ACRP CCRC exam| 70 QUESTIONS|
ANSWERS ALL CORRECT
The _________ has developed the Declaration of Helsinki (DoH): Correct Answer: World
Medical Association; as a statement of ethical principles to provide guidance to p
...
ACRP CCRC exam| 70 QUESTIONS|
ANSWERS ALL CORRECT
The _________ has developed the Declaration of Helsinki (DoH): Correct Answer: World
Medical Association; as a statement of ethical principles to provide guidance to physicians and
other participats in medical research involving human subjects.
(DoH) It is the duty of ________________ in medical research to protect the life, health, privacy
and dignity of the human subject. Correct Answer: the physician
(DoH) In medical research, societal/scientific interest should always be prioritized after: Correct
Answer: prioritization of the subject's health and well being
(DoH) The primary purpose of medical research involving human subjects is to: 2 part answer...
Correct Answer: 1) improve prophylactic, diagnostic and therapeutic procedures
2) improve the understanding of the aetiology and pathogenesis of disease
(DoH) The _________________________________ must be independent of the investigator, the
sponsor or any other kind of undue influence. Correct Answer: Institutional Review
Board/Committee
(DoH) The physician should cease any investigation if: Correct Answer: the risks are found to
outweigh the potential benefits.
(DoH) What is obtained in the place of 'consent' when the subject is deemed legally incompetent
(such as a child)? Correct Answer: 1) obtain the subject's assent
2) obtain the subject's legally authorized representative's consent
(ICH-E2A) Definition of Adverse Event (or Adverse Experience)(AE): Correct Answer: any
untoward medical occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have to have a causal relationship with
this treatment .
(ICH-E2A) Definition of Adverse Drug Reaction (ADR): Correct Answer: all noxious and
unintended responses to a medicinal product related to any dose should be considered adverse
drug reactions.
(ICH-E2A) Examples of Adverse Events: Correct Answer: abnormal laboratory finding,
symptom or disease; "any unfavorable and unintended sign"
(ICH-E2A) What term is NOT synonymous with adverse event and should no longer be used?
Correct Answer: side effect
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