Exploratory: Include only if applicable, or delete Duration of Individual Provide the estimated duration of time (days, weeks, or months) Subject Participation: for a subject to complete their participation in the study. Estimated Time to Last Provide the proposed timeframe from study activation to the last Subject/Last Study Day: subject’s last study day (defined as the time point the final subject will be contacted by the study site), as described in the protocol. The schematic should provide an overview of the study design. Examples are provided: Example #1: Table format (e.g., dose escalation) Table : Treatment Arms ARM 1 Sample Size Intervention 1 Cohort A ARM 2 Sample Size Intervention 2 Instructions for progressing to next phase (include only if applicable, or delete): ARM 1 Sample Size Intervention 1 Cohort B ARM 2 Sample Size Intervention 2 Example #2: Flow diagram Figure : Schematic of Study Design
Exploratory: Include only if applicable, or delete Duration of Individual Subject Participation: Provide the estimated duration of time (days, weeks, or months) for a subject to complete their participation in the study. Estimated Time to Last Subject/Last Study Day: Provide the proposed timeframe from study activation to the last subject’s last study day (defined as the time point the final subject will be contacted by the study site), as described in the protocol. The schematic should provide an overview of the study design. Examples are provided: Example #1: Table format (e.g., dose escalation) Table : Treatment Arms Cohort A ARM 1 Sample Size Intervention 1 ARM 2 Sample Size Intervention 2 Instructions for progressing to next phase (include only if applicable, or delete): Cohort B ARM 1 Sample Size Intervention 1 ARM 2 Sample Size Intervention 2 Example #2: Flow diagram Figure : Schematic of Study Design