Can a CRO employee, holding the key position, be a member of the IRB?
CHP -Not if the CRO does studies reviewed or judicated by the IRB in question. This is a “conflict of Interest”. It is, indeed, strange for a CRO employee to also work for an IRB/IEC. If you know someone in this position, it is my thinking that you know someone with an ego and a power problem. 3. GCP guidelines says that it’s also sponsors responsibility to monitor the study but FDA auditors/Inspectors believes that it could lead to bias or manipulation if Sponsors monitor is present during dosing or conduct of study. Please comment on this. CHP – True, the sponsor “monitors” studies but this is to insure that the protocol is followed. I have not heard of an FDA inspector making a statement suggesting that a sponsor’s monitor could lead to bias. Since when would a PI (of any worth) follow anything but the protocol. How could they unless the PI and study staff are incompetent. Actually, the sponsors ‘monitors’ are rarely (if never) present at the time a study is being conducted. Before,
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- Can a CRO employee, holding the key position, be a member of the IRB?
