Maybe this is a qualification audit for contracting a central IRB or possibly a compliance audit if something was questionable in your study. There is too much to cover in a short response; however, you need to look at their "processes" for the systems that they are responsible for to ensure that these are adequate and performed in accordance with any regulations/SOPs. For example, what is their process when a subject calls with a complaint? What steps occur? Are the steps outlined in a formal SOP? Can they provide documented evidence to demonstrate that they are following the steps? Are the steps (i.e., process) adequate from beginning to end (closing the loop) to ensure that the complaint is resolved and the subject(s) rights and safety are protected? That's just one example. The IRBs perform an important function but sometimes lack adequate processes/procedures and sometimes do not have an accurate understanding of requirements for certain aspects (e.g., short form consenting, foreign subjects, and expedited review). If you're not experienced with the details of the IRB's regulatory requirements, how IRBs function, and/or familiar with conducting IRB audits, consider taking an experienced consultant with you. Best Regards! Laurie
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Laurie Taddonio
LMT Consulting LLC
Aliso Viejo CA
United States
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Original Message:
Sent: 19-Sep-2017 13:18
From: Anonymous Member
Subject: IRB Audit
This message was posted by a user wishing to remain anonymous
Hello: Does anyone have experience auditing IRBs? Besides the audit checklists that are out there and the FDA guidance, are there any specific items recommended to be reviewed? Please let me know.
Many thanks!