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