ACRP-CP無料問題集「ACRP Certified Professional」

質問 1

The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:

（A）Confirm subjects receive the appropriate reimbursement.

（B）Review the content for ethically or morally sensitive issues.

（C）Safeguard the rights, safety, and well-being of all potential subjects.

（D）Assure the ads do not impinge on confidentiality agreements.

正解：C 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 2

All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

（A）Assessing risk based on study impact.

（B）Controlling risk by setting thresholds of risk acceptability.

（C）Identifying potential study risks.

（D）Documenting all possible risk scenarios.

正解：D 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 3

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）Investigator

（B）Sponsor

（C）Health authority

（D）DSMB/IDMC

正解：B 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 4

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?

（A）Update the IB to add the risk of infection and submit to the sponsor for approval.

（B）Add the risk of infection to the ICF and submit to the IRB/IEC for review.

（C）Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.

（D）Discontinue current subjects from the study and monitor subjects for any anticipated safety events.

正解：C 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 5

The IB contains which of the following sections?

（A）Known pharmacokinetic effects

（B）Participant eligibility criteria

（C）Participant dosing schedule

（D）IP preparation instructions

正解：A 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 6

When assessing the monitoring needs for a study, sponsors should:

（A）Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.

（B）Permit PIs to select a monitor for their site as long as they are independent of the PI.

（C）Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.

（D）Use central monitoring instead of conducting physical monitoring visits at sites.

正解：C 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 7

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）Meet with the site staff to understand their workflows and to review retention strategies.

（B）Submit revised ICFs to the IRB/IEC with increased compensation for participants.

（C）Interview participants who have dropped out.

（D）Require participants to provide documented reason for withdrawal.

正解：A 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 8

A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

（A）Data & Safety Monitoring Plan

（B）Standard Operating Procedure

（C）Investigator's Brochure

（D）Clinical Monitoring Plan

正解：B 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 9

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

（A）7 calendar days

（B）15 calendar days

（C）30 calendar days

（D）8 calendar days

正解：B 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

質問 10

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）5 participants

（B）3 participants

（C）6 participants

（D）4 participants

正解：B 解答を投票する

解説: (JPNTest メンバーにのみ表示されます)

ACRP-CP 無料問題集「ACRP Certified Professional」

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