SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 15 Topic 2 Discussion
CCRP Exam Topic 2 Question 15 Discussion:
Question #: 15
Topic #: 2
If a subject experiences a serious adverse event related to the study drug and only minimal information is available, the investigator must submit the information to the:
A.
IRB/IEC immediately, then sponsor when full details are available
B.
Sponsor and IRB/IEC immediately, then update later
ICH E6(R2) 4.11.1:Investigators must “immediately report all serious adverse events to the sponsor except for those the protocol identifies as not requiring immediate reporting.”
IRB must also be informed promptly per21 CFR 312.64(b).
Follow-up information is submitted later as available.
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