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Table 2 Duration of protocol submission until required IRB approval before study start

From: How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

 Duration (days)aCenters (N)Missing (N)
All centers114 (75–224)588
Local review50 (29–102)104
Central review138 (91–229)b484
- Central (1)98 (94–114)160
- Central (2)189 (140–270)173
- Central (3)104 (62–224)151
  1. Local review: Obtained primary local IRB approvals only applied to the associated research centers and allowed study start without any additional requirements
  2. Central (1): Primary central IRB approval with national impact, applying to all center within a country, without the need for additional local IRB review
  3. 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
  4. 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
  5. aDuration was reported in median number of days (IQR)
  6. bGroup differences between local and central review were significant (P = 0.0074, Mann-Whitney U)