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
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.
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
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 hereOverview 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 belowGenerate report