Table 4.
Informed consent violations
| On-site |
No on-site |
|||||
|---|---|---|---|---|---|---|
| Identified through |
Identified through |
|||||
| Local review, Pts (%) | On-site visit, Pts (%) | Either | Local review, Pts (%) | On-site visit, Pts (%) | Either | |
| Any informed consent violation | 33 (1.6) | 24 (1.1) | 56 (2.7) | 40 (1.8) | 1 (0.04) | 41 (1.8) |
| Type of consent violation founda | ||||||
| - Prior to randomization, participant signed an incorrect or unapproved main study consent form | 0 (0.0) | 13 (0.6) | 13 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| - Baseline stored specimens were collected prior the participant signing the IRB/EC-approved main study consent form | 5 (0.2) | 3 (0.1) | 8 (0.4) | 17 (0.8) | 0 (0.0) | 17 (0.8) |
| - The signature page of the most recently signed mains study consent form is not on file | 28 (1.3) | 10 (0.5) | 38 (1.8) | 28 (1.2) | 1 (0.04) | 29 (1.3) |
| - The signature on the most recently signed main study consent form was not made by the participant or legal representative | 2 (0.1) | 0 (0.0) | 2 (0.1) | 3 (0.1) | 0 (0.0) | 3 (0.1) |
a
Participants could have more than one type of violation for this monitoring outcome
IRB = Institutional review board
EC = Ethics committee