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最新的 ACRP Certified Professional ACRP-CP 免費考試真題 (Q41-Q46):

問題 #41
Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A. Sponsor
B. PI
C. CRO
D. Subject

答案：A

解題說明：
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.

問題 #42
The PI should ensure that source data is:

A. Printed directly from the EMR.
B. Kept on site for a minimum of 2 years.
C. Accurately reflected in the eCRFs.
D. On worksheets that are provided by the sponsor.

答案：C

解題說明：
The PI is responsible for ensuring that the source data is accurately recorded in the electronic Case Report Forms (eCRFs). This accurate transposition of data is critical to maintaining data integrity and ensuring that the data collected at the site is consistent with the reported clinical outcomes.
GCP guidelines specify that source data should be accurate, legible, and directly reflected in the CRFs to maintain consistency and reliability.
"The PI must ensure that the source data are accurately and completely recorded in the eCRFs to maintain data integrity." Objectives:
* Ensure accurate data transposition from source to CRF.
* Maintain high standards of data quality and reliability.

問題 #43
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?

A. Require participants to provide documented reason for withdrawal.
B. Meet with the site staff to understand their workflows and to review retention strategies.
C. Submit revised ICFs to the IRB/IEC with increased compensation for participants.
D. Interview participants who have dropped out.

答案：B

解題說明：
Meeting with site staff to understand workflows and retention strategies is the most practical first step. By engaging with the team, the sponsor can identify potential issues affecting retention, such as site-related factors, participant burden, or protocol complexities. Addressing these issues collaboratively can improve retention without needing major protocol changes.
GCP guidelines recommend assessing and understanding site-specific challenges before making procedural changes or protocol amendments.
"Engaging with site staff to discuss retention issues helps identify root causes and develop practical solutions." Objectives:
* Improve participant retention through collaboration.
* Identify and address site-specific challenges.

問題 #44
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?

A. Health authority
B. Sponsor
C. Investigator
D. DSMB/IDMC

答案：B

解題說明：
The sponsor is responsible for updating the Investigator's Brochure (IB) with new information obtained from the completed Phase I trial. The IB must reflect the most current data on the drug's safety, efficacy, and dosing to support Phase II planning and execution.
According to GCP guidelines, the sponsor must ensure that the IB is updated regularly with relevant findings from ongoing and completed trials.
"The sponsor is responsible for ensuring that the Investigator's Brochure is updated with the latest safety and efficacy data before advancing to the next phase of the trial." Objectives:
* Keep the IB current and accurate.
* Inform investigators of the latest safety and efficacy data.

問題 #45
Source data/documentation should be:

A. Attributable, legible, correct, original, accurate, and complete.
B. Attributable, legible, correct, original, accurate, and clear.
C. Attributable, legible, contemporaneous, original, accurate, and clear.
D. Attributable, legible, contemporaneous, original, accurate, and complete.

答案：D

解題說明：
Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high- quality, reliable, and verifiable clinical trial records.
GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.
"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards." Objectives:
* Maintain data integrity and reliability.
* Adhere to best practices in clinical documentation.

問題 #46
......

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ACRP ACRP-CP題庫下載 - ACRP-CP考題資源

ACRP ACRP-CP考題資源 & ACRP-CP題庫資料

最新的 ACRP Certified Professional ACRP-CP 免費考試真題 (Q41-Q46):

100%通過的ACRP-CP題庫下載，最好的考試題庫幫助妳快速通過ACRP-CP考試

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