SOCRA CERTIFICATION 2026 TEST
BANK PRACTICE SOLUTION SET
◉ Nuremburg Code elements.
Answer: 1. Voluntary informed consent
2. research benefits society
3. should be based on prior animal work
4. avoid suffering and injury
5. research where death and disabling injury is expected shouldn't be
conducted
6. risks should be justified
7. proper preparations and adequate facilities
8. conducted by scientifically qualified
9. subjects can withdraw
10. research must end the study if there is probable cause that continuing
would lead to injury, disability, or death.
◉ Timeline of Historical Events.
Answer: Nuremberg Code first (1947). Declaration of Helsinki second
(1964). Belmont Report third (1979).
◉ Belmont Report Principles and Application.
Answer: There are 3:
,1. Respect for persons = informed consent
2. Beneficence = risk/benefit analysis
3. Justice = appropriate selection of patients
◉ Language Level Recommended for Informed Consent.
Answer: 6th-8th grade
◉ 8 Basic Elements of informed Consent.
Answer: 1. statement explaining the study involves research.
2. description of risks or discomforts.
3. description of benefits.
4. alternative treatments/procedures.
5. confidentiality.
6. compensation for involvement and/or injury.
7. who to contact.
8. voluntary and can discontinue
◉ Additional Elements of Informed Consent.
Answer: 1. unforeseeable risks to subject.
2. participation can be terminated by investigator.
3. any additional costs.
4. consequences of the subject's decision to withdraw
5. significant new findings will be shared
, 6. approx # of subjects in the study.
◉ Differences between short and long informed consent form.
Answer: Long = the standard consent form.
Short = document states that the elements have been presented orally to
and understood by the subject or LAR.
◉ ICF Monitoring Considerations.
Answer: 1. subject has signed most recent IRB approved version
2. subject signature is present in addition to subject name
3. subject date themself and date is correct
4. any errors corrected w/single line thru error
5. all pages of ICF are present
◉ SAE Reporting Requirements for Investigator and Sponsor.
Answer: 1. Investigator immediately reports to Sponsor
2. Sponsor reports to FDA and all investigators participating no later
than 15 calendar days if it qualifies as reportable.
◉ What is a reportable SAE to the FDA?.
Answer: 1. Serious and unexpected
2. findings from other studies suggest significant risk
3. Findings from animal or in-vitro testing
4. increased rate of occurrence of SAEs
BANK PRACTICE SOLUTION SET
◉ Nuremburg Code elements.
Answer: 1. Voluntary informed consent
2. research benefits society
3. should be based on prior animal work
4. avoid suffering and injury
5. research where death and disabling injury is expected shouldn't be
conducted
6. risks should be justified
7. proper preparations and adequate facilities
8. conducted by scientifically qualified
9. subjects can withdraw
10. research must end the study if there is probable cause that continuing
would lead to injury, disability, or death.
◉ Timeline of Historical Events.
Answer: Nuremberg Code first (1947). Declaration of Helsinki second
(1964). Belmont Report third (1979).
◉ Belmont Report Principles and Application.
Answer: There are 3:
,1. Respect for persons = informed consent
2. Beneficence = risk/benefit analysis
3. Justice = appropriate selection of patients
◉ Language Level Recommended for Informed Consent.
Answer: 6th-8th grade
◉ 8 Basic Elements of informed Consent.
Answer: 1. statement explaining the study involves research.
2. description of risks or discomforts.
3. description of benefits.
4. alternative treatments/procedures.
5. confidentiality.
6. compensation for involvement and/or injury.
7. who to contact.
8. voluntary and can discontinue
◉ Additional Elements of Informed Consent.
Answer: 1. unforeseeable risks to subject.
2. participation can be terminated by investigator.
3. any additional costs.
4. consequences of the subject's decision to withdraw
5. significant new findings will be shared
, 6. approx # of subjects in the study.
◉ Differences between short and long informed consent form.
Answer: Long = the standard consent form.
Short = document states that the elements have been presented orally to
and understood by the subject or LAR.
◉ ICF Monitoring Considerations.
Answer: 1. subject has signed most recent IRB approved version
2. subject signature is present in addition to subject name
3. subject date themself and date is correct
4. any errors corrected w/single line thru error
5. all pages of ICF are present
◉ SAE Reporting Requirements for Investigator and Sponsor.
Answer: 1. Investigator immediately reports to Sponsor
2. Sponsor reports to FDA and all investigators participating no later
than 15 calendar days if it qualifies as reportable.
◉ What is a reportable SAE to the FDA?.
Answer: 1. Serious and unexpected
2. findings from other studies suggest significant risk
3. Findings from animal or in-vitro testing
4. increased rate of occurrence of SAEs
