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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?

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

Statistical analysis will be performed to:

3. While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites.

What is an appropriate FIRST action for the sponsor to take?

4. The PI should ensure that source data is:

5. A clinical trial is conducted to measure the effectiveness of music therapy to reduce anxiety in intensive care unit patients. Patients are randomly assigned to receive headphones with music of their choice or headphones with white noise.

The group receiving the white noise headphones is considered which type of control group?

6. 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?

7. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

8. Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

9. A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP.

Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

10. The IRB/IEC has decided to not approve a clinical trial.

Who must they notify in writing?

11. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded.

Which of the following study documentation practices was neglected?

12. Which of the following activities is the MOST efficient way of overseeing a CRO’s management during a clinical trial?

13. In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

14. At a close-out visit, which document should be retained only at the site?

15. Who is responsible for the ongoing safety evaluation of the IP?

16. Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

17. While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.

Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

18. All site financial matters pertaining to a trial are listed in what document?

19. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

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

21. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial.

The CRC is required to utilize which of the following in the consent process?

22. Who on the local site research study team is accountable for the unblinding documentation of IP?

23. 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:

24. AEs that occur between study visits of a clinical trial should be evaluated by the:

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

26. 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?

27. Source data/documentation should be:

28. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications.

What should be the investigator's IMMEDIATE response?

29. A study subject inadvertently disposed of IP medication bottles. The site should report this to the:

30. The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:

31. A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot.

How should this be reported by the site?

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

33. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA.

What is the purpose of this CAPA?

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

35. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

36. All of the following are examples of what monitors review EXCEPT:

37. A serious unexpected ADR is one:

38. The investigator/institution should permit:

39. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects.

What are the NEXT steps the investigator should take?

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

41. A root cause analysis should be:

42. Which of the following elements of the Informed Consent are NOT required?

43. An impartial witness should be present during the entire informed consent discussion when:

44. A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.

Which of the following is an appropriate title for this study?

45. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

46. Who ensures information regarding payments to subjects is documented in a written consent form?

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

Which of the following statements is the MOST correct?

48. Who takes responsibility for initiating a clinical trial?

49. An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results.

Who should perform a root cause analysis and implement appropriate corrective and preventive actions?

50. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the 1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP.

What is the participant’s overall compliance?