Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation

[silentmonkey]

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?

 

[indubioush]

It is acceptable to have a benefit-risk analysis be a standalone document.

 

[Raisin picker]

Well, if you have a change in the risk analysis that affects the RBA, this also requires to address that change in the clinical evaluation, and vice versa. The two processes should be closely linked.

 

[FoGia]

I would say that the risk benefit analysis should logically within the CER as it is one of its primary purposes (per MDR). It's also the document that captures up to date data on state of the art/alternatives/clinical background and a bunch of other information that aren't typically described in the RMR.
You could have the analysis be a stand alone document but as mentioned above it would need to be updated together with the CER anyway.