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

Table 4 Study sample by risk categories and associated risk factors

		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 population^a	Yes	7	16.3
	No	36	83.7
	Total	43	100
Total sites		94	100
Staff experienced^b, 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

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
^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)
^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

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