SOCRA CCRP Certification Exam 2026/2027
| Comprehensive Study Guide & Practice
Test
Nuremburg Code - correct answer-The first set of principles outlining professional
ethics for clinical research.
Nuremburg Code elements - correct 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 - correct answer-Nuremberg Code first (1947).
Declaration of Helsinki second (1964). Belmont Report third (1979).
Belmont Report Principles and Application - correct 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 - correct answer-6th-8th
grade
8 Basic Elements of informed Consent - correct 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 - correct 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 - correct 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 - correct 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 - correct 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? - correct 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
5. unanticipated adverse device effect (UADE)
| Comprehensive Study Guide & Practice
Test
Nuremburg Code - correct answer-The first set of principles outlining professional
ethics for clinical research.
Nuremburg Code elements - correct 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 - correct answer-Nuremberg Code first (1947).
Declaration of Helsinki second (1964). Belmont Report third (1979).
Belmont Report Principles and Application - correct 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 - correct answer-6th-8th
grade
8 Basic Elements of informed Consent - correct 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 - correct 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 - correct 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 - correct 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 - correct 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? - correct 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
5. unanticipated adverse device effect (UADE)
