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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

  1. 1–3 conducted according to the Swiss Clinical Trial Organization Guidelines for Good Operational Practice V2.0. Scheme adapted from Hurley et al. [23]. aIncluding indicators on vulnerability of study population, setting of recruitment, critical eligibility criteria, additional risks of therapy, trial procedures that are unusually complex, etc. bIncluding essential technical, personnel, storage, transport, or documentation requirements at site. Site-related indicators do not affect the risk category of a study, but may modulate the extent and duration of individual monitoring visits. Human Research Act (HRA), ADApted MONitoring (ADAMON), Clinical Trials Ordinance (ClinO)