ACRP CCRC exam| 70 QUESTIONS| ANSWERS ALL CORRECT

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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 p... rovide 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 [Show More]

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