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ACRP CCRC Competency study guide Exam test questions with approved Answers 2024/2025
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ACRP CCRC Competency study guide Exam test questions with approved Answers 2024/2025 According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for all other serious, unexpected ADR's? - correct answer ≤ 15 calendar days. "As soon as possible, but no later th...

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  • October 4, 2024
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  • 2024/2025
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ACRP CCRC Competency study guide Exam
test questions with approved Answers
2024/2025

According to the ICH-E2A, what is the initial reporting timeline
required by the sponsor for all other serious, unexpected ADR's?
- correct answer ≤ 15 calendar days.


"As soon as possible, but no later than 15 calendar days after
first knowledge by the sponsor."


A subject in a Phase I oncology trial experiences nausea with
vomiting after IP infusion which results in an inpatient
hospitalization. Nausea with vomiting does not appear in the
Investigator's Brochure. The investigator should rate this event
as: - correct answer A. expected and serious.
B. expected and not serious.
C. unexpected and serious.
D. unexpected and not serious.


(C)


Which of the following documents are required to be present in
the investigator's trial files at the end of the trial? - correct
answer 1. subject enrollment logs


2. IP certificate of analysis

,3. sample of labels affixed to IP containers


4. investigator notification of new IP safety information


A. 1 and 3 only
B. 1 and 4 only
C. 2 and 3 only
D. 2 and 4 only


(B)


A clinical trial is being conducted to determine the safety and
tolerability of a new anti-emetic IP. The sponsor expects to enroll
20 subjects. This would be considered a: - correct answer A.
Phase I trial.
B. Phase II trial.
C. Phase III trial.
D. Phase IV trial


(A)


A subject has a history of dermatitis. During visit 2 of the trial,
the subject complained of a rash. The investigator interrupted
the use of the IP and the rash disappeared. At the next visit, the
IP was restarted. One day later, the rash reappeared. The
investigator discontinued the subject from the trial. The causality
can be determined as probably related to the IP based on: -
correct answer A. the placebo effect.

,B. a positive rechallenge.
C. insufficient information.
D. the history of dermatitis.


(B)


From the sponsor's initial receipt of information about an SAE
that is serious, unexpected, considered related to the use of the
drug but did not result in death and was not considered life-
threatening, how long does the sponsor have to notify the
regulatory authorities? - correct answer A. within 24 hours
B. within 7 calendar days
C. within 15 calendar days
D. within 30 calendar days


(C)


A CRC reports discovering records in the site's storage area from
a trial that closed 4 years ago. Based on the ICH Guidelines
regarding trial record retention, which of the following should
occur? - correct answer A. The sponsor will notify the site
after 2 years with record disposition information.
B. The site personnel will contact the IRB/IEC to request
permission to dispose of the records.
C. The site will forward the trial records to the regulatory
document manager of the CRO.
D. The sponsor will contact the site when record retention is no
longer required.

, (D)


Which of the following are conducted as part of a pre-trial visit? -
correct answer 1. Evaluate the qualifications of the
investigator and staff.


2. Confirm the availability of an acceptable monitoring plan.


3. Execute two copies of the clinical trial agreement.


4. Assess the storage location of IP.


A. 1 and 2 only
B. 1 and 4 only
C. 2 and 3 only
D. 3 and 4 only


(B)


During the trial close-out visit, the CRA is reviewing the
investigator's responsibility to retain source documents. Which of
the following would be considered a source document? - correct
answer 1. x-ray report


2. final monitoring log


3. sheet of paper where procedure results were recorded

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