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[General] 認定するCCDM勉強の資料試験-試験の準備方法-真実的なCCDM認定試験トレーリング

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【General】 認定するCCDM勉強の資料試験-試験の準備方法-真実的なCCDM認定試験トレーリング

Posted at 7 hour before      View：3 | Replies：0        Print      Only Author   [Copy Link] 1#
P.S. Tech4ExamがGoogle Driveで共有している無料かつ新しいCCDMダンプ：https://drive.google.com/open?id=1CgzL9kDDmP-weOOcbyljsZ52dJgzYLEu
CCDM試験問題はすべて、99％〜100％の高い合格率を持ち、有効です。 CCDM学習ガイドの非周期性を修正します。購入したものが最新かつ高品質のCCDM準備資料であることをご安心ください。 CCDM実践準備はお金に見合う価値があることを保証します。すべてのユーザーはCCDM試験ガイドの恩恵を受けます。試験に不合格になった場合、すぐに全額のダンプを返金します。余分なペニーはすべてその価値に値します。 CCDMテストの質問が最良の選択です。
SCDM CCDM 認定試験の出題範囲：
トピック出題範囲
トピック 1
  • レビュータスク: このセクションでは、データ マネージャーのスキルを測定し、プロトコル、CRF、データ テーブル、リスト、図、臨床試験レポート (CSR) をレビューして、一貫性、正確性、およびデータ処理の定義と規制要件との整合性を確認します。
トピック 2
  • データ処理タスク: このセクションでは、臨床システムアナリストのスキルを測定し、データライフサイクル全体にわたって品質、一貫性、適切な権限を維持しながら、研究データの処理、変換、統合、調整、コーディング、クエリ、更新、アーカイブ化に焦点を当てます。
トピック 3
  • テストタスク: このセクションでは、データ マネージャーのスキルを測定します。テスト計画の作成、テスト データの生成、検証およびユーザー受け入れテストの実行、およびシステムとプロセスが確実に仕様どおりに実行されるようにするための結果の文書化が含まれます。
トピック 4
  • 設計タスク: CCDM 試験のこのセクションでは、データ マネージャーのスキルを測定し、データ収集機器の設計と文書化、ワークフローとデータ フローの開発、データ要素、CRF フォーム、編集チェック、レポート、データベース構造の指定、追跡可能性と監査可能性の標準と手順の定義方法について学習します。
トピック 5
  • 調整とプロジェクト管理タスク: このドメインでは、データ管理ワークロード、ベンダーの選択、スケジュール、チーム間のコミュニケーション、プロジェクト タイムライン管理、リスク処理、メトリックの追跡、監査の準備の調整における臨床システム アナリストのスキルを評価します。

CCDM問題集、受験者たちの認可を得ているSCDM CCDM模擬試験Tech4Examは、魅力的なキャラクターで世界中の試験受験者を招きます。当社の専門家は彼らの卓越性に大きく貢献しました。したがって、試験をシミュレートするCCDMが最良であると率直に言うことができます。 CCDM学習教材のコンテンツを作成する取り組みは、学習ガイドの開発につながり、完成度を高めます。関心を集め、いくつかの難しい点を簡素化するために、当社の専門家は当社のCCDM学習資料を設計し、CCDM学習ガイドをよりよく理解できるように最善を尽くします。
SCDM Certified Clinical Data Manager 認定 CCDM 試験問題 (Q69-Q74):質問 # 69
A study has an expected enrollment period of one year but has subject recruitment issues. Twelve new sites are added toward the end of the expected enrollment period to help boost enrollment. What is the most likely impact on data flow?
  • A. The distribution of subjects selected for quality control will need to be stratified to allow for the twelve new sites.
  • B. The database set-up will need to be changed to allow for additional sites as they are added to the study.
  • C. Additional sites will likely have increased query rates since site training is occurring closer to study close.
  • D. A bolus of CRFs at the end of the study will result in the need to increase data entry and cleaning rates to meet existing timelines.
正解：D
解説：
Adding multiple new sites late in the enrollment period creates a concentrated influx of new data near the end of the study. These sites typically start enrolling patients later, resulting in a "bolus" of Case Report Forms (CRFs) that must be entered, validated, and cleaned within a shorter timeframe to meet database lock deadlines.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Project Management and Data Flow), late site activation compresses the timeline for data management tasks, necessitating increased resources for data entry, query management, and cleaning. Data management teams must anticipate this surge and plan accordingly-either by increasing staffing or revising timelines to prevent bottlenecks and maintain quality.
While option D (increased query rates) can occur, it is a secondary effect. The most direct and consistent impact is the surge in data volume requiring expedited processing near study end.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Project Management, Section 5.3 - Managing Changes in Site Activation and Data Flow ICH E6(R2) GCP, Section 5.1 - Quality Management and Oversight

質問 # 70
Which data are needed to monitor site variability in eligibility screening?
  • A. Number of subjects enrolled
  • B. Number of sites with low enrollment
  • C. Number of subjects screened and number of subjects enrolled
  • D. Number of sites with high enrollment
正解：C
解説：
To monitor site variability in eligibility screening, you must analyze the number of subjects screened versus the number of subjects enrolled at each site. This allows identification of sites that are over- or under-screening relative to their enrollment yield.
The GCDMP (Chapter: Data Quality Assurance and Metrics) emphasizes that screening-to-enrollment ratios are critical indicators of protocol compliance and data quality. Sites with unusually low conversion rates may have unclear understanding of inclusion/exclusion criteria, requiring targeted training or monitoring.
Other options (A, C, D) provide enrollment metrics but do not reveal screening efficiency or variability, which depend on both screening and enrollment data.
Thus, option B correctly identifies the data necessary for monitoring eligibility screening performance across sites.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Quality Assurance and Metrics, Section 5.4 - Site Performance Metrics ICH E6(R2) GCP, Section 5.18 - Monitoring and Site Oversight Requirements

質問 # 71
What are the key deliverables for User Acceptance Testing?
  • A. Project Plan
  • B. eCRF Completion Guidelines
  • C. Test Plan/Script/Results
  • D. Training
正解：C
解説：
The key deliverables for User Acceptance Testing (UAT) are the Test Plan, Test Scripts, and Test Results.
According to the GCDMP (Chapter: Database Design and Validation), UAT is the final validation step before a clinical database is released for production. It confirms that the system performs according to user requirements and protocol specifications.
The deliverables include:
UAT Test Plan: Defines testing objectives, scope, acceptance criteria, and responsibilities.
UAT Test Scripts: Provide step-by-step instructions for testing database functionality, edit checks, and workflows.
UAT Test Results: Document actual test outcomes versus expected outcomes, including any deviations and their resolutions.
These deliverables form part of the system validation documentation required under FDA 21 CFR Part 11 and ICH E6 (R2) to demonstrate that the database has been properly validated.
Project Plans (option A) and Training (option B) occur in earlier phases, while eCRF Completion Guidelines (option D) support site data entry, not system validation.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Validation, Section 5.3 - User Acceptance Testing Deliverables FDA 21 CFR Part 11 - Validation Documentation Requirements ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - System Validation Records

質問 # 72
What does RACI stand for?
  • A. Responsibility, Accountability, Consultation, Information
  • B. Recommend, Approve, Calibrate, Innovate
  • C. Responsible, Accountable, Consulted, Informed
  • D. Responsible, Accountable, Contribute, Input
正解：C
解説：
RACI is a project management and governance framework used to define roles and responsibilities within a project. Each letter represents a distinct role type:
Responsible (R): The person(s) who perform the work or execute the task.
Accountable (A): The individual ultimately answerable for the task's completion and success (only one per activity).
Consulted (C): Subject matter experts who provide input or guidance before decisions are made.
Informed (I): Individuals kept up to date on progress or outcomes but not directly involved in execution.
The RACI model ensures clarity in ownership and accountability, preventing duplication of effort or responsibility confusion. It is a key component of the GCDMP (Chapter: Project Management in Data Management) for ensuring clear delegation and communication within clinical data management teams.
Hence, option D is correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Project Management in Data Management, Section 5.1 - Roles, Responsibilities, and RACI Matrices Project Management Institute (PMI) Framework - Responsibility Assignment Matrices (RACI) ICH E6(R2) GCP, Section 5.1.1 - Defined Roles and Quality Oversight Responsibilities

質問 # 73
A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy and safety of a new blood thinner for prevention of secondary cardiac events. The stated endpoint is all-cause mortality at 1 year. Which data element would be required for the efficacy endpoint?
  • A. Date of death
  • B. Coagulation time
  • C. Drug level
  • D. Cause of death
正解：A
解説：
The efficacy endpoint of all-cause mortality at one year directly depends on the date of death for each subject, making Option D - Date of death the required data element.
According to the GCDMP (Chapter: Clinical Trial Protocols and Data Planning) and ICH E3/E9 Guidelines, the primary efficacy analysis must be based on time-to-event data, particularly when the endpoint involves mortality or survival. The date of death allows accurate calculation of time from randomization to event, essential for survival analysis (e.g., Kaplan-Meier curves).
While cause of death (C) may be collected for safety or secondary analyses, all-cause mortality specifically includes any death regardless of cause. Drug levels (A) and coagulation times (B) may serve as pharmacodynamic or exploratory endpoints but do not directly measure mortality.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Planning and Protocol Review, Section 5.4 - Defining Data Required for Endpoints ICH E9 - Statistical Principles for Clinical Trials, Section 2.3 - Time-to-Event Endpoints FDA Guidance for Industry: Clinical Trial Endpoints for Drug Development and Approval

質問 # 74
......
CCDM認定試験の準備をするために一生懸命勉強して疲れを感じるときには、他の人が何をしているかを知っていますか。あなたと同じIT認定試験を受験する周りの人を見てください。あなたが試験のために不安と感じているとき、どうして他の人が自信満々で、のんびり見ているのでしょうか。あなたの能力は彼らうより弱いですか。もちろんそんなことはないです。では、なぜ他の人が簡単にCCDM試験に合格することができるかを知りたいですか。それは彼らがTech4Exam のCCDM問題集を利用したからです。この問題集を勉強することだけで楽に試験に合格することができます。信じないのですか。不思議を思っていますか。では、急いで試してください。まず問題集のdemoを体験することができます。そうすれば、この問題集の品質を確認することができます。はやくTech4Examのサイトをクリックしてください。
CCDM認定試験トレーリング: https://www.tech4exam.com/CCDM-pass-shiken.html
2026年Tech4Examの最新CCDM PDFダンプおよびCCDM試験エンジンの無料共有：https://drive.google.com/open?id=1CgzL9kDDmP-weOOcbyljsZ52dJgzYLEu
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