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NEW YORK CLINICAL RESEARCH
COORDINATOR CERTIFICATION ACTUAL
EXAM 2026/2027 COMPLETE ACCURATE
EXAM REAL QUESTIONS WITH WELL
ELABORATED ANSWERS AND RATIONALES.
(100% CORRECT VERIFIED SOLUTIONS)
1. A subject in a New York hospital experiences a serious
adverse event (SAE) that is unanticipated and possibly
related to the investigational drug. Within what timeframe
must the CRC report this to the IRB?
A) 5 business days
B) 24 hours
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C) 15 calendar days
D) Immediately but no later than 5 working days
Answer: D – NYS and federal regulations (21 CFR 312.32)
require unanticipated problems involving risks to subjects
(including SAEs possibly related to the drug) to be reported to
the IRB within 5 working days. If fatal/life-threatening, sponsor
may require 24-hour FDA reporting.
2. Under HIPAA, which of the following is considered
Protected Health Information (PHI) in a clinical trial? (Select
All That Apply)
A) Subject’s name
B) MRI images
C) Date of birth
D) De-identified lab results with no dates
Answer: A, B, C – PHI includes any identifiable health info:
names, images, dates (DOB, admission dates). De-identified
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data with no dates or identifiers is not PHI per the Safe
Harbor method.
3. A CRC in NYC discovers that a subject was enrolled
without signing the latest IRB-approved consent form. What
is the FIRST action?
A) Ask the subject to sign the new form immediately
B) Report to IRB and sponsor
C) Do nothing if the subject is still in the study
D) Have the PI notify legal department
Answer: B – This is a protocol deviation and potential
unverified consent. IRB and sponsor must be notified. Re-
consent may be needed after IRB guidance. Do not retro-sign.
4. The Belmont Report’s three ethical principles for human
subjects research are:
A) Justice, Beneficence, Respect for Persons
B) Confidentiality, Integrity, Safety
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C) Informed consent, IRB review, Data safety
D) Autonomy, Non-maleficence, Justice
Answer: A – Belmont: 1) Respect for Persons
(autonomy/protection of vulnerable), 2) Beneficence (maximize
benefits/minimize harms), 3) Justice (fair distribution of
burdens/benefits).
5. Scenario: A 17-year-old in NY wants to join a Phase 3
asthma trial. The study drug is not approved for minors.
What is required?
A) Parental permission + minor’s assent
B) Only parental permission
C) Emancipated minor can consent alone
D) Cannot enroll because drug is not approved for minors
Answer: A – For minors, parental permission + child’s assent
required per 45 CFR 46.408. IRB may waive assent if not
age-appropriate. Phase 3 may enroll minors with proper
consent.
NEW YORK CLINICAL RESEARCH
COORDINATOR CERTIFICATION ACTUAL
EXAM 2026/2027 COMPLETE ACCURATE
EXAM REAL QUESTIONS WITH WELL
ELABORATED ANSWERS AND RATIONALES.
(100% CORRECT VERIFIED SOLUTIONS)
1. A subject in a New York hospital experiences a serious
adverse event (SAE) that is unanticipated and possibly
related to the investigational drug. Within what timeframe
must the CRC report this to the IRB?
A) 5 business days
B) 24 hours
,Page 2 of 156
C) 15 calendar days
D) Immediately but no later than 5 working days
Answer: D – NYS and federal regulations (21 CFR 312.32)
require unanticipated problems involving risks to subjects
(including SAEs possibly related to the drug) to be reported to
the IRB within 5 working days. If fatal/life-threatening, sponsor
may require 24-hour FDA reporting.
2. Under HIPAA, which of the following is considered
Protected Health Information (PHI) in a clinical trial? (Select
All That Apply)
A) Subject’s name
B) MRI images
C) Date of birth
D) De-identified lab results with no dates
Answer: A, B, C – PHI includes any identifiable health info:
names, images, dates (DOB, admission dates). De-identified
,Page 3 of 156
data with no dates or identifiers is not PHI per the Safe
Harbor method.
3. A CRC in NYC discovers that a subject was enrolled
without signing the latest IRB-approved consent form. What
is the FIRST action?
A) Ask the subject to sign the new form immediately
B) Report to IRB and sponsor
C) Do nothing if the subject is still in the study
D) Have the PI notify legal department
Answer: B – This is a protocol deviation and potential
unverified consent. IRB and sponsor must be notified. Re-
consent may be needed after IRB guidance. Do not retro-sign.
4. The Belmont Report’s three ethical principles for human
subjects research are:
A) Justice, Beneficence, Respect for Persons
B) Confidentiality, Integrity, Safety
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C) Informed consent, IRB review, Data safety
D) Autonomy, Non-maleficence, Justice
Answer: A – Belmont: 1) Respect for Persons
(autonomy/protection of vulnerable), 2) Beneficence (maximize
benefits/minimize harms), 3) Justice (fair distribution of
burdens/benefits).
5. Scenario: A 17-year-old in NY wants to join a Phase 3
asthma trial. The study drug is not approved for minors.
What is required?
A) Parental permission + minor’s assent
B) Only parental permission
C) Emancipated minor can consent alone
D) Cannot enroll because drug is not approved for minors
Answer: A – For minors, parental permission + child’s assent
required per 45 CFR 46.408. IRB may waive assent if not
age-appropriate. Phase 3 may enroll minors with proper
consent.
