Prepare ACRP-CP Exam with Using ACRP-CP Dump Questions

1. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.

The status of the enrolled participants is as follows:

3 participants were withdrawn due to noncompliance

1 participant withdrew consent after experiencing severe nausea

1 participant had to discontinue IP for an unscheduled hospitalization

1 participant who is not returning for visits

2 participants completed the 6 months of treatment

4 participants currently on IP

How many participants should be replaced?

2. A deferred consent can take place in which of the following situations?

3. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

4. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening.

What should happen FIRST?

5. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion.

Which document describes how the transfer will occur?

6. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial.

How should they proceed?

7. One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

8. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

9. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

10. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

11. In a quality management system, in which category do risk reduction activities belong?

12. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

13. The PI should ensure that source data is:

14. Who should vote during the IRB/IEC review and discussion process?

15. A new device trial is being considered. Before committing to participate in the trial, what is the MOST important item the PI needs to evaluate?

16. A study protocol must contain which of the following elements?

17. The composition of an IDMC/DSMB should include which one of the following?

18. The coding system for a double-blind clinical trial is accessible by the:

19. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant.

Which of the following should be done FIRST?

20. 1.An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor.

Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

21. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

22. A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV.

The site cannot begin enrolling subjects until:

23. Which one of the following is a primary objective of a Phase III study of a new IP?

24. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

25. What is a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

26. Which of the following statements is TRUE about an EDC system?

27. Who determines the age of assent for pediatric studies?

28. Who is responsible for submitting a protocol amendment to the IRB/IEC?

29. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

30. A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels.

Statistical analysis will be performed to:

31. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

32. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

33. What would a sponsor use to implement and maintain quality in a study?

34. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial.

Who is responsible for revising the IB with this updated information?

35. The sponsor should supply a PI with the IP after:

36. A sponsor wants to transfer duties to a CRO.

Which of the following statements is the MOST correct?

37. Which document confirms the PI’s agreement to permit auditing at the study site?

38. The inclusion and exclusion criteria are in place so all subjects are: