|
STUDY PERIOD
|
---|
Preparation
|
Enrolment
|
Post-Surgery Phase
|
Completion
|
---|
*Timepoint
|
-t1
|
t0
|
t1
|
t2
|
t3
|
t4
|
tx
|
---|
Preparation Phase
|
REC Approval
|
X
| | | | | | |
HRA Approval
|
X
| | | | | | |
R&D Approval
|
X
| | | | | | |
Site initiation visit
|
X
| | | | | | |
Statistical plan write up
|
X
| | | | | | |
Collection proforma
|
X
| | | | | | |
Submit work to sites
|
X
| | | | | | |
Enrolment Phase
|
Eligibility screening
| |
X
| | | | | |
Informed consent
| |
X
| | | | | |
Recruitment
| |
X
| | | | | |
Baseline variables
| |
X
| | | | | |
Post-Surgery Phase
|
Outcome variables
| | |
X
|
X
| | | |
Other data variables
| | |
X
|
X
| | | |
Project Completion
|
Data analysis
| | | | | | |
X
|
Statistical write-up
| | | | | | |
X
|
Close Study
| | | | | | |
X
|
Dissemination of results
| | | | | | |
X
|
Other Milestones
|
Patient Focus Groups
| | | | |
X
|
X
| |
Reports to NIAA
| | | | |
X
| |
X
|
- *Timepoint = -t1= project preparation, t0 = baseline, t1 = 6 weeks, t2 = 12 weeks, t3 = 9–12 months, t4 = 17–20 months