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Table 4 Study sample by risk categories and associated risk factors

From: Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

   Total
   n %
Total studies   43 100
ADAMON risk category Low 11 25.6
medium 23 53.5
High 9 20.9
Total 43 100
Electronic database present at first patient in Yes 19 44.2
No 24 55.8
Total 43 100
Principal Investigator change during study Yes 3 7.0
No 40 93.0
Total 43 100
Vulnerable study populationa Yes 7 16.3
No 36 83.7
Total 43 100
Total sites   94 100
Staff experiencedb, by site Yes 88 93.6
No 6 6.4
Total 94 100
Staff change, by site Yes 11 11.7
No 48 51.1
Unknown 35 37.2
Total 94 100
  1. Study sample including 43 studies monitored by the CTU Basel between 2012 and 2014, stratified by ADAMON risk categories, and factors associated with risk evaluation
  2. aDefined as “children, adolescents, adults lacking capacity in the consent procedure, pregnant women and in-vitro fertilized embryos and fetuses, prisoners, and subjects in emergency situations” (according to HRA, Chapter 3)
  3. bDefined as a) GCP trained, b) solely dedicated to research activities (e.g. a study nurse, resident, etc.), and c) has been involved in the conduct of one or more clinical research studies before