General instructions

This Risk-Based Monitoring (RBM) Score Calculator was developed by the Monitoring Platform of the Swiss Clinical Trial Organisation (SCTO).
These user instructions enable you to calculate and determine the recommended monitoring strategy for a particular clinical trial you are planning. On the tabs on the left, you will be presented with a variety of topics.
Several risks are listed in each topic. For each risk, you should indicate the:
  • Impact of the risk on the participants’ safety and rights, data integrity, or Good Clinical Practice (GCP) compliance
  • Occurrence with which the risk might happen
  • Detectability of the risk by the monitor
For each risk, a score of 1–3 is considered low, 4–9 as medium, and 10–27 as high.
Once all risks are entered, the RBM Score Calculator provides you with an overall answer on the trial risk calculated based on the frequency of high, medium and low risks, as depicted below.
Note:
  • Details on the Swiss categorisation (A, B, C) can be found in the Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices ( ClinO ) and in the Ordinance on Clinical Trials with Medical Devices ( ClinO-MD ).
  • For medical devices, the sub-categories A1, A2, C1, C2 and C3 are not further distinguished. Please refer to the main categories A and C to determine the monitoring strategy.
As an example, consider a trial with very complicated inclusion criteria. The potential impact of having such complicated inclusion criteria is high on the participants' safety and on data integrity because it increases the risk of including participants that are not eligible for participation. Depending on the number of the complicated inclusion criteria, it might happen more or less often. Detecting wrongly included participants might also be difficult, and in this case, the detectability will not be high. In addition, notes justifying the choice can be added.
Warning: please only enter alphanumeric characters in the notes, and avoid special characters (≥, +, umlauts, accents, …)


Once you have completed the information related to each risk, the RBM Score Calculator summarizes the results on the Report tab. At the bottom of the page you will also find a button to download a report. This report will contain all risk factors considered for the trial and all notes justifying your choice.
Your user feedback is welcome to help us to improve our calculator.

General Study Information

Note: For medical devices, the sub-categories A1, A2, C1, C2 and C3 are not further distinguished. Please refer to the main categories A and C to determine the monitoring strategy.

I. Participant

For each of the following risk factors, indicate whether it is applicable, and if so, it's impact, occurrence and detectability.

II. Design

For each of the following risk factors, indicate whether it is applicable, and if so, it's impact, occurrence and detectability.

III. Safety

For each of the following risk factors, indicate whether it is applicable, and if so, it's impact, occurrence and detectability.

IV. Intervention (IMP, IMD, surgery, etc.)

For each of the following risk factors, indicate whether it is applicable, and if so, it's impact, occurrence and detectability.

V. Management

For each of the following risk factors, indicate whether it is applicable, and if so, it's impact, occurrence and detectability.

VI. Data

For each of the following risk factors, indicate whether it is applicable, and if so, it's impact, occurrence and detectability.

VII. Other

Enter other more trial specific risks here

Overview of the data entered

Risk summary

Risk matrix

The outlined box indicates the recommended Risk Based Monitoring strategy for your trial, based on the information you have entered.
Download a PDF report of your results by clicking the 'Generate report' button below
Generate report