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

質問 1

A deferred consent can take place in which of the following situations?

（A）In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.

（B）Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.

（C）In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.

（D）Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.

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 2

Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

（A）How willing are current patients to participate in a trial with potentially serious side effects?

（B）How does the risk of developing cancer compare to the anticipated side effects from the drug?

（C）How likely are patients at high risk of cancer going to develop cancer during the study?

（D）How effective is the drug at treating patients that have been previously diagnosed with cancer?

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 3

Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

（A）Protocol, informed consent, and clinical trial agreement

（B）Protocol, IB, and information about payments and compensation available to subjects

（C）IB, site coordinator CVs, and information about payments and compensation available to subjects

（D）Protocol, site coordinator CVs, and clinical trial agreement

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

Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

（A）Quarantine IP without registering in IWRS and request replacement from sponsor.

（B）Dispose of IP and request replacement from sponsor.

（C）Register IP in IWRS, quarantine and notify sponsor of the excursion.

（D）Register IP in IWRS and continue with subject allocation.

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

Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

（A）CRO

（B）Investigator

（C）Sponsor

（D）CRC

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 6

An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

（A）Investigators participating in the trial.

（B）Executive board members.

（C）Regulatory authority expert advisors.

（D）Independent qualified individuals.

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 7

Who must be blinded in a double-blind study in order to prevent bias?

（A）Pharmacist

（B）IRB/IEC

（C）Data entry staff

（D）Subject

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 8

Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

（A）Consult the IB.

（B）Report the AE to the sponsor.

（C）Administer rescue medication.

（D）Call the medical monitor.

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 9

Who determines the age of assent for pediatric studies?

（A）PI

（B）Sponsor

（C）IRB/IEC

（D）Parent

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 10

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）Audit

（B）Site qualification

（C）Inspection

（D）Routine monitoring

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)

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

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