Table 2 Timeline of clinical trial visits and assessments
Timepoint | ||||||
|---|---|---|---|---|---|---|
Assessment | Screening | Visit 1 | Visit 2 | Phone call | Visit 3 | Follow-up visit |
Day-7 to 28 | Day 0 | Day 55 ± 7 | Day 112 ± 7 | Day 182 ± 7 | Day 196 ± 7 | |
Informed consent | x | |||||
Demographics/Medical history | x | |||||
Concominant medications | x | x | x | x | x | x |
Abbreviated physical exam | x | x | x | |||
Vital signs | x | x | x | x | ||
Spirametry | x | x | ||||
Clinical laboratory assessments | x | x | ||||
Blood collection for CF genotype | x | |||||
Blood collection for HLA typing | x | |||||
Blood for banking (immune monitoring) | x | x | ||||
Adverse event assessments | x | x | x | x | x | |
Medication and diary drug | x | |||||
Review study drug count and diary | x | x | ||||