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[General] CCRP認定試験 & CCRPシュミレーション問題集

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【General】 CCRP認定試験 & CCRPシュミレーション問題集

Posted at yesterday 15:20      View：11 | Replies：0        Print      Only Author   [Copy Link] 1#
BONUS！！！ Topexam CCRPダンプの一部を無料でダウンロード：https://drive.google.com/open?id=16t7kIkoAMrEU5HtYjdhUqihJ1Yn06EaI
今この競争社会では、専門の技術があったら大きく優位を占めることができます。IT業界では関連の認証を持っているのは知識や経験の一つ証明でございます。Topexamが提供した問題集を使用してIT業界の頂点の第一歩としてとても重要な地位になります。君の夢は1歩更に近くなります。資料を提供するだけでなく、SOCRAのCCRP試験も一年の無料アップデートになっています。
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.

権威のあるCCRP認定試験一回合格-ユニークなCCRPシュミレーション問題集信頼できるプロフェッショナルな試験CCRP学習ガイド教材を購入する場合は、正しいWebサイトにアクセスしてください。 Topexamは、専門的な実際のテスト問題の最新バージョンのみを提供します。お客様に安心してお買い物をお楽しみいただけます。私たちのCCRP試験問題の高い合格率はこの分野で有名です。そのため、何年も早く成長し、多くの古い顧客を抱えることができます。 CCRP試験の質問を選択すると、CCRP試験の準備に時間を費やす必要がなくなり、考えすぎになりません。
SOCRA Certified Clinical Research Professional (CCRP) 認定 CCRP 試験問題 (Q22-Q27):質問 # 22
A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?
  • A. A printout of the electronic medical record
  • B. The electronic medical record
  • C. A printout of the EDC record
  • D. The EDC record
正解：D
解説：
Source data areoriginal records where data are first recorded.
* ICH E6(R2) 1.51efines source data as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial." Since subjects directly enter responses into the EDC, theEDC record itself is the original source document.
EMRs (B, C) and printouts (D) are secondary records.
Correct answer:A (The EDC record).
References:
ICH E6(R2), §1.51 (Definition of source data).

質問 # 23
Which of the following is considered a source document?
  • A. The protocol
  • B. The subject instruction sheet
  • C. Standard operating procedures (SOPs)
  • D. Pharmacy dispensing records
正解：D
解説：
Source documentsare the original records where trial data are first recorded, from which Case Report Form (CRF) entries are verified.
* ICH E6(R2) 1.52efines source documents as "original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, pharmacy dispensing records, recorded data from automated instruments, etc.)."
* ICH E6(R2) 8.3.13:Requires maintenance of "source documents" to verify data integrity and allow monitoring/audits.
Pharmacy dispensing records (D) fit this definition, as they show initial data on investigational product dispensing and accountability. In contrast, subject instruction sheets (A) are communication tools, SOPs (B) are procedural guides, and the protocol (C) is a governing document, none of which qualify as original data records.
Therefore, the correct answer isD (Pharmacy dispensing records).
References:
ICH E6(R2), §1.52 (Definition of source documents).
ICH E6(R2), §8.3.13 (Source documents in essential documentation).

質問 # 24
A sponsor is permitted to charge for an investigational drug but must provide what documentation?
  • A. CMS approval letter
  • B. Orphan product evidence
  • C. IRB attestation of institutional cost burden
  • D. Evidence of potential clinical benefit and significant advantage
正解：D
解説：
* 21 CFR 312.8(b):Sponsors may charge for investigational drugs only if they demonstrate that the drug providespotential clinical benefitand asignificant advantageover existing therapy.
* FDA must approve charging requests.
References:21 CFR 312.8(b).

質問 # 25
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
  • A. Reviewing IRBs/IECs
  • B. OHRP
  • C. Site coordinator
  • D. Investigational pharmacies
正解：A
解説：
* 21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.
* Ensures subjects are protected and sites stop enrollment.
References:21 CFR 312.56(d).

質問 # 26
A sponsor became aware of a new serious adverse event related to a drug. Who must be notified in addition to FDA?
  • A. All investigational pharmacists
  • B. All IRBs/IECs of record
  • C. OHRP
  • D. All participating investigators
正解：D
解説：
* 21 CFR 312.32(c)(1)(ii):Sponsors must notifyall participating investigatorsof any serious and unexpected suspected adverse reactions.
* Investigators then inform IRBs and subjects as appropriate.
References:21 CFR 312.32(c)(1)(ii).

質問 # 27
......
異なる電子機器でCCRP試験問題を練習する場合。 APPバージョンのCCRPトレーニングブレインダンプは非常に便利です。さらに、CCRPトレーニング資料のオンライン版はオフライン状態でも機能します。 CCRP学習ガイドを購入すると、オフライン状態のときに試験を準備するためにCCRP学習教材を使用できます。 CCRP試験問題のオンライン版が気に入っていただけると思います。
CCRPシュミレーション問題集: https://www.topexam.jp/CCRP_shiken.html
さらに、Topexam CCRPダンプの一部が現在無料で提供されています：https://drive.google.com/open?id=16t7kIkoAMrEU5HtYjdhUqihJ1Yn06EaI
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