Table 2 Duration of the administrative process associated with industry-sponsored clinical trial activation at the USF’s Office of Clinical Research (OCR)
From: Activating clinical trials: a process improvement approach
Sub-process | Number | Duration in calendar days | |
|---|---|---|---|
Average (Median, SD) | IQR (Q1, Q3) | ||
Initial Preparation | - | 11a | - |
Contract Negotiation | 69 | 54.9 (33, 50.3) | 58 (19,77) |
Budget Negotiation | 40 | 46.3 (40, 34.6) | 54 (14, 68) |
PI Approval | 78 | 4.8 (4, 4.7) | 6 (1, 7) |
DSR Approval | 78 | 5.5 (3, 6.2) | 9 (0, 9) |
Sponsor Approval | 78 | 5.5 (3, 6.2) | 9 (0, 9) |
Entire Process | 78 | 76.6 (69, 41.1) | 58 (46, 101) |