SOCRA CERTIFICATION 2026 EXAMS TEST PAPER
QUESTIONS AND ANSWERS SURE A+
✔✔CRO - ✔✔(Contract Research Organization) Company contracted by Sponsor to run
some aspects of the study such as monitoring, contract negotiations, payments, etc..
FDA requires delegated trial responsibilities in writing from the Sponsor because FDA
and IRB consider the CRO to be the same as "Sponsor".
✔✔SMO - ✔✔(Site Management Organization) Company contracted by the Sponsor to
find and manage the sites conducting the study.
✔✔Investigator's Brochure - ✔✔Reviewed annually, revised as needed.
✔✔Pre-Clinical Research - ✔✔Chemical synthesis and initial chemical development
conducted on animals or on cell cultures.
✔✔Phase 1 Clinical Trials - ✔✔-Initial introduction of investigational new drug into
humans.
-Closely monitored, may include patients/normal Subjects
-Designed to determine metabolism and pharmacologic actions of drug in humans, side
effects with increasing doses to gain early evidence on effectiveness.
-Also includes studies of drug metabolism, structure-activity relationships, and
mechanism of action in humans, and studies in which investigational drugs are used as
research tool to explore biological phenomena or disease processes
-Total number of Subjects = 20-80
-Data collected: pharmacodynamics, pharmacokinetics, bioavailability, bioequivalence,
dose proportionality. (Safety, vital signs, plasma and serum concentrations, side
effects).
✔✔Phase II Clinical Trials - ✔✔-Controlled studies conducted to evaluate the
effectiveness of the drug for a particular.indication(s) in patients with the
disease/condition under study.
-Well-controlled, closely monitored
-Determines common short-term side effects and risks associated with the drug.
, -Relatively small total number of subjects usually no more than several hundred.
✔✔Phase III Clinical Trials - ✔✔-Expanded controlled and uncontrolled trials.
-Performed after preliminary evidence suggests effectiveness of drug has been
obtained.
-Intended to gather additional information about effectiveness and safety needed to
evaluate benefit-risk relationship to provide adequate physician labeling.
-Total number of Subjects between several hundred to several thousand.
✔✔Phase IV Clinical Trials - ✔✔Concurrent with marketing approval, FDA may request
sponsor conduct certain "postmarketing" studies to delineate additional information
about drug's risks, benefits and optimal use.
Examples: Fast-tracked drug studies that evaluate age and ethic groups, safety,
pharmacoeconomic data, and it's marketing launch.
✔✔21 CFR Part 50 - ✔✔Informed consent
✔✔Exceptions to informed consent - ✔✔- Life threatening situations.
- Informed consent cannot be obtained from subjects.
- Insufficient time to consent LAR.
- No alternative approved or general recognized therapy that affords the Subjects a
better chance of survival.
✔✔PI doesn't have time to consult with another physician - ✔✔- Must have information
reviewed and evaluated in writing by a physician who is not participating in the research
within 5 working days.
- Submit to the IRB within 5 working days of using test article.
- Can be waived when requested by the secretary of defense when an IND is sponsored
by the department of defense.
- DOD request for the waiver of IC must be limited to a specific military operation
involving combat or the immediate threat of combat
✔✔Emergency research waiver - ✔✔-Subjects are in a life-threatening situation and
available treatments are unproven or unsatisfactory. -Obtaining consent is not feasible,
due to medical condition, no time for LSR, no way to prospectively identify subject.
-Research must hold a prospect of direct benefit.
-Research could not be practically carried out without the waiver. Protocol defines
length of participants and attempts will be made to consent the subjects or LAR within
that time.
-Emergency research waiver is a waiver of time not necessity.
✔✔21 CFR Part 20.25 (8 requirements of consent) - ✔✔-Research is involved
-Contact info (IRB, Investigator, Sponsor)
-Treatment alternatives
-Risks and discomforts
QUESTIONS AND ANSWERS SURE A+
✔✔CRO - ✔✔(Contract Research Organization) Company contracted by Sponsor to run
some aspects of the study such as monitoring, contract negotiations, payments, etc..
FDA requires delegated trial responsibilities in writing from the Sponsor because FDA
and IRB consider the CRO to be the same as "Sponsor".
✔✔SMO - ✔✔(Site Management Organization) Company contracted by the Sponsor to
find and manage the sites conducting the study.
✔✔Investigator's Brochure - ✔✔Reviewed annually, revised as needed.
✔✔Pre-Clinical Research - ✔✔Chemical synthesis and initial chemical development
conducted on animals or on cell cultures.
✔✔Phase 1 Clinical Trials - ✔✔-Initial introduction of investigational new drug into
humans.
-Closely monitored, may include patients/normal Subjects
-Designed to determine metabolism and pharmacologic actions of drug in humans, side
effects with increasing doses to gain early evidence on effectiveness.
-Also includes studies of drug metabolism, structure-activity relationships, and
mechanism of action in humans, and studies in which investigational drugs are used as
research tool to explore biological phenomena or disease processes
-Total number of Subjects = 20-80
-Data collected: pharmacodynamics, pharmacokinetics, bioavailability, bioequivalence,
dose proportionality. (Safety, vital signs, plasma and serum concentrations, side
effects).
✔✔Phase II Clinical Trials - ✔✔-Controlled studies conducted to evaluate the
effectiveness of the drug for a particular.indication(s) in patients with the
disease/condition under study.
-Well-controlled, closely monitored
-Determines common short-term side effects and risks associated with the drug.
, -Relatively small total number of subjects usually no more than several hundred.
✔✔Phase III Clinical Trials - ✔✔-Expanded controlled and uncontrolled trials.
-Performed after preliminary evidence suggests effectiveness of drug has been
obtained.
-Intended to gather additional information about effectiveness and safety needed to
evaluate benefit-risk relationship to provide adequate physician labeling.
-Total number of Subjects between several hundred to several thousand.
✔✔Phase IV Clinical Trials - ✔✔Concurrent with marketing approval, FDA may request
sponsor conduct certain "postmarketing" studies to delineate additional information
about drug's risks, benefits and optimal use.
Examples: Fast-tracked drug studies that evaluate age and ethic groups, safety,
pharmacoeconomic data, and it's marketing launch.
✔✔21 CFR Part 50 - ✔✔Informed consent
✔✔Exceptions to informed consent - ✔✔- Life threatening situations.
- Informed consent cannot be obtained from subjects.
- Insufficient time to consent LAR.
- No alternative approved or general recognized therapy that affords the Subjects a
better chance of survival.
✔✔PI doesn't have time to consult with another physician - ✔✔- Must have information
reviewed and evaluated in writing by a physician who is not participating in the research
within 5 working days.
- Submit to the IRB within 5 working days of using test article.
- Can be waived when requested by the secretary of defense when an IND is sponsored
by the department of defense.
- DOD request for the waiver of IC must be limited to a specific military operation
involving combat or the immediate threat of combat
✔✔Emergency research waiver - ✔✔-Subjects are in a life-threatening situation and
available treatments are unproven or unsatisfactory. -Obtaining consent is not feasible,
due to medical condition, no time for LSR, no way to prospectively identify subject.
-Research must hold a prospect of direct benefit.
-Research could not be practically carried out without the waiver. Protocol defines
length of participants and attempts will be made to consent the subjects or LAR within
that time.
-Emergency research waiver is a waiver of time not necessity.
✔✔21 CFR Part 20.25 (8 requirements of consent) - ✔✔-Research is involved
-Contact info (IRB, Investigator, Sponsor)
-Treatment alternatives
-Risks and discomforts
