ACRP PRACTICE EXAM QUESTIONS

ACRP PRACTICE EXAM QUESTIONS

AND ANSWERS/ ACRP PRAC TICE

EXAM QUESTIONS AND ANSWERS

Question 1: 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 2: What should be the first consideration when

conducting a clinical trial?

CORRECT ANSWER: Subject welfare

Question 3: When is the investigator allowed to deviate from

the protocol?

CORRECT ANSWER: When there is an immediate hazard to

a patient.

Question 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?

CORRECT ANSWER: - The Sponsor

- IRB/IEC

• Regulatory Authorities

Question 5: Which conditions should be fulfilled when

enrolling a subject into your trial?

CORRECT ANSWER: - Subject meets all inclusion criteria

• Subject has given written informed consent

Question 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?

CORRECT ANSWER: - Contact the Sponsor, explain what

happened and ask for instructions

• Set up a site staff meeting to conduct a root cause analysis

Question 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?

CORRECT ANSWER: No, these subjects are still enrolled in

the trial and therefore need to be updated on any changes to the protocol.

Question 8: 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 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 be enrolled in a clinical trial (IC/EC). What's your best course of action?

CORRECT ANSWER: You attempt to retrieve the patients

medical history by contacting previous caregivers and you wait for additional information before enrollment.

Question 10: Who has ultimate trial responsibility for each

subject?

CORRECT ANSWER: The principle investigator.

Question 11: A trial subject suffers from severe repeat

headaches. Should this adverse event be reported to the IRB?

CORRECT ANSWER: No

Question 12: What statements are true concerning an adverse

drug reaction?