SOCRA PRACTICE TEST 3 MOCK EXAM WITH
ANSWER RATIONALES 2026
◉ What is the minimum number of members required by an IRB
Answer: 5
◉ Which of the following are necessary to waive consent?
A.Subject is unable to give consent
B.No time or unable to contact next of kin
C.Life-Threatening Condition
D.No other treatment available
E.All of the above
Answer: all of the above
◉ This form is used for the mandatory reporting of adverse events
and product problems
A. 3500 A
B. 1572
C. 3611
,Answer: A. 3500 A
◉ 3 Ethical Principals of Respect for Persons, Beneficence and
Justice are outlined in
A.ICH EC GCP
B.45 CFR 46
C.The Belmont Report
D.The Nuremberg Code
E.Declaration of Helsinki
Answer: C.The Belmont Report
◉ The "Doctor's Trial" prompted the 1979 Belmont Report. t/f
Answer: false- tuskegee syphilis experiment
◉ The Nuremberg Code
Answer: Set of 10 ethical principles for human experimentation
developed in 1947; Resulted from trials held in Nuremberg,
Germany Along with the Declaration of Helsinki, are the basis for
CFR Title 45 Part 46
◉ Declaration of Helsinki
,Answer: Set of ethical principles regarding human experimentation
adopted by the World Medical Association (WMA) in June 1964, 7th
revision in October 2013
Declaration is morally binding on physicians, and that obligation
overrides any national or local laws or regulation; if the Declaration
provides for higher standard of protection of humans than the latter.
◉ Informed consent documents must include the following
A.A statement that the study involves research
B.A statement of possible risk
C.A discussion of possible alternative treatments
D.All of the Above
Answer: D.All of the Above
◉ Who signs Short forms and who gets copies
Answer: -Short Form to be signed by Subject or LAR
-WITNESS signs both Short Form & Copy of summary
-Person obtaining consent shall sign a copy of summary
-Copy of Summary shall be given to the subject or LAR in addition to
copy of short form
, ◉ The responsibility of the individual participant safety lies with
A.The sponsor
B.The investigator
C.The IRB
Answer: B.The investigator
◉ Which of the following would generally indicate the breaking of a
randomization code in a blinded study
A.The participant withdraws from the study prior to its conclusion
B.Participants in only one of the investigating sites shows any
definite response to treatment
C.A participant experiences a Serious Adverse Event, the etiology of
which cannot be explained
Answer: C.A participant experiences a Serious Adverse Event, the
etiology of which cannot be explained
◉ A drug's safety is determined by which of the following criteria?
A.The dose at which no side effects are reported
B.The absence of harmful side effects on the individuals exposed to
it so far
ANSWER RATIONALES 2026
◉ What is the minimum number of members required by an IRB
Answer: 5
◉ Which of the following are necessary to waive consent?
A.Subject is unable to give consent
B.No time or unable to contact next of kin
C.Life-Threatening Condition
D.No other treatment available
E.All of the above
Answer: all of the above
◉ This form is used for the mandatory reporting of adverse events
and product problems
A. 3500 A
B. 1572
C. 3611
,Answer: A. 3500 A
◉ 3 Ethical Principals of Respect for Persons, Beneficence and
Justice are outlined in
A.ICH EC GCP
B.45 CFR 46
C.The Belmont Report
D.The Nuremberg Code
E.Declaration of Helsinki
Answer: C.The Belmont Report
◉ The "Doctor's Trial" prompted the 1979 Belmont Report. t/f
Answer: false- tuskegee syphilis experiment
◉ The Nuremberg Code
Answer: Set of 10 ethical principles for human experimentation
developed in 1947; Resulted from trials held in Nuremberg,
Germany Along with the Declaration of Helsinki, are the basis for
CFR Title 45 Part 46
◉ Declaration of Helsinki
,Answer: Set of ethical principles regarding human experimentation
adopted by the World Medical Association (WMA) in June 1964, 7th
revision in October 2013
Declaration is morally binding on physicians, and that obligation
overrides any national or local laws or regulation; if the Declaration
provides for higher standard of protection of humans than the latter.
◉ Informed consent documents must include the following
A.A statement that the study involves research
B.A statement of possible risk
C.A discussion of possible alternative treatments
D.All of the Above
Answer: D.All of the Above
◉ Who signs Short forms and who gets copies
Answer: -Short Form to be signed by Subject or LAR
-WITNESS signs both Short Form & Copy of summary
-Person obtaining consent shall sign a copy of summary
-Copy of Summary shall be given to the subject or LAR in addition to
copy of short form
, ◉ The responsibility of the individual participant safety lies with
A.The sponsor
B.The investigator
C.The IRB
Answer: B.The investigator
◉ Which of the following would generally indicate the breaking of a
randomization code in a blinded study
A.The participant withdraws from the study prior to its conclusion
B.Participants in only one of the investigating sites shows any
definite response to treatment
C.A participant experiences a Serious Adverse Event, the etiology of
which cannot be explained
Answer: C.A participant experiences a Serious Adverse Event, the
etiology of which cannot be explained
◉ A drug's safety is determined by which of the following criteria?
A.The dose at which no side effects are reported
B.The absence of harmful side effects on the individuals exposed to
it so far
