Table 1 Risk classification procedure at Clinical Trial Unit Basel
From: Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned
Risk classification procedure | Recommended systematic review of trial’s risk profile | |||
|---|---|---|---|---|
1. Initial Risk classification | 2. Categories of risk modulators | 3. Risk classification | 4. Modulators of monitoring extent | |
Potential risk of therapeutic intervention in comparison to standard of medical care (as described in HRA & ADAMON): • Comparable (see also ClinO art. 19,20,61, category A) • Higher (see also ClinO art. 19,61, category B) • Markedly Higher (see also ClinO art. 19,20, category C) | Modulators from the following ADAMON categories may influence the initial risk category by a max. of +1 or −1 risk category (e.g. Intermediate to High Risk): 1. Potential trial participant-related critical indicatorsa 2. Robustness related indicators – “hard primary endpoints” and/or simple clinical trial procedure 3. Site-related indicatorsb | An overall risk category is assigned based on the results of 1) and 2) as follows: • Low risk: Risk of intervention comparable & trial has at least one indicator of robustness and no participant related indicator • Intermediate risk: Risk of intervention comparable, or higher & trial has no indicator of robustness, or at least one participant-related indicator present • High risk: Risk of intervention higher or markedly higher, and trial has no indicator of robustness, or at least one participant related critical indicator present | The following modulators may influence monitoring extent (i.e. number of hours per visit) within risk category: 1. site experience with clinical trials 2. presence of an electronic database at site 3. whether site is coordinating lead site of the study | An additional risk assessment is required if the trial undergoes substantial amendments |