CCRP ACTUAL 2026 STUDY GUIDE QUESTIONS AND
SOLUTIONS RATED A+
✔✔What 2 criteria must research in kids with > minimal risk and prospect of benefit
meet to be IRB-approved? - ✔✔1) Risk is justified by benefit
2) Relationship of risk to benefit is at least as favorable as any alternative
✔✔What 3 criteria must research in kids with > minimal risk and no benefit meet to be
IRB-approved? - ✔✔1) Risk is minor increase over minimal
2) Intervention experience is reasonably comparable to clinical care
3) Knowledge will be generalizeable
✔✔What criterion must otherwise unapprovable research in kids meet to be IRB-
approved? - ✔✔Presents opportunity to further understand, prevent or alleviate a
significant problem affecting health/welfare of children and conducted with sound ethical
principles
✔✔Who determines whether consent is needed from child, mom and/or dad? - ✔✔IRB
✔✔What 3 criteria should IRB consider when determining assent requirements? - ✔✔1)
Nature of research
2) Child's age, status and condition
3) Whether all or some of children to be included will be capable of assenting
✔✔What should happen when a child research subject turns 18? - ✔✔Re-consent
✔✔What 2 additional protections are afforded child wards of the state? - ✔✔1)
Research > minimal risk w/ no benefit must be directly related to wards or conducted in
setting where majority of kids aren't wards
2) Advocate must be appointed by IRB to give consent for study participation and
protect child's interests
✔✔What FDA regulations govern financial disclosure? - ✔✔21 CFR 54
✔✔In what ways may sponsors provide investigator financial disclosures to the FDA?
(3) - ✔✔1) FDA Form 3454 - no financial interests
2) FDA Form 3455 - complete disclosure statement
3) FDA Form 3454/option 3 - no financial disclosure obtained after due diligence
✔✔What relationships are considered when reporting a financial disclosure? -
✔✔Investigator, spouse and dependent children
✔✔What 5 scenarios require financial disclosure? - ✔✔1) Compensation to PI affected
by study outcome
,2) Proprietary interest in tested product
3) Equity interest in sponsor of study whose value can't be determined during time or
study or for 1 yr after
4) Stock in sponsor $50k+ held during study and for 1 yr after
5) Significant payments of $25k+ from sponsor to investigator during study and for 1 yr
after
✔✔For what time period must financial interests be disclosed? - ✔✔During course of
study + 1 yr after completion (Course of study: from date PI signs agreement with
sponsor to date all subject follow up completed or study cancelled)
✔✔What FDA regulations govern IRB related topics? - ✔✔21 CFR 56
✔✔IRBs must develop SOPs for which 6 items? - ✔✔1) Conducting initial and
continuing review
2) Reporting findings and actions to investigator and institution
3) Determining which project require more review
4) Ensuring prompt reporting of changes in research activity
5) Ensuring changes are not initiated without IRB approval
6) Ensuring prompt reporting to IRB, sponsor and FDA about UAPs, noncompliance,
suspension and termination
✔✔What criteria should IRBs strive to achieve in membership (4) - ✔✔1) One member
with scientific expertise
2) One member who is non-scientific
3) One member not affiliated with the institution
4) Both men and women
✔✔What 11 components should IRB applications include? - ✔✔1) Purpose of research
2) Scientific rationale
3) Research setting
4) Whether participants will be vulnerable to coercion/undue influence
5) Inc/exc criteria
6) Recruitment/enrollment procedures
7) Method of advertising
8) Time required to participate
9) Procedures
10) Payment amount and schedule
11) Risks/benefits
✔✔What is the definition of minimal risk? - ✔✔Probability and magnitude of harm
anticipated aren't greater than those ordinarily encountered in daily life during
performance of routine physical or psychological exams/tests (21 CFR 56.102(i)
✔✔When may an IRB use expedited review processes? (2) - ✔✔One or both:
, 1) Some or all of research is no more than minimal risk
2) Minor changes in previously approved research during approval period
✔✔What are the three types of medical device studies listed under IDE regulation (21
CFR 812)? - ✔✔1) Significant risk
2) Non-significant risk
3) Exempt
✔✔Who determines whether a device trial is SR, NSR or exempt? -
✔✔Sponsor/investigator makes suggestion > IRB makes decision > FDA confirms
✔✔What are the 4 criteria that define a significant risk device? (21 CFR 812.3(m)) -
✔✔1) Intended as an implant
2) Represented to be for use in supporting/sustaining life
3) Use is of substantial importance in diagnosing, curing, mitigating or treating disease,
or otherwise preventing impairment of health
- All of the above: and presents potential for serious risk to health, safety or welfare of
subjects
4) Otherwise presents potential for serious risk to health, safety or welfare of subjects
✔✔What is the definition of a Non-Significant Risk device? - ✔✔Doesn't meet criteria of
a significant risk device. Not necessarily a minimal risk study.
✔✔What regulations must SR studies follow? (2) - ✔✔1) Follow all IDE regulations in 21
CFR 812
2) Have IDE application approved by FDA prior to study start
✔✔What regulations must NSR studies follow? (3) - ✔✔1) Follow abbreviated IDE
regulations (21 CFR 812(b))
2) Don't need IDE application approved by FDA
3) Sponsors/IRBs don't have to report to FDA prior to study start
✔✔What are the 7 options for exempt device studies? - ✔✔1) In distribution before
5/1976
2) Device substantially equivalent to one meeting criteria 1 and is used following FDA
labeling
3) Diagnostic device that meets 4 criteria (not invasive, introduce energy or used w/o
confirmation by other diagnostic device)
4) Undergoing consumer testing, modification testing or combination testing if subjects
not at risk
5) Veterinary use
6) Lab animal use
7) Custom device unless being tested for commercial distribution
SOLUTIONS RATED A+
✔✔What 2 criteria must research in kids with > minimal risk and prospect of benefit
meet to be IRB-approved? - ✔✔1) Risk is justified by benefit
2) Relationship of risk to benefit is at least as favorable as any alternative
✔✔What 3 criteria must research in kids with > minimal risk and no benefit meet to be
IRB-approved? - ✔✔1) Risk is minor increase over minimal
2) Intervention experience is reasonably comparable to clinical care
3) Knowledge will be generalizeable
✔✔What criterion must otherwise unapprovable research in kids meet to be IRB-
approved? - ✔✔Presents opportunity to further understand, prevent or alleviate a
significant problem affecting health/welfare of children and conducted with sound ethical
principles
✔✔Who determines whether consent is needed from child, mom and/or dad? - ✔✔IRB
✔✔What 3 criteria should IRB consider when determining assent requirements? - ✔✔1)
Nature of research
2) Child's age, status and condition
3) Whether all or some of children to be included will be capable of assenting
✔✔What should happen when a child research subject turns 18? - ✔✔Re-consent
✔✔What 2 additional protections are afforded child wards of the state? - ✔✔1)
Research > minimal risk w/ no benefit must be directly related to wards or conducted in
setting where majority of kids aren't wards
2) Advocate must be appointed by IRB to give consent for study participation and
protect child's interests
✔✔What FDA regulations govern financial disclosure? - ✔✔21 CFR 54
✔✔In what ways may sponsors provide investigator financial disclosures to the FDA?
(3) - ✔✔1) FDA Form 3454 - no financial interests
2) FDA Form 3455 - complete disclosure statement
3) FDA Form 3454/option 3 - no financial disclosure obtained after due diligence
✔✔What relationships are considered when reporting a financial disclosure? -
✔✔Investigator, spouse and dependent children
✔✔What 5 scenarios require financial disclosure? - ✔✔1) Compensation to PI affected
by study outcome
,2) Proprietary interest in tested product
3) Equity interest in sponsor of study whose value can't be determined during time or
study or for 1 yr after
4) Stock in sponsor $50k+ held during study and for 1 yr after
5) Significant payments of $25k+ from sponsor to investigator during study and for 1 yr
after
✔✔For what time period must financial interests be disclosed? - ✔✔During course of
study + 1 yr after completion (Course of study: from date PI signs agreement with
sponsor to date all subject follow up completed or study cancelled)
✔✔What FDA regulations govern IRB related topics? - ✔✔21 CFR 56
✔✔IRBs must develop SOPs for which 6 items? - ✔✔1) Conducting initial and
continuing review
2) Reporting findings and actions to investigator and institution
3) Determining which project require more review
4) Ensuring prompt reporting of changes in research activity
5) Ensuring changes are not initiated without IRB approval
6) Ensuring prompt reporting to IRB, sponsor and FDA about UAPs, noncompliance,
suspension and termination
✔✔What criteria should IRBs strive to achieve in membership (4) - ✔✔1) One member
with scientific expertise
2) One member who is non-scientific
3) One member not affiliated with the institution
4) Both men and women
✔✔What 11 components should IRB applications include? - ✔✔1) Purpose of research
2) Scientific rationale
3) Research setting
4) Whether participants will be vulnerable to coercion/undue influence
5) Inc/exc criteria
6) Recruitment/enrollment procedures
7) Method of advertising
8) Time required to participate
9) Procedures
10) Payment amount and schedule
11) Risks/benefits
✔✔What is the definition of minimal risk? - ✔✔Probability and magnitude of harm
anticipated aren't greater than those ordinarily encountered in daily life during
performance of routine physical or psychological exams/tests (21 CFR 56.102(i)
✔✔When may an IRB use expedited review processes? (2) - ✔✔One or both:
, 1) Some or all of research is no more than minimal risk
2) Minor changes in previously approved research during approval period
✔✔What are the three types of medical device studies listed under IDE regulation (21
CFR 812)? - ✔✔1) Significant risk
2) Non-significant risk
3) Exempt
✔✔Who determines whether a device trial is SR, NSR or exempt? -
✔✔Sponsor/investigator makes suggestion > IRB makes decision > FDA confirms
✔✔What are the 4 criteria that define a significant risk device? (21 CFR 812.3(m)) -
✔✔1) Intended as an implant
2) Represented to be for use in supporting/sustaining life
3) Use is of substantial importance in diagnosing, curing, mitigating or treating disease,
or otherwise preventing impairment of health
- All of the above: and presents potential for serious risk to health, safety or welfare of
subjects
4) Otherwise presents potential for serious risk to health, safety or welfare of subjects
✔✔What is the definition of a Non-Significant Risk device? - ✔✔Doesn't meet criteria of
a significant risk device. Not necessarily a minimal risk study.
✔✔What regulations must SR studies follow? (2) - ✔✔1) Follow all IDE regulations in 21
CFR 812
2) Have IDE application approved by FDA prior to study start
✔✔What regulations must NSR studies follow? (3) - ✔✔1) Follow abbreviated IDE
regulations (21 CFR 812(b))
2) Don't need IDE application approved by FDA
3) Sponsors/IRBs don't have to report to FDA prior to study start
✔✔What are the 7 options for exempt device studies? - ✔✔1) In distribution before
5/1976
2) Device substantially equivalent to one meeting criteria 1 and is used following FDA
labeling
3) Diagnostic device that meets 4 criteria (not invasive, introduce energy or used w/o
confirmation by other diagnostic device)
4) Undergoing consumer testing, modification testing or combination testing if subjects
not at risk
5) Veterinary use
6) Lab animal use
7) Custom device unless being tested for commercial distribution
