SOCRA CCRP Certification Exam 2025 Complete Study Guide and Clinical Research Exam
Preparation Notes
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)
What is a UADE? - correct answer ✔✔Unanticipated adverse device effect (UADE) - any serious
adverse effect on health or safety, any life-threatening problem or death caused by, associated
with the device,.. not previously identified in nature, severity, or degree of incidence in the
applications; or any others if related to rights, safety, or wefare of subjects
UADE Reporting Requirements for Investigator and Sponsors - correct answer ✔✔1. Investigator
submits to Sponsor and IRB asap, but no later than 10 business days after knowledge of event
occurring.
2. Sponsor reports to all other IRBs and investigators, and FDA within 10 working days
SAE reporting requirement for drug trial - correct answer ✔✔1. Immediately for the investigator
2. 15 calendar days for the Sponsor
UADE reporting requirement for device trials - correct answer ✔✔Within 10 working/business
days for both investigator and Sponsor
Preparation Notes
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)
What is a UADE? - correct answer ✔✔Unanticipated adverse device effect (UADE) - any serious
adverse effect on health or safety, any life-threatening problem or death caused by, associated
with the device,.. not previously identified in nature, severity, or degree of incidence in the
applications; or any others if related to rights, safety, or wefare of subjects
UADE Reporting Requirements for Investigator and Sponsors - correct answer ✔✔1. Investigator
submits to Sponsor and IRB asap, but no later than 10 business days after knowledge of event
occurring.
2. Sponsor reports to all other IRBs and investigators, and FDA within 10 working days
SAE reporting requirement for drug trial - correct answer ✔✔1. Immediately for the investigator
2. 15 calendar days for the Sponsor
UADE reporting requirement for device trials - correct answer ✔✔Within 10 working/business
days for both investigator and Sponsor
