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NR 603 CEA EXAM LATEST VERSION 2026-2027 WITH
COMPLETE QUESTIONS WITH CORRECT SOLUTIONS ALL
WITH DETAILED RATIONALES JUST REALEASED
1. A clinical research coordinator is preparing for a site initiation visit and notices that the
protocol requires blood draws at 2, 6, and 12 hours post-dose. The lab kit contains only two sets
of collection tubes per subject. What is the most appropriate action?
A) Proceed with the visit and use the available tubes
B) Request additional lab kits from the sponsor immediately
C) Collect only the 2-hour and 12-hour samples
D) Use alternative tubes from the site's general supply
Correct Answer: B. The CRC must ensure all protocol-required materials are available before
study initiation; requesting additional kits is the correct action as protocol compliance is
mandatory and specimen collection cannot be compromised.*
2. During a subject’s follow-up visit, you discover that the subject took an over-the-counter
medication that is prohibited by the protocol. The subject took it three days ago and did not
report it. What should you do first?
A) Document the medication as a protocol deviation
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B) Withdraw the subject from the study immediately
C) Ask the subject to stop taking the medication going forward
D) Contact the principal investigator to determine if the subject can continue
Correct Answer: D. The PI must evaluate whether the prohibited medication affects subject
safety or data integrity; the CRC should not make unilateral decisions about subject
continuation.*
3. An investigator receives an unsolicited adverse event report for a subject who is no longer
participating in the study. The event occurred two months after the subject completed the final
study visit. What is the appropriate reporting timeline?
A) No reporting is required since the subject completed the study
B) Report within 24 hours if it is serious and related
C) Report at the next scheduled safety update
D) Report only if the event requires hospitalization
Correct Answer: B. Serious adverse events that are possibly related to the investigational
product must be reported even after study completion if they occur within the predefined follow-
up period, typically within 24 hours for serious unexpected suspected adverse reactions.*
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4. A subject arrives for a study visit and appears confused about the informed consent process.
The subject signed the consent form two weeks ago but now asks, “What exactly am I agreeing
to?” What is the CRC’s best response?
A) Remind the subject that they already signed the consent form
B) Re-explain the key elements of the study and assess understanding
C) Have the subject sign a new consent form
D) Ask the PI to speak with the subject
Correct Answer: B. Informed consent is an ongoing process; the CRC should re-explain the study,
assess comprehension, and document the conversation rather than assuming prior consent
remains valid.*
5. The study drug is stored in a refrigerator with a temperature range of 2–8°C. During morning
temperature checks, you find the log shows the refrigerator reached 10°C overnight. What is the
most appropriate immediate action?
A) Move all study drug to another refrigerator
B) Quarantine the affected drug and notify the sponsor
C) Continue using the drug since the excursion was minimal
D) Adjust the refrigerator thermostat and continue monitoring
Correct Answer: B. Any temperature excursion outside the labeled storage range requires
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quarantine of the affected product, notification of the sponsor or manufacturer, and evaluation
of stability impact before determining product usability.*
6. A subject reports mild nausea after the first dose of investigational product. The investigator
determines it is not serious and not related to the study drug. How should the CRC document
this?
A) As an adverse event with attribution of “not related”
B) As a serious adverse event due to the symptom
C) As a protocol deviation
D) It does not need to be documented since it is not related
Correct Answer: A. All adverse events, regardless of attribution, must be documented in the
source documents and case report forms; the investigator’s assessment of causality must be
recorded.*
7. During a monitoring visit, the CRA requests access to subject records that are stored in a
locked cabinet in the CRC’s office. The CRC is not present but has the only key. What should the
CRC do?
A) Give the key to the CRA so they can access the records
B) Arrange a time to be present when the CRA reviews the records
4
SUCCESS!
NR 603 CEA EXAM LATEST VERSION 2026-2027 WITH
COMPLETE QUESTIONS WITH CORRECT SOLUTIONS ALL
WITH DETAILED RATIONALES JUST REALEASED
1. A clinical research coordinator is preparing for a site initiation visit and notices that the
protocol requires blood draws at 2, 6, and 12 hours post-dose. The lab kit contains only two sets
of collection tubes per subject. What is the most appropriate action?
A) Proceed with the visit and use the available tubes
B) Request additional lab kits from the sponsor immediately
C) Collect only the 2-hour and 12-hour samples
D) Use alternative tubes from the site's general supply
Correct Answer: B. The CRC must ensure all protocol-required materials are available before
study initiation; requesting additional kits is the correct action as protocol compliance is
mandatory and specimen collection cannot be compromised.*
2. During a subject’s follow-up visit, you discover that the subject took an over-the-counter
medication that is prohibited by the protocol. The subject took it three days ago and did not
report it. What should you do first?
A) Document the medication as a protocol deviation
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B) Withdraw the subject from the study immediately
C) Ask the subject to stop taking the medication going forward
D) Contact the principal investigator to determine if the subject can continue
Correct Answer: D. The PI must evaluate whether the prohibited medication affects subject
safety or data integrity; the CRC should not make unilateral decisions about subject
continuation.*
3. An investigator receives an unsolicited adverse event report for a subject who is no longer
participating in the study. The event occurred two months after the subject completed the final
study visit. What is the appropriate reporting timeline?
A) No reporting is required since the subject completed the study
B) Report within 24 hours if it is serious and related
C) Report at the next scheduled safety update
D) Report only if the event requires hospitalization
Correct Answer: B. Serious adverse events that are possibly related to the investigational
product must be reported even after study completion if they occur within the predefined follow-
up period, typically within 24 hours for serious unexpected suspected adverse reactions.*
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4. A subject arrives for a study visit and appears confused about the informed consent process.
The subject signed the consent form two weeks ago but now asks, “What exactly am I agreeing
to?” What is the CRC’s best response?
A) Remind the subject that they already signed the consent form
B) Re-explain the key elements of the study and assess understanding
C) Have the subject sign a new consent form
D) Ask the PI to speak with the subject
Correct Answer: B. Informed consent is an ongoing process; the CRC should re-explain the study,
assess comprehension, and document the conversation rather than assuming prior consent
remains valid.*
5. The study drug is stored in a refrigerator with a temperature range of 2–8°C. During morning
temperature checks, you find the log shows the refrigerator reached 10°C overnight. What is the
most appropriate immediate action?
A) Move all study drug to another refrigerator
B) Quarantine the affected drug and notify the sponsor
C) Continue using the drug since the excursion was minimal
D) Adjust the refrigerator thermostat and continue monitoring
Correct Answer: B. Any temperature excursion outside the labeled storage range requires
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quarantine of the affected product, notification of the sponsor or manufacturer, and evaluation
of stability impact before determining product usability.*
6. A subject reports mild nausea after the first dose of investigational product. The investigator
determines it is not serious and not related to the study drug. How should the CRC document
this?
A) As an adverse event with attribution of “not related”
B) As a serious adverse event due to the symptom
C) As a protocol deviation
D) It does not need to be documented since it is not related
Correct Answer: A. All adverse events, regardless of attribution, must be documented in the
source documents and case report forms; the investigator’s assessment of causality must be
recorded.*
7. During a monitoring visit, the CRA requests access to subject records that are stored in a
locked cabinet in the CRC’s office. The CRC is not present but has the only key. What should the
CRC do?
A) Give the key to the CRA so they can access the records
B) Arrange a time to be present when the CRA reviews the records
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