SOCRA CERTIFICATION EVALUATION
QUESTIONS AND CORRECT ANSWERS
PRACTICE PACK
●● "What ethical principle focuses on minimizing harm and maximizing
benefit?"
Answer: "Beneficence (Belmont Report)"
●● "Which Belmont principle relates to autonomy and informed
consent?"
Answer: "Respect for Persons"
●● "Which ethical principle ensures fair subject selection?"
Answer: "Justice (Belmont Report)"
●● "Which document emphasizes physician responsibility and IRB
review?"
Answer: "Declaration of Helsinki"
●● "What does 21 CFR Part 50 govern?"
Answer: "Informed consent requirements"
,●● "What does 21 CFR Part 56 govern?"
Answer: "IRB composition, duties, and review requirements"
●● "What is the Common Rule?"
Answer: "45 CFR Part 46 - protection of human subjects"
●● "Which regulation governs drug and biologic studies?"
Answer: "21 CFR Part 312 (IND)"
●● "Which regulation governs device studies?"
Answer: "21 CFR Part 812 (IDE)"
●● "What does 21 CFR Part 11 address?"
Answer: "Electronic records and electronic signatures"
●● "What is the main philosophy of ICH GCP E6 (R3)?"
Answer: "Quality by design and risk-based approaches"
●● "What should oversight focus on according to E6 (R3)?"
Answer: "Critical data and critical processes"
●● "What does proportionality mean in ICH GCP E6 (R3)?"
, Answer: "Oversight based on risk, not one-size-fits-all"
●● "When is an activity considered human subjects research?"
Answer: "Interaction or intervention with individuals OR identifiable
private information"
●● "Who determines whether research is exempt?"
Answer: "IRB (not the investigator)"
●● "Which IRB review is required for greater-than-minimal risk
studies?"
Answer: "Full board review"
●● "When is expedited review allowed?"
Answer: "Minimal risk studies that meet regulatory categories"
●● "What triggers re-consent?"
Answer: "New risk information or protocol changes affecting subjects"
●● "Name three required elements of informed consent"
Answer: "Purpose, risks, benefits, alternatives, voluntariness, contacts"
●● "What is a protocol deviation?"
QUESTIONS AND CORRECT ANSWERS
PRACTICE PACK
●● "What ethical principle focuses on minimizing harm and maximizing
benefit?"
Answer: "Beneficence (Belmont Report)"
●● "Which Belmont principle relates to autonomy and informed
consent?"
Answer: "Respect for Persons"
●● "Which ethical principle ensures fair subject selection?"
Answer: "Justice (Belmont Report)"
●● "Which document emphasizes physician responsibility and IRB
review?"
Answer: "Declaration of Helsinki"
●● "What does 21 CFR Part 50 govern?"
Answer: "Informed consent requirements"
,●● "What does 21 CFR Part 56 govern?"
Answer: "IRB composition, duties, and review requirements"
●● "What is the Common Rule?"
Answer: "45 CFR Part 46 - protection of human subjects"
●● "Which regulation governs drug and biologic studies?"
Answer: "21 CFR Part 312 (IND)"
●● "Which regulation governs device studies?"
Answer: "21 CFR Part 812 (IDE)"
●● "What does 21 CFR Part 11 address?"
Answer: "Electronic records and electronic signatures"
●● "What is the main philosophy of ICH GCP E6 (R3)?"
Answer: "Quality by design and risk-based approaches"
●● "What should oversight focus on according to E6 (R3)?"
Answer: "Critical data and critical processes"
●● "What does proportionality mean in ICH GCP E6 (R3)?"
, Answer: "Oversight based on risk, not one-size-fits-all"
●● "When is an activity considered human subjects research?"
Answer: "Interaction or intervention with individuals OR identifiable
private information"
●● "Who determines whether research is exempt?"
Answer: "IRB (not the investigator)"
●● "Which IRB review is required for greater-than-minimal risk
studies?"
Answer: "Full board review"
●● "When is expedited review allowed?"
Answer: "Minimal risk studies that meet regulatory categories"
●● "What triggers re-consent?"
Answer: "New risk information or protocol changes affecting subjects"
●● "Name three required elements of informed consent"
Answer: "Purpose, risks, benefits, alternatives, voluntariness, contacts"
●● "What is a protocol deviation?"
