In a previous video we discussed the relationship between risk management and the ISO14155. Today we’ll answer the following question:
“How is risk management integrated in the conduct of your clinical investigation?”
Whether it is related to monitoring or adverse events reporting, risk management activities should be performed continuously throughout the conduct of a clinical investigation.
The result of the risk assessment and the clinical development stage of the clinical investigation are used to create a risk-based monitoring plan and its supporting rationale. The extent and nature of this risk-based monitoring is determined by the sponsor, and can be performed in two ways:
- through centralized monitoring, where the anonymized clinical data is assessed independently of location,
- and through source data verification, where the clinical data is verified on site.
Do you want to make sure that you are properly managing all relevant data for risk-based monitoring in your clinical investigation? The In-depth ISO14155 training offers you all the information you need.