ACRP- Clinical Research Knowledge Assessment (CRKA)

ACRP- Clinical Research Knowledge Assessment (CRKA) True or false? Direct communication between a sponsor and IRB/IEC is expressly prohibited per GCP. - Correct Answers False As part of their risk assessment process the sponsor determines that there is a high likelihood that enrollment in the trial will be challenging and slow. Which of the following is the best choice in this situation: a. The sponsor should develop a risk management plan to handle this operational risk b. The sponsor should develop a proactive recruitment strategy to mitigate the risk of low enrollment c. The sponsor should outsource the trial to a CRO to ensure enrollment success d. All of the above e. A and B only - Correct Answers e. A and B only In considering whether or not to approve a clinical trial, the IRB/IEC should consider the qualifications of the investigator via review of a current curriculum vitae or other documentation. a. True b. False c. It depends - only if the IRB/IEC hasn't worked with the investigator in the past - Correct Answers a. True Which of the following documents has/have influenced the ethical principles within the current GCP guidelines? a. The Nuremberg Code b. The Declaration of Helsinki c. The Paris Report d. A and B - Correct Answers d. A and B All of the following are elements or principles of human subject protection EXCEPT a. Voluntary, informed consent b. Respect for persons: treated as autonomous agents c. The right to end participation in research at any time d. Right to safeguard integrity e. Benefits should outweigh risk f. Protection from physical, mental, and emotional harm g. The primary care physician can overrule the subject's decision to participate in a trial h. Access to information regarding research i. Protection of privacy and well-being - Correct Answers g. The primary care physician can overrule the subject's decision to participate in a trial True or False? One benefit of transparent reporting of trial results is that it enables the reader to judge the reliability and validity of trial results. - Correct Answers True True or False? One important distinction between standard of care medical treatment and clinical r