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CCDM Exam Preview | Exam CCDM Outline

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SCDM CCDM Exam Syllabus Topics:

Topic
Details

Topic 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.

Topic 2

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.

Topic 3

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.

Topic 4

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.

Topic 5

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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Exam CCDM Outline - CCDM Accurate Answers

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SCDM Certified Clinical Data Manager Sample Questions (Q100-Q105):

NEW QUESTION # 100
Which competency is necessary for EDC system use in a study using the medical record as the source?

A. Screening study subjects
B. Training on how to log into Medical Records system
C. Using ePRO devices
D. Resolving discrepant data

Answer: B

Explanation:
In studies where the medical record serves as the source document, the Electronic Data Capture (EDC) system users (typically study coordinators or site personnel) must have appropriate training on how to access and log into the medical record system. This competency ensures that data abstracted from the electronic medical record (EMR) are complete, accurate, and verifiable in compliance with Good Clinical Practice (GCP) and Good Clinical Data Management Practices (GCDMP).
According to the GCDMP (Chapter: EDC Systems and Data Capture) and ICH E6(R2), all personnel involved in data entry and verification must be trained in both the EDC and the primary source systems (e.g., EMR). This ensures that the integrity of data flow-from source to EDC-is maintained, and that personnel understand system access controls, audit trails, and proper documentation of source verification.
While resolving discrepant data (C) and screening subjects (A) are part of study operations, the competency directly related to EDC system use in EMR-based studies is the ability to properly log into and navigate the medical records system to extract source data.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Electronic Data Capture (EDC), Section 5.1 - Source Data and System Access Requirements ICH E6(R2) Good Clinical Practice, Section 4.9 - Source Documents and Data Handling FDA Guidance: Use of Electronic Health Record Data in Clinical Investigations, Section 3 - Investigator Responsibilities

NEW QUESTION # 101
A Data Manager is designing a report to facilitate discussions with sites regarding late dat a. Which is the most important information to display on the report to encourage sites to provide data?

A. Total number of forms entered to date
B. Expected versus actual forms entered
C. List of outstanding forms
D. Number of forms entered in the last week

Answer: C

Explanation:
In managing site data timeliness, the most actionable and effective tool is a report listing all outstanding (missing or incomplete) CRFs.
According to GCDMP (Chapter: Communication and Study Reporting), Data Managers must provide site-level performance reports highlighting:
Outstanding CRFs not yet entered,
Unresolved queries, and
Pending data corrections.
Such reports help sites prioritize and address data gaps efficiently.
Option A and D are historical metrics without actionable context.
Option B gives a general overview but lacks specific site-level actionability.
Hence, option C (List of outstanding forms) provides the clearest and most motivating feedback to sites for timely data entry and query resolution.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Communication and Study Reporting, Section 5.3 - Data Timeliness and Reporting Metrics ICH E6(R2) GCP, Section 5.1.1 - Sponsor Oversight and Data Communication Requirements FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.5 - Site-Level Data Timeliness Reporting

NEW QUESTION # 102
Which of the following roles commonly requires data entry and update privileges in an EDC application used in a clinical study?

A. Clinical Study Monitor
B. EDC System Administrator
C. Study Statistician
D. Site Study Coordinator

Answer: D

Explanation:
In an EDC system, Site Study Coordinators are typically responsible for data entry and updates, as they are the site-level personnel who record subject data from source documents into the electronic CRFs (eCRFs).
The Good Clinical Data Management Practices (GCDMP, Chapter: EDC Systems) outlines that data entry and modification privileges should only be granted to qualified site personnel who have completed EDC system training and are listed on the study delegation log. These users directly handle patient-level data entry and correction.
In contrast:
Clinical Study Monitors (B) review and verify data but do not enter or modify it.
EDC System Administrators (C) manage user access and configuration settings, not study data.
Study Statisticians (D) work with extracted, cleaned datasets but never have data modification privileges.
Thus, option A (Site Study Coordinator) correctly identifies the role with authorized data entry and update privileges.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.2 - User Roles and Access Permissions ICH E6(R2) GCP, Section 4.1 - Investigator Responsibilities for Data Accuracy FDA 21 CFR Part 11 - User Access and Accountability in Electronic Systems

NEW QUESTION # 103
The Medical Dictionary for Regulatory Activities (MedDRA) structure is in which of the following hierarchical orders, from most specific to least specific?

A. LLT, PT, HLGT, HLT, SOC
B. LLT, PT, HLT, HLGT, SOC
C. LLT, HLGT, HLT, PT, SOC
D. LLT, HLGT, PT, HLT, SOC

Answer: B

Explanation:
The MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology used for coding and analyzing adverse event (AE) and medical history data in clinical trials. Its hierarchical structure supports aggregation, analysis, and reporting across varying levels of medical specificity.
From most specific to least specific, the hierarchy is as follows:
Lowest Level Term (LLT): The most granular term, often reflecting the verbatim text reported by the investigator.
Preferred Term (PT): The standardized medical concept representing one or more LLTs describing the same condition.
High Level Term (HLT): A grouping of related PTs describing similar medical conditions.
High Level Group Term (HLGT): A broader grouping of related HLTs.
System Organ Class (SOC): The highest level of classification, grouping HLGTs by body system or etiology (e.g., cardiac disorders, infections).
Thus, the correct order - from most specific to least specific - is:
LLT → PT → HLT → HLGT → SOC, which corresponds to option D.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Medical Coding and Dictionaries, Section 5.2 - MedDRA Hierarchical Structure ICH M1 MedDRA Terminology Guide, Version 26.0 - Hierarchy Overview ICH E2B(R3) Guidelines - Clinical Safety Data Management

NEW QUESTION # 104
What additional task does the site study coordinator role perform when utilizing an EDC application compared to paper CRF?

A. Medical record abstraction
B. Data entry
C. Data curation
D. Resolving queries

Answer: B

Explanation:
In paper-based trials, site staff (e.g., study coordinators) record data manually on paper Case Report Forms (CRFs), which are later transcribed by data entry personnel into an electronic database.
However, in EDC-based studies, the site coordinator is directly responsible for entering data into the EDC system. This eliminates the need for centralized double data entry and shortens data cleaning timelines.
The GCDMP (Chapter: Electronic Data Capture Systems) states that EDC systems shift certain tasks, including data entry, initial query response, and source verification preparation, to the site level. Yet, data entry remains the most significant additional responsibility compared to paper-based studies.
Option A (Query resolution) is performed in both EDC and paper-based systems.
Option C (Data curation) is typically a Data Management function.
Option D (Medical record abstraction) is part of source documentation, not specific to EDC.
Thus, option B (Data entry) is correct - it is the additional site coordinator duty unique to EDC environments.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.3 - Site Responsibilities and Workflow Changes ICH E6(R2) GCP, Section 5.5.3 - Data Entry and Role Delegation in Computerized Systems FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.2 - Site-Level Data Entry Controls

NEW QUESTION # 105
......

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