Training ACRP-CP For Exam, ACRP-CP Reliable Dump
Training ACRP-CP For Exam, ACRP-CP Reliable Dump
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ACRP Certified Professional Exam Sample Questions (Q69-Q74):
NEW QUESTION # 69
A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:
- A. PRO.
- B. Source document.
- C. CRF.
- D. Worksheet.
Answer: C
Explanation:
A Case Report Form (CRF) is a tool used in clinical trials to collect data as specified by the protocol. It is a printed, optical, or electronic document designed to record all protocol-required information for each trial subject. CRFs are crucial for ensuring that the data collected during the trial is accurate, complete, and consistent with the protocol.
This answer follows GCP guidelines, which describe CRFs as essential documents for capturing and transmitting study data to the sponsor.
"A Case Report Form (CRF) is a printed, optical, or electronic document specifically designed to record all protocol-required information to be reported to the sponsor on each trial subject." Objectives:
* Understand the role of CRFs in clinical trials.
* Ensure accurate and complete data collection.
NEW QUESTION # 70
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?
- A. Subject
- B. CRO
- C. Sponsor
- D. PI
Answer: C
Explanation:
The sponsor is responsible for defining the criteria and procedures for subject withdrawal or discontinuation of consent. This includes specifying how data already collected will be handled and whether any follow-up is required. The procedures must be clearly outlined in the study protocol and communicated to the research team.
This answer follows GCP guidelines, which state that the sponsor must ensure that procedures for subject withdrawal are clearly defined and documented.
"The sponsor is responsible for defining procedures to be followed if a subject discontinues participation or withdraws consent, including handling of data collected prior to withdrawal." Objectives:
* Ensure transparent procedures for participant withdrawal.
* Maintain data integrity while respecting participant autonomy.
NEW QUESTION # 71
The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?
- A. Time to occurrence of symptoms of the disease
- B. Occurrence of known side effects of the IP
- C. Impact of an approved vaccine against the disease
- D. Use of concomitant medications to treat the symptoms
Answer: A
Explanation:
In a clinical trial aimed at assessing whether an IP prevents disease recurrence, the primary endpoint would typically be the "time to occurrence of symptoms" indicating a relapse or recurrence. This endpoint directly measures the IP's effectiveness in prolonging the symptom-free period.
This answer follows the GCP guideline, which states that primary endpoints should directly reflect the trial's objectives, particularly when evaluating recurrence prevention.
"In trials evaluating recurrence prevention, the primary endpoint should measure the time until recurrence of the target symptoms or condition." Objectives:
* Assess the efficacy of IP in preventing disease recurrence.
* Accurately measure the time to recurrence as a primary endpoint.
NEW QUESTION # 72
A root cause analysis should be:
- A. Specific to a clinical trial.
- B. Validated before use in a CAPA.
- C. Written by the investigator.
- D. Focused on issues of non-compliance.
Answer: D
Explanation:
Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non- compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non- compliance ensures that the study adheres to GCP and regulatory requirements.
GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.
"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively." Objectives:
* Address non-compliance systematically.
* Develop effective CAPA plans.
NEW QUESTION # 73
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. 3 participants
- B. 5 participants
- C. 6 participants
- D. 4 participants
Answer: A
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 # 74
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