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?”
Transcript:
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.
