ACRP CCRC exam 2023/2024 Correctly Answered To Pass!!!

ACRP CCRC exam 2023/2024 Correctly Answered To Pass!!! 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 hospitalization. Nausea with vomiting does not appear in the Investigator's Brochure. The investigator should rate this event as: - Answer A. expected and serious. B. expected and not serious. C. unexpected and serious. D. unexpected and not serious. (C) Which of the following documents are required to be present in the investigator's trial files at the end of the trial? - Answer 1. subject enrollment logs 2. IP certificate of analysis 3. sample of labels affixed to IP containers 4. investigator notification of new IP safety information A. 1 and 3 only B. 1 and 4 only C. 2 and 3 only D. 2 and 4 only (B) A clinical trial is being conducted to determine the safety and tolerability of a new anti-emetic IP. The sponsor expects to enroll 20 subjects. This would be considered a: - Answer A. Phase I trial. B. Phase II trial. C. Phase III trial. D. Phase IV trial (A) A subject has a history of dermatitis. During visit 2 of the trial, the subject complained of a rash. The investigator interrupted the use of the IP and the rash disappeared. At the next visit, the IP was restarted. One day later, the rash reappeared. The investigator discontinued the subject from the trial. The causality can be determined as probably related to the IP based on: - Answer A. the placebo effect. B. a positive rechallenge. C. insufficient information. D. the history of dermatitis. (B) From the sponsor's initial receipt of information about an SAE that is serious, unexpected, considered related to the use of the drug but did not result in death and was not considered life-threatening, how long does the sponsor have to notify the regulatory authorities? - Answer A. within 24 hours