SOCRA EXAMINATION 2026 SET QUESTIONS AND
SOLUTIONS RATED A+
✔✔What should drug accountability records include? - ✔✔-Inventory of product/drug
-Dispensation records
-Batch information/expiration dates, etc
✔✔What year was The Nuremburg Code established? - ✔✔1949
✔✔What year was the Declaration of Helsinki established? - ✔✔1964
✔✔What year was the Belmont Report established? - ✔✔1979
✔✔What year was the National Research Act passed by Congress? - ✔✔1974
✔✔What are the 3 Principles of Belmont Report? - ✔✔-Respect for Persons
-Beneficence
-Justice
✔✔Respect for Persons - ✔✔-Individuals to be treated as automous agents &
acknowledged as such
-Persons w/diminished autonomy are entitled to & need protection
✔✔Beneficience - ✔✔-Do not harm
-Maximize possible benefits while minimizing possible harms
✔✔Justice - ✔✔-"Fairness of distribution" or "What is Deserved"
-To each person an equal share (Fair procedures/outcomes in the selection of subjects)
✔✔Short form written consent - ✔✔-Can be used with IRB approval and is most often
used for Subjects who cannot read.
-Needs an impartial witness to consent process
-Study consent form should be read and explained to subject
-Needs oral consent
-Witness signature
-Person obtaining consent signs
✔✔Required signatures for consent - ✔✔-CFR requires only the subject to sign
-ICH requires the subject + person obtaining consent to sign
✔✔Exceptions to informed consent - ✔✔-Subject is unable to consent (unable to
communicate)
-Life-threatening condition
-Insufficient time to obtain consent
, -No available alternative therapy
✔✔What is the necessary follow-up after making an exception to informed consent? -
✔✔Within 5 working days, a physician not associated with the clinical trial should review
the use and make a written evaluation and then that documentation must be submitted
to the IRB.
✔✔21 CFR Part 56 - ✔✔Institutional Review Boards
✔✔How many Board Members must an IRB have? - ✔✔5
✔✔FDA criteria for IRB Board Members? - ✔✔-They must have varied backgrounds.
-At least one member must have scientific expertise.
-At least one member whose primary concern is non-scientific.
-At least one member not affiliated with the institution.
-No conflicts of interest.
✔✔IRB Progress Reports should include: - ✔✔-Number of Subjects entered
-Number if subjects withdrawn and reasons why
-Summary of experiences
-Research results thus far
-Current risk/benefits assessment
✔✔Common study designs - ✔✔Crossover (bioquivalence)
Dose escalation (tolerance)
Parallel Group (efficacy and safety)
Dose range (multiple doses of investigational product)
Uncontrolled (long term extension studies)
✔✔Four types of controls - ✔✔-Placebo
-Active treatment
-Dose comparison
-No treatment
✔✔Active treatment - ✔✔Comparative treatment has a similar mechanism of action as
investigational product and is considered standard of care. Used when placebo
treatment for condition is unethical.
✔✔No treatment - ✔✔Long term safety studies for chronic conditions (hypertension).
Meant to assess maintenance of clinical response over time and safety.
✔✔Unexpected Adverse Event or Unexpected Adverse Reaction - ✔✔Is one that has
not been identified in nature, severity, or frequency in the current Investigator's
Brochure.
SOLUTIONS RATED A+
✔✔What should drug accountability records include? - ✔✔-Inventory of product/drug
-Dispensation records
-Batch information/expiration dates, etc
✔✔What year was The Nuremburg Code established? - ✔✔1949
✔✔What year was the Declaration of Helsinki established? - ✔✔1964
✔✔What year was the Belmont Report established? - ✔✔1979
✔✔What year was the National Research Act passed by Congress? - ✔✔1974
✔✔What are the 3 Principles of Belmont Report? - ✔✔-Respect for Persons
-Beneficence
-Justice
✔✔Respect for Persons - ✔✔-Individuals to be treated as automous agents &
acknowledged as such
-Persons w/diminished autonomy are entitled to & need protection
✔✔Beneficience - ✔✔-Do not harm
-Maximize possible benefits while minimizing possible harms
✔✔Justice - ✔✔-"Fairness of distribution" or "What is Deserved"
-To each person an equal share (Fair procedures/outcomes in the selection of subjects)
✔✔Short form written consent - ✔✔-Can be used with IRB approval and is most often
used for Subjects who cannot read.
-Needs an impartial witness to consent process
-Study consent form should be read and explained to subject
-Needs oral consent
-Witness signature
-Person obtaining consent signs
✔✔Required signatures for consent - ✔✔-CFR requires only the subject to sign
-ICH requires the subject + person obtaining consent to sign
✔✔Exceptions to informed consent - ✔✔-Subject is unable to consent (unable to
communicate)
-Life-threatening condition
-Insufficient time to obtain consent
, -No available alternative therapy
✔✔What is the necessary follow-up after making an exception to informed consent? -
✔✔Within 5 working days, a physician not associated with the clinical trial should review
the use and make a written evaluation and then that documentation must be submitted
to the IRB.
✔✔21 CFR Part 56 - ✔✔Institutional Review Boards
✔✔How many Board Members must an IRB have? - ✔✔5
✔✔FDA criteria for IRB Board Members? - ✔✔-They must have varied backgrounds.
-At least one member must have scientific expertise.
-At least one member whose primary concern is non-scientific.
-At least one member not affiliated with the institution.
-No conflicts of interest.
✔✔IRB Progress Reports should include: - ✔✔-Number of Subjects entered
-Number if subjects withdrawn and reasons why
-Summary of experiences
-Research results thus far
-Current risk/benefits assessment
✔✔Common study designs - ✔✔Crossover (bioquivalence)
Dose escalation (tolerance)
Parallel Group (efficacy and safety)
Dose range (multiple doses of investigational product)
Uncontrolled (long term extension studies)
✔✔Four types of controls - ✔✔-Placebo
-Active treatment
-Dose comparison
-No treatment
✔✔Active treatment - ✔✔Comparative treatment has a similar mechanism of action as
investigational product and is considered standard of care. Used when placebo
treatment for condition is unethical.
✔✔No treatment - ✔✔Long term safety studies for chronic conditions (hypertension).
Meant to assess maintenance of clinical response over time and safety.
✔✔Unexpected Adverse Event or Unexpected Adverse Reaction - ✔✔Is one that has
not been identified in nature, severity, or frequency in the current Investigator's
Brochure.
