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Posted On: 05/07/2025 7:44:17 AM
Post# of 152747
They both looking on a different things mostly , The way protocols are done IRB changing protocol approved by FDA very rarely ..
IRB is worry more about safety how actual trials are conducted , if enough of checkups and follow ups etc .
As FDA looking at safety of drug itself...
They really evaluating a different things.. When FDA approve the protocol , for IRB to want to change something from FDA is rare , and require big documentation....
IRB is worry more about safety how actual trials are conducted , if enough of checkups and follow ups etc .
As FDA looking at safety of drug itself...
They really evaluating a different things.. When FDA approve the protocol , for IRB to want to change something from FDA is rare , and require big documentation....
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