends on the synopsis and SOE.