ACRP-CP試験無料問題集（127題）「ACRP Certified Professional 認定」

出題：1

After the site qualification visit report has been finalized, it must be:

A. Stored in the sponsor's budgets and contracts file.

B. Kept in the CRO/sponsor's trial master file.

C. Included in the PI's regulatory file.

D. Sent to the IRB/IEC for review and approval.

正解：B 解答を投票する

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出題：2

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

A. Recording data on source documents at the time the data are collected during the conduct of the study.

B. Comparing source document data to other data recorded in the same study time period.

C. Allowing real-time access for data review in the eCRF.

D. Recording the date and time each data element is entered onto the source document.

正解：A 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：3

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?

A. Develop a monitoring plan

B. Conduct routine investigators' meetings

C. Draft a CAPA plan

D. Establish a DSMB/IDMC

正解：D 解答を投票する

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出題：4

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

A. Coordinator

B. Sponsor

C. Monitor

D. Investigator

正解：D 解答を投票する

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出題：5

What is a systematic and independent examination of trial-related activities and documents todetermine 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?

A. Routine monitoring

B. Audit

C. Inspection

D. Site qualification

正解：B 解答を投票する

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出題：6

The sponsor should supply a PI with the IP after:

A. Submission of documents to IRB/IEC and regulatory authority for review.

B. Approval of protocol by the sponsor.

C. Approval/favorable opinion from IRB/IEC and regulatory authority.

D. Approval of protocol by the PI.

正解：C 解答を投票する

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出題：7

The investigator/institution should permit:

A. Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).

B. Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

C. Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.

D. Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.

正解：D 解答を投票する

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出題：8

After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

A. Submit the diary to the sponsor for approval.

B. No approval is necessary: give the diary to each subject.

C. Submit the diary to the IRB/IEC for approval.

D. Submit the diary to the regulatory authority for approval.

正解：C 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

出題：9

Which statement does NOT represent a study monitor's responsibilities?

A. Report serious adverse events to the IRB/IEC.

B. Check the accuracy and completeness of case report forms with source documents.

C. Verify that the PI has adequate qualifications and resources to conduct the study.

D. Provide communication between the sponsor and the PI.

正解：A 解答を投票する

解説: (GoShiken メンバーにのみ表示されます)

ACRP-CP試験無料問題集「ACRP Certified Professional 認定」