Participant time line Screening Screening Trial Trial Trial Trial Trial Trial Trial Trial Trial Trial Trial Trial Data phase: phase: phase: phase: phase: phase: phase: phase: phase: phase: phase: phase: phase: phase: Collection Day -1 Day -0 Day 8 Day 15 Day 22 Day 29 Day 36 Day 43 Day Day Day Day Day Day Form 15-21 22-28 29-35 36-42 X Form 1-Screening and Registration Form X Form 2-Final Eligibility Assessment Form Form 3-Home BP and Side Effect X X X X X X Recording Forms Form 4-Trial Phase Clinic X X X X X X Assessment Form Form 5- dverse Events Form X X X X X X X X X X X X X X X X X X Form 6- Comment and other Unscheduled Visit Forms
Participant time line Data Collection Form Screening phase: Day -1 Screening phase: Day -0 Trial phase: Day Trial phase: Day Trial phase: Day 15-21 Trial phase: Day 22-28 Trial phase: Day 29-35 Trial phase: Day 36-42 Trial phase: Day 8 Trial phase: Day 15 Trial phase: Day 22 Trial phase: Day 29 Trial phase: Day 36 Trial phase: Day 43 Form 1-Screening and Registration Form X Form 2-Final Eligibility Assessment Form X Form 3-Home BP and Side Effect Recording Forms X X X X X X Form 4-Trial Phase Clinic Assessment Form X X X X X X Form 5- dverse Events Form X X X X X X X X X X X X Form 6- Comment and other Unscheduled Visit Forms X X X X X X
371219(v04-08-2016-17-45-14)-Envas-EnaDenk%20N-of-1%20Trial%20-Vn%203.0-(01.08.16).docx