Hi All,
I am wondering how others have implemented the requirement for Benefit/Risk Analysis between the risk management process and the clinical evaluation process.
For risk management, I understand that an overall benefit/risk analysis is required and currently, my organisation documents this in the Risk Management Report.
As part of our clinical evaluation process, a benefit/risk analysis is also documented in the Clinical Evaluation Report.
Currently, we use the exact same wording for the benefit/risk analysis in both reports. This makes some things logistically inefficient like not being able to update one report without updating the other. Both reports require approval from a different group of cross-functional SMEs so the turnaround time for both reports is conflated.
It could be possible to remove the Benefit/Risk Analysis from one of these reports and replace it with a reference to the actual Benefit/Risk Analysis maintained in the other report but this invites other issues related to the review/approval of the BRA.
How are others currently managing this? Is it acceptable for the BRA in the Risk Management Report and the CER to be equivalent in its wording?
I am wondering how others have implemented the requirement for Benefit/Risk Analysis between the risk management process and the clinical evaluation process.
For risk management, I understand that an overall benefit/risk analysis is required and currently, my organisation documents this in the Risk Management Report.
As part of our clinical evaluation process, a benefit/risk analysis is also documented in the Clinical Evaluation Report.
Currently, we use the exact same wording for the benefit/risk analysis in both reports. This makes some things logistically inefficient like not being able to update one report without updating the other. Both reports require approval from a different group of cross-functional SMEs so the turnaround time for both reports is conflated.
It could be possible to remove the Benefit/Risk Analysis from one of these reports and replace it with a reference to the actual Benefit/Risk Analysis maintained in the other report but this invites other issues related to the review/approval of the BRA.
How are others currently managing this? Is it acceptable for the BRA in the Risk Management Report and the CER to be equivalent in its wording?