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Institutional review board approval of CENTER-TBI protocol
 Figure 2. Detailed overview of primary IRB review and duration.
Figure 2 legend:
This figure provides a detailed overview of the number of primary local and central IRB review rounds and their duration in days. *The number of review rounds was only reported for the initial center of each country. **Information on the first review round was missing. ***Only the total number of days was available
Several IRBs commented on different aspects of the protocol: selection criteria (n=3, 7 38%), patient/proxy consent (n=4, 50%), and information forms (n=3, 38%). Also,
specific questions were asked on possible non-standard care factors in particular MRI
scans (N=4), blood sample collection (N=4). Four questions were asked about privacy
and data security, mainly related to the period after study completion. All relevant information can be found in the supplementary files.
Duration from protocol submission to IRB approval
The median time from protocol submission until the required IRB approval was obtained to start the study was 114 days (IQR 75-224). The fastest required IRB approval was obtained after one day in Serbia and Romania, whereas the longest time was found in a center in the UK (535 days). Obtaining central IRB approval (138 days, IQR: 91- 229) took significantly longer (p=0.0074) than obtaining local IRB approval (50 days, IQR: 29-102) (Table 2).
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