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ACRP CCRC EXAM PREP QUESTIONS
AND VERIFIED ANSWERS
Question :What are expected or possible consequences of
over-estimation of recruitment potential?
Correct answer:
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
Question :What should be the first consideration when
conducting a clinical trial?
Correct answer:Subject welfare
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Question :When is the investigator allowed to deviate from
the protocol?
Correct answer:When there is an immediate hazard to a
patient.
Question :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?
Correct answer:
The Sponsor
IRB/IEC
Regulatory Authorities
Question :Which conditions should be fulfilled when
enrolling a subject into your trial?
Correct answer:
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Subject meets all inclusion criteria
Subject has given written informed consent
Question :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?
Correct answer:
Contact the Sponsor, explain what happened and ask for instructions
Set up a site staff meeting to conduct a root cause analysis
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Question :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?
Correct answer:No, these subjects are still enrolled in the trial
and therefore need to be updated on any changes to the protocol.
Question :A trial subject informs you she no longer wants to
participant in the trial. What should your course of action be?
Correct answer: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.
Question :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