SOCRA CCRP Certification Exam With
Complete Solutions
Nuremburg Code - ANSWER -The first set of principles outlining professional ethics for
clinical research.
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
5. unanticipated adverse device effect (UADE)
What is a UADE? - 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 - 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 - ANSWER -1. Immediately for the investigator
2. 15 calendar days for the Sponsor
UADE reporting requirement for device trials - ANSWER -Within 10 working/business
days for both investigator and Sponsor
Consent and Assent Requirements for research involving children - ANSWER -1.
Parental consent from one or both parents or LAR is required
2. Child assent may be required as determined by the overseeing IRB.
Complete Solutions
Nuremburg Code - ANSWER -The first set of principles outlining professional ethics for
clinical research.
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
5. unanticipated adverse device effect (UADE)
What is a UADE? - 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 - 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 - ANSWER -1. Immediately for the investigator
2. 15 calendar days for the Sponsor
UADE reporting requirement for device trials - ANSWER -Within 10 working/business
days for both investigator and Sponsor
Consent and Assent Requirements for research involving children - ANSWER -1.
Parental consent from one or both parents or LAR is required
2. Child assent may be required as determined by the overseeing IRB.
