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Ongoing Review of Studies by IRB/ECs

By Ashish Rastogi posted 04-30-2011 11:49 PM

  
Would like to know the experiences with Ongoing review of studies by EC/IRB's.

  1. How often/frequently do you know EC/IRBs to do this? 

2.   In your opinion/knowledge - do they seek only periodic progress report or do some of them sometimes arrange to visit the sites / see records for the ongoing overview?

3.  What is the system/method/perspective by which the EC/IRBs usually review the SAE reports? 

4.  Does the EC/IRB meet specifically to review the SAE report or does it take up the report for review only during the next scheduled meeting (which may be 1-2 months away)?

5.  Does EC/IRB also review the opinion of Investigator regarding causality (let us say the Investigator decides that it is unrelated: does the EC weigh the evidence based on which the investigator arrived at this opinion?)

6.  Do the EC/IRBs actively review and form an opinion based on SAE reports received from other (global or national) sites where the study is progressing (even though those sites are not under the purview of this EC)?


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Raja' Sammour
06-22-2011 03:50 AM

this should be based on the IRB SOPs. Each study has its needs for oversight. The minimum accepted is an annual review for the original approval but still it may not be sufficient. How to address review of adverse events is something that is to be decided in developing the review system. It is true that IRB have no governance on other sites but data from these sites may raise concerns about the trial conducted. As IRB we are obliged to protect so taking measures to do that properly should not be overlooked. I am not sure how much of all this is practiced but all your questions hit the spot.