The _________ has developed the Declaration of Helsinki (DoH): correct answers World Medical Association; as a statement of ethical principles to provide
... [Show More] 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 answers the physician
(DoH) In medical research, societal/scientific interest should always be prioritized after: correct answers 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 answers 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 answers Institutional Review Board/Committee
(DoH) The physician should cease any investigation if: correct answers 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 answers 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 answers 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 answers 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 answers 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 answers side effect
(ICH-E2A) Definition of Unexpected Adverse Drug reaction? correct answers an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator Brochure). [Show Less]