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Table 3 Study sample characteristics (number, %)

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

   Total
   n %
Total studies   43 100
Study design Interventional 34 79.1
Observational 9 20.9
Study type Multicenter 10 23.3
Singlecenter 33 76.7
Study sponsor Investigator (academic) 40 93.0
Industry 3 7.0
Type of research Drug 29 67.4
Medical Device 5 11.6
Biological Samplesa 4 9.4
Otherb 5 11.6
Study phase (drug studies, n = 29) I 9 31.1
II 7 24.1
III 8 27.6
IV 3 10.3
Otherc 2 6.9
  1. Study sample including 43 studies monitored by the CTU Basel between 2012 and 2014
  2. aBiological samples incl. physiological or genetic analysis of human biological samples (e.g. urine, blood, tissue, etc.)
  3. bOther incl. observational research, health economics assessments, or tissue-based intervention/stem-cell transplantation
  4. cOther incl. cost-effectiveness trials not specific to a phase