Table 2 Enablers and barriers related to the conduct of a risk assessment for informing a monitoring plan
From: Research monitoring practices in critical care research: a survey of current state and attitudes
Enablers for those who conduct a risk assessment N = 33 | Barriers for those who do not always conduct a risk assessment N = 17 | ||
|---|---|---|---|
Enabler | n (%) | Barrier | n (%) |
To improve patient safety | 29 (88) | Do not have the expertise to perform a risk assessment | 10 (59) |
To improve data accuracy | 29 (88) | It is too time consuming | 5 (29) |
To fulfil GCP requirements | 24 (73) | Other | 4 (24) |
To improve efficiency and objectivity of monitoring | 20 (61) | It is not a requirement of the Sponsor | 4 (24) |
To determine a schedule for onsite monitoring visits | 12 (36) | Not sure | 4 (24) |
To fulfil Sponsor requirements | 10 (30) | It is too expensive | 2 (12) |
To reduce monitoring costs | 10 (30) | It is not a GCP requirement | 0 |
Other | 0 | It will not improve patient safety | 0 |
Not sure | 0 | It will not improve efficiency or objectivity of monitoring | 0 |