CCRP SOCRA STUDY GUIDE 2026 EXAM QUESTIONS AND
ANSWERS RATED A+
✔✔1) Fairness, potential participants should be treated equally
2)Benefit of research not restricted to those who can afford it
3)Research should not involve persons from groups not likely to benefit from application
of the research - ✔✔What does "Justice" entail?
✔✔Informed Consent - ✔✔ICH E6 Section 4.8
✔✔Informed consent - ✔✔What must be obtained from the subject or LAR prior to
initiating any research related exams?
✔✔When there is no additional relevant information to provide to the subject? -
✔✔When is the informed consent process over?
✔✔1) Statement that includes the nature of the research, the purpose, duration,
procedures and experimental procedures
2) Description of risks/discomforts
3) Benefits to the subjects or others
4)Alternative procedures or courses
5) Statement of record confidentiality
6) Compensation
7)Who to contact
8) statement that participation is voluntary - ✔✔What 8 ICF elements are required by 21
CFR 50
✔✔1) Risks to embryo or fetus
2) circumstances that might end trial
3)additional costs
4)approximate number of subjects
5)consequences of subject's decision to withdraw
6)significant new finding statement - ✔✔What additional elements can be included in an
ICF, but not required?
✔✔The Informed Consent Form - ✔✔What cannot contain language that waives or
appears to waive the rights of the subject?
✔✔The Informed Consent Form - ✔✔What cannot include language that releases or
appears to release investigator, institution, sponsor or their agents from liability for
negligence?
✔✔The Informed Consent Process - ✔✔When does the subject have the right to ask
questions about the study?
, ✔✔The subject only - ✔✔21 CFR Part 50 only requires who to sign the ICF?
✔✔Subject and person conducting the consent process - ✔✔ICH E6 guidelines requires
who to sign the ICF?
✔✔If the changes in the research trial affect the treatment of the subject, or may affect
the subject's willingness to continue in the study - ✔✔When must patient's be
reconsented?
✔✔To safeguard rights, safety and well being of all trial subjects
To pay special attention to trials that may include vulnerable subjects - ✔✔What are the
goals of an IRB? (21 CFR Part 56)
✔✔5 - ✔✔What is the minimum member requirement for an IRB?
✔✔Varied backgrounds, diversity and expertise
1 member with scientific expertise
1 member with nonscientific concern
1 member not affiliated with insitution - ✔✔How should an IRB be comprised?
✔✔Experts - ✔✔Who may assist the IRB in review and determinations, but not vote?
✔✔1) Prisoners
2) Pregnant women, children
3)Handicapped
4)mentally disabled
5)economically or educationally disadvantaged - ✔✔What populations are more likely to
be a vulnerable subject?
✔✔1) Protocol and amendments
2) ICF
3) Subject recruitment materials (ads)
4) IB
5)Available safety data
6) Information about payments/compensation to subjets
7)Current CV of Investigators - ✔✔What documents need to be submitted to the IRB?
✔✔1) Approval
2) Modifications needed
3) Disapproval - ✔✔What are the 3 outcomes of IRB review?
✔✔Expedited review - ✔✔What kind of review can be used for minor changes in
previously approved research?
ANSWERS RATED A+
✔✔1) Fairness, potential participants should be treated equally
2)Benefit of research not restricted to those who can afford it
3)Research should not involve persons from groups not likely to benefit from application
of the research - ✔✔What does "Justice" entail?
✔✔Informed Consent - ✔✔ICH E6 Section 4.8
✔✔Informed consent - ✔✔What must be obtained from the subject or LAR prior to
initiating any research related exams?
✔✔When there is no additional relevant information to provide to the subject? -
✔✔When is the informed consent process over?
✔✔1) Statement that includes the nature of the research, the purpose, duration,
procedures and experimental procedures
2) Description of risks/discomforts
3) Benefits to the subjects or others
4)Alternative procedures or courses
5) Statement of record confidentiality
6) Compensation
7)Who to contact
8) statement that participation is voluntary - ✔✔What 8 ICF elements are required by 21
CFR 50
✔✔1) Risks to embryo or fetus
2) circumstances that might end trial
3)additional costs
4)approximate number of subjects
5)consequences of subject's decision to withdraw
6)significant new finding statement - ✔✔What additional elements can be included in an
ICF, but not required?
✔✔The Informed Consent Form - ✔✔What cannot contain language that waives or
appears to waive the rights of the subject?
✔✔The Informed Consent Form - ✔✔What cannot include language that releases or
appears to release investigator, institution, sponsor or their agents from liability for
negligence?
✔✔The Informed Consent Process - ✔✔When does the subject have the right to ask
questions about the study?
, ✔✔The subject only - ✔✔21 CFR Part 50 only requires who to sign the ICF?
✔✔Subject and person conducting the consent process - ✔✔ICH E6 guidelines requires
who to sign the ICF?
✔✔If the changes in the research trial affect the treatment of the subject, or may affect
the subject's willingness to continue in the study - ✔✔When must patient's be
reconsented?
✔✔To safeguard rights, safety and well being of all trial subjects
To pay special attention to trials that may include vulnerable subjects - ✔✔What are the
goals of an IRB? (21 CFR Part 56)
✔✔5 - ✔✔What is the minimum member requirement for an IRB?
✔✔Varied backgrounds, diversity and expertise
1 member with scientific expertise
1 member with nonscientific concern
1 member not affiliated with insitution - ✔✔How should an IRB be comprised?
✔✔Experts - ✔✔Who may assist the IRB in review and determinations, but not vote?
✔✔1) Prisoners
2) Pregnant women, children
3)Handicapped
4)mentally disabled
5)economically or educationally disadvantaged - ✔✔What populations are more likely to
be a vulnerable subject?
✔✔1) Protocol and amendments
2) ICF
3) Subject recruitment materials (ads)
4) IB
5)Available safety data
6) Information about payments/compensation to subjets
7)Current CV of Investigators - ✔✔What documents need to be submitted to the IRB?
✔✔1) Approval
2) Modifications needed
3) Disapproval - ✔✔What are the 3 outcomes of IRB review?
✔✔Expedited review - ✔✔What kind of review can be used for minor changes in
previously approved research?
