Risk management according ISO14971
How is the risk management of a clinical study implemented? During the planning and before conducting a clinical performance study, the sponsor or his designee must conduct and document an assessment of the risks. This includes risks associated with participating in and associated with the conduction of the study. A systematic approach according to ISO14971 is implemented in parallel with the planning phase of the clinical study. It is recommended that clinical staff and PIs are involved in the risk analysis. They may identify risks that emerge in the daily routine in the clinic. In the continuous risk management process, the hazards and hazardous situations are identified. Next, the corresponding risks are analyzed and evaluated. Finallty, these risks are mitigated, and the effectiveness of the risk control measures is monitored throughout study conduction.
The aim of the process is to reduce/eliminate risks and perform a risk-benefit analysis to investigate and appropriately demonstrate the justifiability/non-justifiability of the clinical study. The risk analysis is further used to identify the reasonably foreseeable misuse and is also a basis for identifying expected adverse effects of the product.
This risk-benefit analysis must be also provided during submission to the EC/NCA.
