Table 1 SPIRIT recruitment schedule
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 | |||||