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 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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