Variations in Administrative Approvals During the COVID-19 Pandemic at Participating Sites in the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry: A Cross-Sectional Study.
Crit Care Explor
; 4(12): e0822, 2022 Dec.
Article
in En
| MEDLINE
| ID: mdl-36567789
ABSTRACT
There is a paucity of literature regarding administrative approvals required for clinical studies during a pandemic. We aimed to evaluate variation in duration of administrative approvals within the Viral Infection and Respiratory illness Universal Study (VIRUS) A Global COVID-19 Registry. DESIGN SETTING AND SUBJECTS:
Survey analysis of 188 investigators who participated in the VIRUS COVID-19 registry, a prospective, observational global registry database of 287 sites.INTERVENTIONS:
None. MEASUREMENTS AND MAINRESULTS:
For each study site approved through December 8, 2020, we assessed the duration in days 1) from institutional review board (IRB) submission to IRB approval, 2) from IRB approval to Research Electronic Data Capture (REDCap) access, 3) from REDCap access to first patient data entry in REDCap, and 4) total duration from IRB submission to first patient data entry in REDCap. Analysis of variance and Wilcoxon rank-sum test were used to compare time durations. Of 287 sites, 188 sites (United States = 155, non-United States = 33) provided complete administrative data. There was considerable variability in duration from IRB submission to first patient data entry with median (interquartile range) of 28 days (16-50 d), with differences not significantly different by country (United States 30 [17-50] vs non-United States 23 d [8-46 d]; p = 0.08) or previous "multisite trial experience" (experienced 27 [15-51] vs not experienced 29 d [13-47 d]; p = 0.67). The U.S. sites had a higher proportion of female principal investigators (n = 77; 50%), compared with non-U.S. sites (n = 7; 21%; p = 0.002). Non-U.S. sites had a significantly shorter time to first patient data entry after REDCap access 7 (1-28) versus 3 days (1-6 d) (p = 0.02).CONCLUSIONS:
In this Society of Critical Care Medicine global VIRUS COVID-19 Registry, we identified considerable variability in time from IRB submission to first patient data entry with no significant differences by country or prior multicenter trial experience. However, there was a significant difference between US and non-U.S. sites in the time from REDCap access to first data entry.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Type of study:
Clinical_trials
/
Observational_studies
/
Prevalence_studies
Language:
En
Journal:
Crit Care Explor
Year:
2022
Type:
Article
Affiliation country:
Mongolia