Table 2 Reasons why survey responders did or did not conduct a risk assessment prior to developing the monitoring plan
Participants who did conduct a risk assessment (n = 50) | % | Participants who did not conduct a risk assessment (n = 35) | % |
|---|---|---|---|
Facilitators | Barriers | ||
To improve patient safety | 43 (86%) | Question not relevant, developing monitoring plan is a sponsor duty | 15 (43%) |
To improve data accuracy | 32 (64%) | It is not a GCP requirement | 7 (20%) |
To fulfil GCP requirements | 29 (58%) | Do not have the expertise to perform a risk assessment | 6 (17%) |
To determine a schedule for on-site monitoring visits | 21 (42%) | It is too time consuming | 6 (17%) |
To fulfil HPRA/IMB requirements | 20 (40%) | It will not improve patient safety | 2 (6%) |
To reduce monitoring costs | 8 (16%) | It is too expensive | 1 (3%) |