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ICH GCP FOR CCRC EXAM NEWEST 2026 ACTUAL
EXAM TEST BANK| ICH- GCP FOR CLINICAL
RESEARCH COORDINATORS (CCRC) EXAM PREP
WITH 550 REAL EXAM QUESTIONS AND CORRECT
VERIFIED ANSWERS/ GRADED A+ (MOST RECENT!!)
What is the role of the Clinical Research Coordinator (CRC) in case of
an SAE? - ANSWER - Ensure adequate medical care is provided and
report to the PI
What is the significance of the Investigator's Brochure in clinical trials?
- ANSWER - It contains information about the test article and expected
adverse events
What action should be taken if a subject is found to have hypertension
during screening? - ANSWER - Verify the blood pressure reading before
proceeding
What is the first step when a subject reports an adverse event? -
ANSWER - Assess the subject's condition
What is the importance of informed consent in clinical trials? -
ANSWER - It ensures that subjects understand the risks and benefits of
participation
What does ICH E6 4.11.1 state regarding SAEs? - ANSWER - All SAEs
should be reported immediately to the study sponsor and IRB/IEC
pg. 1
,2|Page
What should be done if a subject experiences an anaphylactic reaction? -
ANSWER - Inform the PI immediately
What is the correct action if a subject's event is related to the
investigational product? - ANSWER - Notify the sponsor
What is the protocol for reconsenting a subject? - ANSWER - Reconsent
the subject prior to administering further investigational product doses
What is the role of the sponsor in a clinical trial? - ANSWER - Oversee
the trial and ensure compliance with regulatory requirements
What should be done if a subject is unable to comply with trial
requirements? - ANSWER - Discontinue the subject from the trial
What is the significance of monitoring trial progress? - ANSWER - To
ensure safety and efficacy of the investigational product
What constitutes an unexpected adverse event? - ANSWER - An event
that does not appear in the Investigator's Brochure
Who should ensure adequate medical care for subjects in a clinical trial?
- ANSWER - The investigator
What should be assessed to determine the relatedness of adverse events
to a clinical trial? - ANSWER - The investigator should evaluate the
subject.
pg. 2
,3|Page
What is the best action for a CRC if a site has not received IRB/IEC
approval? - ANSWER - Review the research database and collate a list
of potential subjects.
What can the PI do regarding potential subjects before IRB/IEC
approval? - ANSWER - Research a retrospective database for potential
subjects.
Which of the following is NOT a regulatory document? - ANSWER -
Confidentiality agreement
What is the purpose of informed consent in clinical trials? - ANSWER -
It confirms a subject's willingness to participate.
What should be done first if the IRB/IEC approval letter is not obtained
before a CRA's initiation visit? - ANSWER - Call the IRB/IEC to check
the status of the letter.
When should the trough blood level for a once-daily drug be drawn? -
ANSWER - Just before the administration of the next dose.
What should the CRC do if 10 of 30 subjects recorded low temperature
readings? - ANSWER - The sponsor is responsible for maintaining
quality assurance and control.
What should the CRC do if the PI will be out of the country during a
close-out visit? - ANSWER - Reschedule the visit.
pg. 3
, 4|Page
What is required for a close-out visit according to sponsor SOPs? -
ANSWER - The PI must be present.
What should the CRC do if the CRA's final monitoring visit conflicts
with the PI's schedule? - ANSWER - Reschedule the visit.
What documents should the CRC prepare for a close-out visit? -
ANSWER - Treatment decoding documentation, drug accountability log,
subject identification code list, documentation of IP destruction, and
final report to the IRB/IEC.
What should be removed from the materials sent to the sponsor during a
close-out visit? - ANSWER - Subject identification code list
What should be removed from the material sent to the sponsor? -
ANSWER - The drug accountability log.
What is the correct documentation regarding the destruction of
investigational product (IP)? - ANSWER - Documentation of the
destruction is kept at the site and with the sponsor.
What should a CRC ask subjects stabilized on medications? - ANSWER
- When was the last time your medication dose changed.
How long will it take to fulfill enrollment for a trial with 24 subjects if
50% qualify? - ANSWER - 6 weeks.
pg. 4
ICH GCP FOR CCRC EXAM NEWEST 2026 ACTUAL
EXAM TEST BANK| ICH- GCP FOR CLINICAL
RESEARCH COORDINATORS (CCRC) EXAM PREP
WITH 550 REAL EXAM QUESTIONS AND CORRECT
VERIFIED ANSWERS/ GRADED A+ (MOST RECENT!!)
What is the role of the Clinical Research Coordinator (CRC) in case of
an SAE? - ANSWER - Ensure adequate medical care is provided and
report to the PI
What is the significance of the Investigator's Brochure in clinical trials?
- ANSWER - It contains information about the test article and expected
adverse events
What action should be taken if a subject is found to have hypertension
during screening? - ANSWER - Verify the blood pressure reading before
proceeding
What is the first step when a subject reports an adverse event? -
ANSWER - Assess the subject's condition
What is the importance of informed consent in clinical trials? -
ANSWER - It ensures that subjects understand the risks and benefits of
participation
What does ICH E6 4.11.1 state regarding SAEs? - ANSWER - All SAEs
should be reported immediately to the study sponsor and IRB/IEC
pg. 1
,2|Page
What should be done if a subject experiences an anaphylactic reaction? -
ANSWER - Inform the PI immediately
What is the correct action if a subject's event is related to the
investigational product? - ANSWER - Notify the sponsor
What is the protocol for reconsenting a subject? - ANSWER - Reconsent
the subject prior to administering further investigational product doses
What is the role of the sponsor in a clinical trial? - ANSWER - Oversee
the trial and ensure compliance with regulatory requirements
What should be done if a subject is unable to comply with trial
requirements? - ANSWER - Discontinue the subject from the trial
What is the significance of monitoring trial progress? - ANSWER - To
ensure safety and efficacy of the investigational product
What constitutes an unexpected adverse event? - ANSWER - An event
that does not appear in the Investigator's Brochure
Who should ensure adequate medical care for subjects in a clinical trial?
- ANSWER - The investigator
What should be assessed to determine the relatedness of adverse events
to a clinical trial? - ANSWER - The investigator should evaluate the
subject.
pg. 2
,3|Page
What is the best action for a CRC if a site has not received IRB/IEC
approval? - ANSWER - Review the research database and collate a list
of potential subjects.
What can the PI do regarding potential subjects before IRB/IEC
approval? - ANSWER - Research a retrospective database for potential
subjects.
Which of the following is NOT a regulatory document? - ANSWER -
Confidentiality agreement
What is the purpose of informed consent in clinical trials? - ANSWER -
It confirms a subject's willingness to participate.
What should be done first if the IRB/IEC approval letter is not obtained
before a CRA's initiation visit? - ANSWER - Call the IRB/IEC to check
the status of the letter.
When should the trough blood level for a once-daily drug be drawn? -
ANSWER - Just before the administration of the next dose.
What should the CRC do if 10 of 30 subjects recorded low temperature
readings? - ANSWER - The sponsor is responsible for maintaining
quality assurance and control.
What should the CRC do if the PI will be out of the country during a
close-out visit? - ANSWER - Reschedule the visit.
pg. 3
, 4|Page
What is required for a close-out visit according to sponsor SOPs? -
ANSWER - The PI must be present.
What should the CRC do if the CRA's final monitoring visit conflicts
with the PI's schedule? - ANSWER - Reschedule the visit.
What documents should the CRC prepare for a close-out visit? -
ANSWER - Treatment decoding documentation, drug accountability log,
subject identification code list, documentation of IP destruction, and
final report to the IRB/IEC.
What should be removed from the materials sent to the sponsor during a
close-out visit? - ANSWER - Subject identification code list
What should be removed from the material sent to the sponsor? -
ANSWER - The drug accountability log.
What is the correct documentation regarding the destruction of
investigational product (IP)? - ANSWER - Documentation of the
destruction is kept at the site and with the sponsor.
What should a CRC ask subjects stabilized on medications? - ANSWER
- When was the last time your medication dose changed.
How long will it take to fulfill enrollment for a trial with 24 subjects if
50% qualify? - ANSWER - 6 weeks.
pg. 4
