Table 2.
Table of procedures for TARGET-IBD activity
| Activity | Screening/enrollment visit* | Follow-up | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | |||||||||||||||||
| Month 0 | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 27 | 30 | 33 | 36 | 39 | 42 | 45 | 48 | 51 | 54 | 57 | 60 | |
| Informed consent | X | ||||||||||||||||||||
| Inclusion/exclusion | X | ||||||||||||||||||||
| Blood sample collection† | X | X | X | X | X | X | |||||||||||||||
| PRO surveys‡ | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| Medical records submission¶ | X§ | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
*Study procedures will be completed at a regularly scheduled clinic visit.
†Participants will be asked to provide an optional blood sample.
‡Participants will be asked to complete optional PRO measures every 3 months.
§Three years of redacted historical records may be submitted following the Screening/Enrollment visit.
¶During the follow-up period, redacted medical records will be submitted every 3 months for up to 5 years. The first submission during the follow-up period will be 3 months following the Screening/Enrollment visit. Additional interim medical records submissions may be requested.