SCDM CCDM 試験概要:
| 認定ベンダー: | Society for Clinical Data Management (SCDM) |
| 試験名: | Certified Clinical Data Manager |
| 試験番号: | CCDM |
| 試験形式: | 選択式, 遠隔監督付き |
| 合格点: | SCDMにより決定される換算スコア |
| 出題数: | 150 |
| 関連資格: | CCDS CCDA |
| 認定の有効期間: | 3年 |
| 対応言語: | 英語 |
| 受験料: | USD $250-$325 |
| 試験時間: | 210 分 |
| サンプル問題: | SCDM CCDM サンプル問題 |
| 受験方法: | オンラインの遠隔監督付き試験 |
| 前提条件: | 学士号と2年以上のCDM実務経験、または準学士号と3年以上の経験、あるいは4年以上のCDM実務経験。 |
| 公式シラバスのURL: | https://scdm.org/ccdm-certification/ |
SCDM CCDM 認定試験の出題範囲:
| トピック | 出題範囲 |
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| トピック 1 | - Design Tasks: This section of the CCDM exam measures skills of Data Managers and covers how to design and document data collection instruments, develop workflows and data flows, specify data elements, CRF forms, edit checks, reports, database structure, and define standards and procedures for traceability and auditability.
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| トピック 2 | - Review Tasks: This section measures the skills of Data Managers and involves reviewing protocols, CRFs, data tables, listings, figures, and clinical study reports (CSRs) for consistency, accuracy, and alignment with data handling definitions and regulatory requirements.
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| トピック 3 | - Testing Tasks: This section measures the skills of Data Managers and involves creating test plans, generating test data, executing validation and user acceptance testing, and documenting results to ensure systems and processes perform reliably and according to specifications.
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| トピック 4 | - Data Processing Tasks: This section measures skills of Clinical Systems Analysts and focuses on handling, transforming, integrating, reconciling, coding, querying, updating, and archiving study data while maintaining quality, consistency, and proper privileges over the data lifecycle.
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| トピック 5 | - Coordination and Project Management Tasks: This domain evaluates the skills of a Clinical Systems Analyst in coordinating data management workload, vendor selection, scheduling, cross-team communication, project timeline management, risk handling, metric tracking, and preparing for audits.
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参照:https://scdm.org/ccdm-certification/