Time period (month) | Activity |
---|---|
1–3 | Complete local R&D approval and set up for 4 sites |
4–6 | Initiate early recruitment (internal pilot study at 4 sites and continue R&D approval for other sites) |
7–36 | Main recruitment for trial |
37–48 | Complete final 12 month follow-up |
49–54 | Analysis and write up of main HTA monograph |
55–63 | Preparation for 5 year clinic review |
64–96 | Conduct 5 year clinic review |
64–69 | Internal pilot follow-up for 5 year review |
70–72 | Three months to follow-up the last participant to be followed-up for the internal pilot |
73–75 | If internal pilot is unsuccessful, to complete analysis and write up the report |
97–105 | Allow 9 months to complete clinics and prepare analysis |
106–108 | Complete analysis and write HTA addendum monograph |