A sponsor is required by 21 CFR 312.32 to submit a...

SOCRA CCRP — Certified Clinical Research Professional

Question Number 5

A sponsor is required by 21 CFR 312.32 to submit an IND safety report to the FDA and all participating investigators for which type of event?

Any Serious Adverse Event (SAE) that occurs at any study site, regardless of causality. A suspected adverse reaction that is both serious and unexpected. Any adverse event that leads to a participant's withdrawal from the study. Only for adverse events that are both fatal and definitively related to the investigational drug.

✔ Correct Answer:

A suspected adverse reaction that is both serious and unexpected.

SOCRA CCRP — Certified Clinical Research Professional

Question Number 5

Count Down:

Related questions :