SOCRA CCRP ACTUAL EXAM END OF
COURSE STUDY GUIDE LATEST UPDATED
ACTUAL TESTED QUESTIONS AND
CORRECT ANSWERS
⩥ The Nuremberg Code - 10 points.
Answer: 1. voluntary
2. necessary for results
3. logical design and results
4. avoid unnecessary harm
5. cannot result in death or disablement
6. risk assessment
7. protect subjects against harm
8. qualified investigators
9. right to withdrawal
10. right to end trial if needed
⩥ Belmont Report (1979).
Answer: Three core principles are identified: respect for persons,
beneficence, and justice.
,Arose in response to Tuskegee Syphilis Study - studying untreated
syphilis on African-American men unaware of their true condition and tx
plan.
⩥ Belmont Report - definitions of core.
Answer: 1. Respect for persons: informed consent + no deception
2. Beneficence: maximize benefits and minimize risk
3: Justice: fair procedures considering risk analysis.
⩥ Belmont Report - current role.
Answer: Serves as a historical document and provides the moral
framework for understanding regulations in the United States on the use
of humans in experimental methods.
⩥ Belmont Report - review of 7 items for research trials.
Answer: 1. IRB approved
2. Obtain informed consent
3. Ensure understanding
4. No coercion
5. Monitor adverse events
6. Maintain privacy
7. Ensure patients receive minimal care for their condition
,⩥ Declaration of Helsinki (1964, 1975).
Answer: Set of ethical principles regarding human experimentation
developed for the medical community by the World Medical Association
(WMA)
⩥ Good Clinical Practice (GCP).
Answer: ICH-GCP and ISO-GCP (medical device) enforces guidelines
on ethical aspects of a clinical trial.
Covers human rights, standards on trial conduct, roles and
responsibilities (IRB, PI, sponsor, monitors).
⩥ GCP v Declaration of Helinski.
Answer: GCP lacks moral principles and guidance surrounding COI,
study design, benefits, result reporting.
Also restricts placebo in control group v effective alternative tx
⩥ Common Rule.
Answer: US federal policy that specifies ethics regulations for human
subjects research
1. ICF in reasonable language, reasons why they would not want to
participate in research
, 2. Disclosure of use of de-identified data / specimens for future studies,
commercial profit, clinically relevant results disclosed, genome
sequencing
3. Consent waiver only if research could not be carried out without
accessing / using information / specimens in an identifiable format. Pre-
screening for trial permitted if able to obtain oral or written
communication OR access records / stored biospecimens.
4. Exempt / Limited IRB if
- record review both retrospectively AND propectively
- benign behavioral interactions
- collect identifiable sensitive data via adults in surveys/interviews
5. Continuing review - not required if expedited level
6. Multi-instituitional research studies required to use 1 IRB (effective
01-19-2020)
⩥ Title 21 US Code of Federal Regulations (11, 50, 56, 312, 812).
Answer: Title 21 is part of the code of federal regulations governing
good and drugs for the FDA, DEA, and ONDCP (office of national drug
control policy)
COURSE STUDY GUIDE LATEST UPDATED
ACTUAL TESTED QUESTIONS AND
CORRECT ANSWERS
⩥ The Nuremberg Code - 10 points.
Answer: 1. voluntary
2. necessary for results
3. logical design and results
4. avoid unnecessary harm
5. cannot result in death or disablement
6. risk assessment
7. protect subjects against harm
8. qualified investigators
9. right to withdrawal
10. right to end trial if needed
⩥ Belmont Report (1979).
Answer: Three core principles are identified: respect for persons,
beneficence, and justice.
,Arose in response to Tuskegee Syphilis Study - studying untreated
syphilis on African-American men unaware of their true condition and tx
plan.
⩥ Belmont Report - definitions of core.
Answer: 1. Respect for persons: informed consent + no deception
2. Beneficence: maximize benefits and minimize risk
3: Justice: fair procedures considering risk analysis.
⩥ Belmont Report - current role.
Answer: Serves as a historical document and provides the moral
framework for understanding regulations in the United States on the use
of humans in experimental methods.
⩥ Belmont Report - review of 7 items for research trials.
Answer: 1. IRB approved
2. Obtain informed consent
3. Ensure understanding
4. No coercion
5. Monitor adverse events
6. Maintain privacy
7. Ensure patients receive minimal care for their condition
,⩥ Declaration of Helsinki (1964, 1975).
Answer: Set of ethical principles regarding human experimentation
developed for the medical community by the World Medical Association
(WMA)
⩥ Good Clinical Practice (GCP).
Answer: ICH-GCP and ISO-GCP (medical device) enforces guidelines
on ethical aspects of a clinical trial.
Covers human rights, standards on trial conduct, roles and
responsibilities (IRB, PI, sponsor, monitors).
⩥ GCP v Declaration of Helinski.
Answer: GCP lacks moral principles and guidance surrounding COI,
study design, benefits, result reporting.
Also restricts placebo in control group v effective alternative tx
⩥ Common Rule.
Answer: US federal policy that specifies ethics regulations for human
subjects research
1. ICF in reasonable language, reasons why they would not want to
participate in research
, 2. Disclosure of use of de-identified data / specimens for future studies,
commercial profit, clinically relevant results disclosed, genome
sequencing
3. Consent waiver only if research could not be carried out without
accessing / using information / specimens in an identifiable format. Pre-
screening for trial permitted if able to obtain oral or written
communication OR access records / stored biospecimens.
4. Exempt / Limited IRB if
- record review both retrospectively AND propectively
- benign behavioral interactions
- collect identifiable sensitive data via adults in surveys/interviews
5. Continuing review - not required if expedited level
6. Multi-instituitional research studies required to use 1 IRB (effective
01-19-2020)
⩥ Title 21 US Code of Federal Regulations (11, 50, 56, 312, 812).
Answer: Title 21 is part of the code of federal regulations governing
good and drugs for the FDA, DEA, and ONDCP (office of national drug
control policy)
