ACRP CCRC exam 100% SOLUTION

ACRP CCRC exam 100% SOLUTION The _________ has developed the Declaration of Helsinki (DoH): - 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. - ANSWER the physician (DoH) In medical research, societal/scientific interest should always be prioritized after: - 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... - 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. - ANSWER Institutional Review Board/Committee (DoH) The physician should cease any investigation if: - 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)? - 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): - 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): - 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: - 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? - ANSWER side effect (ICH-E2A) Definition of Unexpected Adverse Drug reaction? - ANSWER an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator Brochure). (ICH-E2A) Definition of Serious Adverse Event: - ANSWER any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (ICH-E2A) In regards to SAEs, what does the term 'life-threatening' mean? - ANSWER an event in which the patient was at risk of death at the time of the event; (it does not refer to an event which