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ACRP CCRC EXAM PREP QUESTIONS TEST BANK. 300 QUESTIONS WITH CORRECT ANSWERS. LATEST 2025
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ACRP CCRC EXAM PREP QUESTIONS TEST BANK. 300 QUESTIONS WITH CORRECT ANSWERS. LATEST 2025
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ACRP CCRC Exam Prep QuestionsStudy online at https://quizlet.com/_fissv4
ACRP CCRC EXAM PREP QUESTIONS TEST BANK. 300 QUESTIONS WITH
CORRECT ANSWERS. LATEST 2025
1. What are expected or possible consequences of over-estimation of recruitment
potential?: - The trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed - The study
will not have sufficient data within the required timeframe and will be stopped
because of lack of budget
2. What should be the first consideration when conducting a clinical trial?:
Subject welfare
3. When is the investigator allowed to deviate from the protocol?: When there is
an immediate hazard to a patient.
4. If the investigator wanted to deviate from the protocol for an immediate
hazard to a patient, according to ICH E6 guidelines who world they need to report
the deviation and rationale to, if appropriate?: - The Sponsor - IRB/IEC
- Regulatory Authorities
5. Which conditions should be fulfilled when enrolling a subject into your trial?:
- Subject meets all inclusion criteria - Subject has given written informed consent
6. You've been delegated to handle the storage and inventory of IP. The study
drug must be stored below 25C/77F. On a summer Monday morning you discover
that the temperature recording machine in the storage room has failed so you doin't
know what the temperature has been over the weekend. You check the current
temperature; it's 24C/75F. What should you do?: - Contact the Sponsor, explain what
happened and ask for instructions - Set up a site staff meeting to conduct a root cause
analysis
7. A protocol amendment was issued for a trial. Your site received IRB approval
for the amendment and wants to implement the increase in PO dose for your trial
subjects as identified in the amendment trial subjects. As delegated consenting
duties you must re-consent trial subjects before being able to administer the
adjusted dose. You decide to only re-consent trial subjects who are still taking the
IP and not from the subjects woh already completed their drug intake period. Is this
allowed according the E6 Guideline for GCP?: No, these subjects are still enrolled in
the trial and therefore need to be updated on any changes to the protocol.
8. A trial subject informs you she no longer wants to participant in the trial.
What should your course of action be?: You ask if the patient wishes to share the
reason why she wants to leave the trial. If not, you exclude the subject from the trial
immediately.
9. A patient cannot recall the name of the heart condition medication he took a
few years ago. This is important information for deciding whether the patient may
, ACRP CCRC Exam Prep Questions
Study online at https://quizlet.com/_fissv4
be enrolled in a clinical trial (IC/EC). What's your best course of action?: You
attempt to retrieve the patients medical history by contacting previous caregivers and you
wait for additional information before enrollment.
10. Who has ultimate trial responsibility for each subject?: The principle
investigator.
11. A trial subject suffers from severe repeat headaches. Should this adverse
event be reported to the IRB?: No
12. What statements are true concerning an adverse drug reaction?: - All noxious
and unintended responses to a medicinal product related to any dose should be
considered as an ADR
- An ADR suggests a relationship to trail medication
- All ADRs must be documented
13. What Adverse Events (AEs) are Serious Adverse Events (SAEs)?: - Any AE that
results in death
- Any AE that results in inpatient hospitalization
- Any AE that is a congenital anomaly
14. During a study visit a patient tells the investigator that she visited an
emergency room and received intensive treatment for allergic bronchospasm. Since
the patient was in the emergency room for only three hours, the investigator did not
assess the event as serious. Is this a correct assessment?: No, this would be a
medically important event and should be considered serious
15. What data points minimally need to be reported by the site when reporting an
SAE, so that the sponsor can process the event?: Identification of event, product, and
trial subject
16. During a visit with investigator, a subject reported feeling heart palpitations
for a brief period of time during the previous evening. The heart palpitations
resolved without reoccurrence. The investigator considered these symptoms to be
unrelated to study drug. The next day, the subject told a fellow student that he felt
tired and was planning on taking a nap. Later, the subject was found dead. A
preliminary report from the medical examiner indicated the subject died of
pulmonary embolism. What should your next course of action be?: - Record these
events in case report form
- Immediately notify sponsor about serious adverse events
17. When asked by a regulatory body why they received SAE related information on
12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason
being they received the trial related SAE information from the investigator in
12/2013. Is the sponsor correct in only holding the investigator accountable for their
late reporting?: No, the sponsor should support the conduct QC activities with the sites
to help them ensure timely SAE reporting.
, . CCRC Exam Prep Questions
ACRP
Study online at https://quizlet.com/_fissv4
18 A trial subject in a cardiology trial is admitted to hospital with heart attack. The
investigator considers this event possibly related to the study drug even though this
is not listed in the IB as a potential adverse reaction. What would the investigator
report this event to the sponsor as?: An unexpected, serious adverse event
19. A 22y/o male was entered into a clinical study for treatment of schizophrenia
The study drug was administered orally, BID. One week later, the subject visited
the investigator complaining of sever sore throat. The IB lists this as an occurrence
reported by 1% of subjects receiving drug. How should this severe throat be
classified?: - An adverse event
- An adverse drug reaction
20. In regards to AE and ADR reporting, what statements are true?: - All ADRs are
AEs but not all AEs are ADRs
- Worsening in pre-existing medical conditions is an AE
-Preplanned hospitalization is usually not an SAE
21. What determines the causality of an adverse event?: The investigator
22. Which term best describes the cyclical process that involves the Plan, Do,
Check, Act activities?: Quality improvement
23. Which term best describes an independent assessment of completed work to
ensure it will meet applicable quality standards?: Quality assurance
24. Which term best describes the activities done to ensure quality output?: Quality
control
25. Which term requires structure and a definition of acceptable standards of
performance?: Quality planning
26. Which is represented in ALCOA-C?: Attributable
27. What does CAPA stand for?: Corrective and Preventive Action
28. When not completed correctly, which is a major contributing factor to an
ineffective CAPA plan?: Root cause analysis
29. What are the cyclical activities performed a part of quality improvement?: Plan,
Do, Check, Act
30. What is used to determine root causes?: - Fishbone diagram
- Process flow charts
- The 5 Whys
31. What are fishbone diagrams, process flow charts, and the 5 whys used for
determining?: Root causes
32. What is the key difference between quality improvement and quality
assurance activities?: Can be performed by persons involved in doing the work.
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