SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADESOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE
socra ccrp exam 2023 2024 actual exam 200 question
socra ccrp exam 2023 2024 actual exam 200
socra ccrp exam 2023 2024 actual exam
socra ccrp exam 2023 2024 actual
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SOCRA CCRP
SOCRA CCRP
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SOCRA CCRP EXAM 2023 -2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AG RADE When is a short form ICF needed? - ANSWER - For subjects whose first language is not English What are the 10 points of the Nuremberg Code? - ANSWER - - Required voluntary, informed consent - Experiment aims at positive results for society - Based on previous knowledge that justifies the experiment - Study design avoids unnecessary physical and mental suffering and injuries - Not conducted if there is any reason to believe it implies a risk of death or disabling injury - Risks < Benefits - Preparations and facilities must be provided to protect subjects against risks - Staff must be fully trained and qualified - Subject must be free to quit at any time - Medical staff stop the experiment at any time if they observe continuation would be dange rous. When can an investigational product be used without a signed consent? - ANSWER - - in a life threatening situation - inability to communicate - time is not sufficient - no alternate approved method available that provides an equal or greater likeliho od of saving the subject's life When can wards participate in a study? - ANSWER - - research related to ward status - conducted in an environment with majority of children are not wards - advocate has best interest of child during research - advocate must not be associated with guardian organization, clinical investigation, or the investigator How long must a Suspected Unexpected Serious Adverse Reaction (SUSAR) be reported to the IRB? - ANSWER - </= 15 days How long must an unanticipated a dverse device effect (UADE) be reported to the IRB? - ANSWER - </= 10 working days How long must an unexpected fatal/life -threatening AE be reported to the IRB? - ANSWER - <7 days How long do investigators need to keep current FDFs for? - ANSWER - Before st udy initiation, during the study, and 1 year after study completion What is a significant equity interest amount? - ANSWER - > $50,000 What is considered a significant payment made from the sponsor to the investigator? - ANSWER - > $25,000 What is the mai n purpose of the IRB? - ANSWER - Assure protection of rights, safety, and welfare of human subjects. Who provides the final approval of a study? a. Sponsor b. FDA c. IRB - ANSWER - c. IRB IRB must find when approving a study: - ANSWER - - risks are minimiz ed - risks are reasonable for the anticipated benefits - selection of subjects is equitable - ICF follows guidelines - ICF documented appropriately - Adequate provisions for monitoring data collected to ensure the safety of subjects - privacy and confident iality is protected - additional safeguards in place to protect vulnerable populations - copies of research proposals reviewed - minutes of IRB meetings - records of continuing reviews - copies of correspondence between IRB and investigator - list of IRB members - written procedures for the IRB - statement of significant findings provided to subjects - ANSWER - What is documented at IRB meetings? What are significant risk devices? - ANSW ER- - implants with potential serious risks - used to support or sustain human life - substantial importance in diagnosing, curing, or treating disease What kind of investigational devices are exempt from Premarket approval requirements? (IDE) - ANSWER - - diagnostic devices that are non-invasive - for vet or lab use - custom device not intended for commercial distribution - distrubuted prior to May 1976 Who must be part of the IRB members? - ANSWER - - males and females - varied background - at least 5 mem bers - 1 scientific background
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