A physician wants to conduct research using an approved/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. In this case, the physician must obtain which of the following?
A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard.
Before applying this change to all subjects, what must occur?
An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?
Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?
Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?
