Safety and Compliance Flashcards

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

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

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

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?

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

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

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

Answer: Within 7 calendar days

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

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

Answer: 15 calendar days

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

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

Answer: A mild headache that resolves within hours

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

Under the Common Rule, who is responsible for ensuring unanticipated problems are promptly reported to the IRB, institutional officials, and the department or agency head?

Answer: The institution, through written procedures

45 CFR 46.108(a)(4) requires the institution to have written procedures for prompt reporting of unanticipated problems.

A known side effect listed in the consent form and investigator brochure occurs at its expected frequency and severity. How is this typically handled?

Answer: It is an adverse event but generally not an unanticipated problem

Expected events occurring at anticipated frequency and severity do not meet the 'unexpected' criterion for an unanticipated problem.