CCRP SOCRA UPDATED 2026 EXAM SCRIPT QUESTIONS
AND ANSWERS RATED A+
✔✔What is the primary purpose of the IRB? - ✔✔to assure protection of rights and
welfare of human subjects
✔✔"active protocol" - ✔✔initial review and continuing review every 12 months
✔✔How often do IRB's have to renew registration? - ✔✔every 3 years
✔✔IRB must send any info changes within ____ days of change - ✔✔90
✔✔IRB requirements - ✔✔1) at least 5 members
2) 1 member whose primary concerns are in the scientific area
3) 1 member whose primary concerns are in a nonscientific area
4) 1 member not affiliated with the institution
5) no IRB members can have conflicts of interest
6) the IRB can invite individuals with expertise in complex areas
✔✔Vulnerable people - ✔✔children, prisoners, pregnant women, physically or mentally
disabled people, economically or educationally disadvantaged people
✔✔True or False: As long as there is a potential for benefit, extremity of risk does not
matter - ✔✔risk must be reasonable in relation to anticipated benefits
✔✔CRF 56.110 Subpart D - ✔✔FDA may restrict, suspend, or terminated institution's or
IRB's use of expedited review to protect rights and wellbeing of subjects
✔✔Examples of research that can utilize expedited review - ✔✔research involving no
more than minimal risk, minor changes in approved research
✔✔Who has the power to disqualify an IRB? - ✔✔the Commissioner, notice is then sent
to FDA
✔✔When and why is joint review used? - ✔✔for multi-institutional studies to avoid
duplication of effort
✔✔IEC - ✔✔Independent Ethics Committee, includes IRBs
✔✔IND should be labeled with ____________ - ✔✔Caution: new drug with no false or
misleading claims
✔✔IND Phase 1 - ✔✔initial introduction to determine metabolism, pharma actions of
drug on humans, side effects, to gain early evidence of effectiveness. for 20-80 patients
, ✔✔IND Phase 2 - ✔✔evaluate effectiveness of drug for particular indication, determine
short term side effects and risks. for 100s of patients
✔✔IND Phase 3 - ✔✔expanded controlled and uncontrolled clinical trials, preliminary
effectiveness, additional safety info, evaluation of benefit-risk relationship, basis for
physician labeling. for 100s-1000s of patients
✔✔When to protocol, content, investigator, etc. Changes need to be submitted as
amendments? - ✔✔30-day intervals prior to implementation
✔✔IP must provide what in protocol? - ✔✔-drug substance and formula
-effects on animals and humans
-safety and effectiveness
-possible risks and side effects
-pharma and toxicology reports (any in vitro and effects on fetus)
-radioactivity and absorption of dose
✔✔adverse event - ✔✔any untoward medical occurrence associated with the use of a
drug (whether or not it is related to drug)
✔✔serious AE - ✔✔-life-threatening (or results in death)
-results in hospitalization or prolongation
-substantial disruption of ability to conduct normal life
-congenital anomaly/birth defect
✔✔suspected AE - ✔✔reasonable possibility drug caused AE, causal relationship
✔✔unexpected AE - ✔✔if not listed in investigator brochure, not specifically observed,
or not consistent with risk info
✔✔Who must review safety info of investigational drug? - ✔✔sponsor
✔✔__________ must notify ________ and ________________ of safety risks
regarding an IND within _____ days - ✔✔sponsor must notify FDA and investigators
within 15 calendar days
✔✔Sponsor must report AEs that are ________ and ________ - ✔✔serious and
unexpected (if there is evidence to suggest causal relationship with drug)
✔✔___________ must report study endpoints to __________ - ✔✔sponsor to FDA
✔✔How soon do sponsors have to report any fatal or life-threatening AEs? - ✔✔within 7
days of initial notification
AND ANSWERS RATED A+
✔✔What is the primary purpose of the IRB? - ✔✔to assure protection of rights and
welfare of human subjects
✔✔"active protocol" - ✔✔initial review and continuing review every 12 months
✔✔How often do IRB's have to renew registration? - ✔✔every 3 years
✔✔IRB must send any info changes within ____ days of change - ✔✔90
✔✔IRB requirements - ✔✔1) at least 5 members
2) 1 member whose primary concerns are in the scientific area
3) 1 member whose primary concerns are in a nonscientific area
4) 1 member not affiliated with the institution
5) no IRB members can have conflicts of interest
6) the IRB can invite individuals with expertise in complex areas
✔✔Vulnerable people - ✔✔children, prisoners, pregnant women, physically or mentally
disabled people, economically or educationally disadvantaged people
✔✔True or False: As long as there is a potential for benefit, extremity of risk does not
matter - ✔✔risk must be reasonable in relation to anticipated benefits
✔✔CRF 56.110 Subpart D - ✔✔FDA may restrict, suspend, or terminated institution's or
IRB's use of expedited review to protect rights and wellbeing of subjects
✔✔Examples of research that can utilize expedited review - ✔✔research involving no
more than minimal risk, minor changes in approved research
✔✔Who has the power to disqualify an IRB? - ✔✔the Commissioner, notice is then sent
to FDA
✔✔When and why is joint review used? - ✔✔for multi-institutional studies to avoid
duplication of effort
✔✔IEC - ✔✔Independent Ethics Committee, includes IRBs
✔✔IND should be labeled with ____________ - ✔✔Caution: new drug with no false or
misleading claims
✔✔IND Phase 1 - ✔✔initial introduction to determine metabolism, pharma actions of
drug on humans, side effects, to gain early evidence of effectiveness. for 20-80 patients
, ✔✔IND Phase 2 - ✔✔evaluate effectiveness of drug for particular indication, determine
short term side effects and risks. for 100s of patients
✔✔IND Phase 3 - ✔✔expanded controlled and uncontrolled clinical trials, preliminary
effectiveness, additional safety info, evaluation of benefit-risk relationship, basis for
physician labeling. for 100s-1000s of patients
✔✔When to protocol, content, investigator, etc. Changes need to be submitted as
amendments? - ✔✔30-day intervals prior to implementation
✔✔IP must provide what in protocol? - ✔✔-drug substance and formula
-effects on animals and humans
-safety and effectiveness
-possible risks and side effects
-pharma and toxicology reports (any in vitro and effects on fetus)
-radioactivity and absorption of dose
✔✔adverse event - ✔✔any untoward medical occurrence associated with the use of a
drug (whether or not it is related to drug)
✔✔serious AE - ✔✔-life-threatening (or results in death)
-results in hospitalization or prolongation
-substantial disruption of ability to conduct normal life
-congenital anomaly/birth defect
✔✔suspected AE - ✔✔reasonable possibility drug caused AE, causal relationship
✔✔unexpected AE - ✔✔if not listed in investigator brochure, not specifically observed,
or not consistent with risk info
✔✔Who must review safety info of investigational drug? - ✔✔sponsor
✔✔__________ must notify ________ and ________________ of safety risks
regarding an IND within _____ days - ✔✔sponsor must notify FDA and investigators
within 15 calendar days
✔✔Sponsor must report AEs that are ________ and ________ - ✔✔serious and
unexpected (if there is evidence to suggest causal relationship with drug)
✔✔___________ must report study endpoints to __________ - ✔✔sponsor to FDA
✔✔How soon do sponsors have to report any fatal or life-threatening AEs? - ✔✔within 7
days of initial notification
