| | Duration (days)a | Centers (N) | Missing (N) |
|---|
All centers | 114 (75–224) | 58 | 8 |
Local review | 50 (29–102) | 10 | 4 |
Central review | 138 (91–229)b | 48 | 4 |
- Central (1) | 98 (94–114) | 16 | 0 |
- Central (2) | 189 (140–270) | 17 | 3 |
- Central (3) | 104 (62–224) | 15 | 1 |
- Local review: Obtained primary local IRB approvals only applied to the associated research centers and allowed study start without any additional requirements
- Central (1): Primary central IRB approval with national impact, applying to all center within a country, without the need for additional local IRB review
- Central (2): Primary central IRB approval only allowed study start in the research centers associated with the approving IRB. Other participating centers required approval after additional extensive local IRB review
- Central (3): Primary central IRB approval only allowed study start in the research centers associated with the approving IRB. Other participating centers required approval after additional marginal local IRB review
- aDuration was reported in median number of days (IQR)
- bGroup differences between local and central review were significant (P = 0.0074, Mann-Whitney U)
