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[General] CCRP復習過去問、CCRP試験過去問

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【General】 CCRP復習過去問、CCRP試験過去問

Posted at 16 hour before      View：6 | Replies：0        Print      Only Author   [Copy Link] 1#
ちなみに、Jpexam CCRPの一部をクラウドストレージからダウンロードできます：https://drive.google.com/open?id=10nHI1MY1ZyjDxv7zzMJM0OiWzFpayxPJ
Jpexamは、認定資格を取得し、社内でより重要な地位を獲得することで、希望するより高い給与を達成するための最良かつ最速の方法を提供します。低品質のCCRP試験資料が会社に不信感をもたらす可能性があるという信念があるためです。 CCRP学習の質問は、メリットに満ちた否定できない優れた製品です。したがって、CCRP試験の資料は、私たち自身のイメージを高めることができます。一方、当社のCCRP試験の教材は、複雑な知識の本質をつかむのに役立つ非常に効果的です。
SOCRA CCRP 認定試験の出題範囲：
トピック出題範囲
トピック 1
  • Research Study Start-Up: This section of the exam measures the skills of Clinical Research Coordinators and covers the initial planning and setup of a clinical trial. It involves coordinating the development of the study protocol, ensuring it considers ethical guidelines and regulatory pathways like IND or IDE. It also includes creating essential study documents like informed consent forms and case report forms. The domain covers obtaining necessary approvals from stakeholders like the IRB and sponsor, selecting study sites, training staff, and ensuring the study's compliance with various laws. Additionally, it involves obtaining the research product and preparing all necessary tools and documentation for the study's commencement.|Research Study Implementation: This section of the exam measures the skills of Clinical Research Associates and covers the active management and execution of the clinical trial. It focuses on following the study protocol and standard operating procedures, managing the investigational product, and ensuring ongoing regulatory compliance. The domain includes identifying, documenting, and reporting any study anomalies such as adverse events or protocol deviations. It also involves managing subject recruitment, consent, and retention, as well as maintaining all study records and essential documents. Furthermore, it covers communicating with all study stakeholders and participating in study audits to ensure quality and adherence to regulations.
トピック 2
  • Research Study Closure: This section of the exam measures the skills of Clinical Research Coordinators and covers the activities required to properly conclude a clinical trial. It involves participating in the study closeout visit to verify documentation and account for the investigational product. The domain also includes developing and submitting final closure reports to the IRB, study sponsor, regulatory authorities, and clinicaltrials.gov. Finally, it covers the procedures for archiving study records.

更新するCCRP復習過去問試験-試験の準備方法-100％合格率のCCRP試験過去問あなたはSOCRAのCCRP試験への努力を通して満足的な結果を得られているのは我々Jpexamの希望です。信じられないなら、弊社のデモをやってみて、SOCRAのCCRP試験問題集を体験することができます。試して我々専門家たちの真面目さを感じられています。SOCRAのCCRP試験のほかの試験に参加するつもりでしたら、あなたも弊社のJpexamでふさわしいソフトを探すことができます。あなたは満足できると信じています。
SOCRA Certified Clinical Research Professional (CCRP) 認定 CCRP 試験問題 (Q29-Q34):質問 # 29
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?
  • A. The sponsor failed to submit an accurate annual report of the study to the FDA
  • B. The reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study
  • C. The FDA issued a clinical hold, and 30 days have elapsed
  • D. An investigator failed to submit safety reports to the FDA
正解：C
解説：
The FDA has authority to imposeclinical holds and terminationson IND studies when subject safety is at risk.
* 21 CFR 312.44(b)(1):"The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury."
* 21 CFR 312.42(e):"If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND." Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination.
IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).
Thus, the correct answer isD (The FDA issued a clinical hold, and 30 days have elapsed).
References:
21 CFR 312.44(b)(1) (Termination of an IND).
21 CFR 312.42(e) (Clinical hold procedures).

質問 # 30
A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?
  • A. $5,000
  • B. Any amount
  • C. >$25,000
  • D. $10,000
正解：D
解説：
* 21 CFR 54.2(f) & 54.4(a):Requires disclosure of "significant payments of other sorts" (SPOOS) that exceed$25,000or equity interests exceeding$50,000.
* However,honoraria or consulting exceeding $10,000 annuallyalso trigger disclosure.
Thus, the reporting threshold is$10,000.
References:21 CFR 54.2(f), 54.4(a).

質問 # 31
In accordance with the CFR, a sponsor must submit a protocol amendment to the FDA for which of the following?
  • A. A significant change in an investigator's financial interest in the investigational product
  • B. A change in the manufacturing site for the investigational product
  • C. The addition of a new test that is intended to improve monitoring the subject for an adverse effect
  • D. The addition of a sub-investigator with the scientific training and expertise to conduct the investigation
正解：B
解説：
The U.S. Code of Federal Regulations (CFR) specifies when sponsors must notify FDA of changes to investigational drug studies under 21 CFR 312.30. A protocol amendment is required if there is:
A change to the protocol (e.g., objectives, design, subject population, dosing, or procedures).
The addition of a new investigator.
A change in the chemistry, manufacturing, or controls (CMC) that could significantly affect product quality or safety.
Among the listed options, a change in the manufacturing site (D) directly falls under significant manufacturing changes, requiring FDA submission. Changes in investigator financial interests (B) are covered under 21 CFR 54 and reported separately, not as protocol amendments. Addition of a sub-investigator (C) does not require a formal amendment, only site-level documentation and delegation log update. Addition of a monitoring test (A) may affect the protocol, but not necessarily mandate an amendment unless it changes objectives or subject safety endpoints.
Therefore, the correct answer is D. This ensures FDA oversight of product safety, efficacy, and compliance with CMC standards before investigational use.
References:
21 CFR 312.30 (Protocol amendments).
21 CFR 312.23(a)(7) (Chemistry, manufacturing, and controls information).

質問 # 32
According to the CFR, which of the following is a complete and accurate list of the signatures required on the short form consent document?
  • A. The subject or else the subject's legally authorized representative
  • B. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee; the witness
  • C. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee
  • D. The subject or else the subject's legally authorized representative; the witness
正解：D
解説：
Theshort form consent processis permitted when the subject is presented with a brief written statement that they were informed of the study, supplemented by an oral presentation.
* 21 CFR 50.27(b)(2):Requires the short form to be signed by the subject (or legally authorized representative)and a witness.
* The witness ensures that oral consent was properly conveyed and understood.
* The person obtaining consent must sign aseparate written summary, but not the short form itself.
Thus, the accurate answer isA: subject (or LAR) + witness.
References:
21 CFR 50.27(b)(2).

質問 # 33
In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:
  • A. Customize access rights
  • B. Generate audit trails
  • C. Maintain accurate records throughout retention
  • D. Print a complete paper copy
正解：D
解説：
* 21 CFR 11.10:Requires validation, audit trails, secure access, but does not mandate printing capability.
Thus, (D) is the exception.
References:21 CFR 11.10.

質問 # 34
......
我々はCCRP問題集の英語版と日本語版を開発しています。英語版と日本語版の内容が同じですが、言葉だけ違います。CCRP問題集に英語試験と日本語試験を準備する受験者たちは気楽に試験に合格することができます。それに、我々のSOCRAのCCRP日本語版問題集を購入するなら、英語版をおまけにさし上げます。
CCRP試験過去問: https://www.jpexam.com/CCRP_exam.html
ちなみに、Jpexam CCRPの一部をクラウドストレージからダウンロードできます：https://drive.google.com/open?id=10nHI1MY1ZyjDxv7zzMJM0OiWzFpayxPJ
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