HSR Safety and Compliance 2

Question 1

Under OHRP guidance, which combination of features defines an unanticipated problem involving risks to subjects or others?

Accepted Answer

Unexpected, related or possibly related to the research, and suggests greater risk of harm than previously recognized

Answer

OHRP defines an unanticipated problem by three criteria: unexpected, related or possibly related, and indicating greater risk of harm.

Question 2

A research laptop containing unencrypted identifiable survey data on illegal drug use is stolen. No one was physically harmed. How should this generally be classified?

Accepted Answer

An unanticipated problem because it places subjects at greater risk of social or legal harm

Answer

Unanticipated problems include non-physical harms such as breaches of confidentiality that increase social, legal, or psychological risk.

Question 3

Under FDA IND safety reporting rules, how quickly must a sponsor report an unexpected fatal or life-threatening suspected adverse reaction to FDA?

Accepted Answer

Within 7 calendar days

Answer

21 CFR 312.32 requires unexpected fatal or life-threatening suspected adverse reactions to be reported no later than 7 calendar days.

Question 4

Under FDA IND regulations, a serious and unexpected suspected adverse reaction that is NOT fatal or life-threatening must be reported to FDA within:

Accepted Answer

15 calendar days

Answer

Other serious unexpected suspected adverse reactions must be reported in an IND safety report within 15 calendar days.

Question 5

Which outcome would NOT by itself qualify an adverse event as 'serious' under FDA's definition?

Accepted Answer

A mild headache that resolves within hours

Answer

Serious adverse events include death, life-threatening events, hospitalization, significant disability, and birth defects, not transient mild symptoms.

HSR - Human Subjects Research Certification Practice Test

HSR - Human Subjects Research Certification Practice Test

HSR Safety and Compliance 2