QUIZ 2025 NEWEST ACRP-CP: ACRP CERTIFIED PROFESSIONAL EXAM TRAINING KIT

Quiz 2025 Newest ACRP-CP: ACRP Certified Professional Exam Training Kit

Quiz 2025 Newest ACRP-CP: ACRP Certified Professional Exam Training Kit

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ACRP Certified Professional Exam Sample Questions (Q101-Q106):

NEW QUESTION # 101
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* 3 participants were withdrawn due to noncompliance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?

  • A. 6 participants
  • B. 3 participants
  • C. 5 participants
  • D. 4 participants

Answer: B

Explanation:
Since the protocol specifies that participants withdrawn due to an Adverse Event (AE) should not bereplaced, only the participants withdrawn for noncompliance (3 in total) should be replaced. The participant who withdrew consent due to severe nausea (an AE) and the one who discontinued IP due to hospitalization should not be replaced.
GCP guidelines specify that replacement of subjects should follow the protocol criteria, particularly when AEs are involved.
"Participants withdrawn due to AEs should not be replaced if the protocol stipulates this condition, while noncompliant participants may be replaced." Objectives:
* Follow protocol guidelines for participant replacement.
* Ensure compliance with study criteria.


NEW QUESTION # 102
During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

  • A. Sponsor
  • B. PI
  • C. CRC
  • D. CRA

Answer: B

Explanation:
The Principal Investigator (PI) is responsible for ensuring that all equipment used in the clinical trial is properly maintained and serviced. If a monitor (CRA) identifies equipment that needs servicing, the PI must take immediate action to ensure the equipment is in working order to maintain the quality and integrity of the study data.
GCP guidelines emphasize the PI's responsibility to ensure that all equipment used in the study is functional, properly calibrated, and serviced as needed.
"The PI is responsible for maintaining the functionality and calibration of study-related equipment to ensure accurate data collection." Objectives:
Maintain equipment functionality to ensure data accuracy.
Ensure proper maintenance as part of site management.


NEW QUESTION # 103
The composition of an IDMC/DSMB should include which one of the following?

  • A. A sponsor representative who is knowledgeable about the study's unblinded information
  • B. A lead PI for the study
  • C. A clinical scientist who is knowledgeable in the appropriate discipline
  • D. A member from the IRB/IEC

Answer: C

Explanation:
An Independent Data Monitoring Committee (IDMC) or Data and Safety Monitoring Board (DSMB) should include clinical scientists who are knowledgeable in the relevant medical and scientific areas. Their role is to objectively assess the ongoing safety data and efficacy of the investigational product, ensuring that participants' safety is not compromised.
GCP guidelines emphasize the need for experienced clinical scientists on IDMC/DSMBs to ensure that safety data is interpreted accurately and professionally.
"IDMC/DSMB should comprise independent experts, including clinical scientists, who have the expertise to evaluate safety and efficacy data objectively." Objectives:
* Ensure impartial evaluation of safety data.
* Maintain scientific integrity in monitoring clinical trials.


NEW QUESTION # 104
At a close-out visit, which document should be retained only at the site?

  • A. Final trial close-out monitoring report
  • B. Subject identification code list
  • C. IP accountability
  • D. Treatment allocation

Answer: B

Explanation:
The subject identification code list, which links the participant's unique code to their personal information, must be retained only at the site. This list ensures confidentiality and is necessary for identifying participants during follow-up. It is not shared with the sponsor to protect participant privacy.
GCP guidelines mandate that the subject identification code list remains at the site to ensure confidentiality and compliance with data protection regulations.
"The subject identification code list must be securely stored at the site to maintain participant confidentiality." Objectives:
* Safeguard participant confidentiality.
* Maintain compliance with data protection policies.


NEW QUESTION # 105
While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

  • A. Locate a translator and have them work with the person.
  • B. Have the Principal Investigator consent the person.
  • C. Get an impartial witness involved in consenting this person.
  • D. There are no circumstances under which this person can be enrolled.

Answer: C

Explanation:
When a participant cannot read, an impartial witness must be present during the consent process. The witness ensures that the information is accurately presented and that the subject's consent is truly informed. The witness must sign the consent form to attest that the subject understands the information.
GCP guidelines require the use of an impartial witness during the informed consent process for individuals who are illiterate or visually impaired.
"Informed consent must involve an impartial witness when the subject cannot read, ensuring the consent process is conducted ethically." Objectives:
* Maintain ethical standards during consent.
* Protect the rights of participants with literacy challenges.


NEW QUESTION # 106
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