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 hypothetically might have caused death if it were more severe) (ICH-E2A) Regarding SAEs, differentiate the difference between the terms 'serious' and 'severe': - ANSWER Serious: seriousness is determined by the outcome (think of the definition of SAE) Severity: used to describe the intensity of a specific event (as in mild, moderate, or severe myocardial infarction) Example: a headache can be severe, but is not 'serious' until it results in either death, hospitalization/prolonged hospitalization, birth defect, significant disability. (ICH-E2A) What documents should be used to determine whether an adverse event is expected or unexpected? - ANSWER 1) Investigator's Brochure 2) Reports which add significant information on specificity or severity of a known, already documented serious ADR constitute unexpected events Example: an acute renal failure as a labeled ADR with a subsequent new report of interstitial nephritis. According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for fatal or life-threatening unexpected ADR's (adverse drug reaction)? - ANSWER ≤ 7 calendar days. "As soon as possible, but no later than 7 calendar days after first knowledge by the sponsor." According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for fatal or life-threatening unexpected ADR FOLLOW UP REPORT? - ANSWER Within 8 additional calendar days. Follow-up must include an assessment of the importance and implication of the findings, including relevant previous experience with the same or similar medicinal products. According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for all other serious, unexpected ADR's? - ANSWER ≤ 15 calendar days. "As soon as possible, but no later than 15 calendar days after first knowledge by the sponsor." A subject in a Phase I oncology trial experiences nausea with vomiting after IP infusion which results in an inpatient hospita