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[General] Reliable CCDM Test Notes - CCDM Verified Answers

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【General】 Reliable CCDM Test Notes - CCDM Verified Answers

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SCDM CCDM Exam Syllabus Topics:
TopicDetails
Topic 1
  • 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 2
  • 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 3
  • 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 4
  • 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.
Topic 5
  • 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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SCDM Certified Clinical Data Manager Sample Questions (Q14-Q19):NEW QUESTION # 14
Which of the following is a best practice for creating eCRFs for a study?
  • A. Develop eCRFs with cross-functional team members
  • B. Set up features that automatically enter data into fields when bypassed
  • C. Develop eCRFs that closely follow paper CRF standards
  • D. Set up coded terms so they are available to the site user
Answer: A
Explanation:
The best practice for developing electronic Case Report Forms (eCRFs) is to involve cross-functional team members throughout the design process.
According to the GCDMP (Chapter: CRF Design and Data Collection), eCRFs should be collaboratively developed by data management, clinical operations, biostatistics, medical, and regulatory teams. Each function provides a unique perspective - data managers focus on data capture and validation; statisticians ensure alignment with analysis requirements; clinicians ensure medical relevance and protocol compliance.
Collaborative development ensures that the eCRFs are fit-for-purpose, capturing all required data accurately, minimizing redundancy, and supporting downstream data analysis.
Options A and B violate good data management practice because sites should not directly access coded terms (to prevent bias), and fields should never auto-populate without explicit source verification. Option D is outdated; while paper CRFs may inform structure, EDC-optimized eCRFs should leverage system functionality rather than mimic paper.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.2 - Collaborative CRF Development ICH E6 (R2) GCP, Section 5.5.3 - Data Collection and System Validation FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 3.4 - CRF Design Considerations

NEW QUESTION # 15
In a cross-functional team meeting, a monitor mentions performing source data verification (SDV) on daily diary data entered by patients on mobile devices. Which of the following is the best response?
  • A. All diary data should be source data verified
  • B. Diary data to be source data verified should be randomly selected
  • C. Diary data to be source data verified should be selected using a risk-based approach
  • D. The diary data should not be source data verified
Answer: C
Explanation:
The best response is that diary data to be source data verified should be selected using a risk-based approach.
According to the GCDMP (Chapter: Data Quality Assurance and Control) and FDA Guidance on Risk-Based Monitoring (RBM), not all data require full SDV. Electronic patient-reported outcome (ePRO) or mobile diary data are typically direct electronic source data (eSource) captured at the time of entry, which already ensures authenticity and traceability.
A risk-based SDV approach focuses verification efforts on data critical to subject safety and primary efficacy endpoints, as defined in the study's Risk Assessment Plan or Monitoring Plan. Random or full verification of low-risk data (like diary compliance metrics) adds unnecessary effort and cost.
Thus, Option C aligns with current regulatory expectations and data management best practices.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 7.3 - Risk-Based Monitoring and SDV ICH E6 (R2) Good Clinical Practice, Section 5.18 - Risk-Based Quality Management FDA Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring (2013)

NEW QUESTION # 16
Which document describes what study subjects expect with respect to data disclosure during and after a study?
  • A. Informed consent form
  • B. ICH essential documents
  • C. Study protocol
  • D. Study data sharing plan
Answer: A
Explanation:
The Informed Consent Form (ICF) is the document that explicitly describes what study subjects can expect regarding data disclosure, privacy, and confidentiality during and after participation in a clinical trial. According to ICH E6 (R2) Good Clinical Practice and FDA Human Subject Protection Regulations (21 CFR Parts 50 and 56), participants must be fully informed about how their personal and clinical data will be collected, used, stored, and shared - both during the study and in any subsequent data-sharing or publication activities.
The GCDMP reiterates that clinical data managers must ensure that all data handling practices align with the privacy commitments made in the ICF. This includes compliance with data protection regulations such as HIPAA (in the U.S.) and GDPR (in the EU). The ICF defines the permissible scope of data use, ensuring ethical management and subject protection.
Documents like the protocol or data sharing plan may outline procedures and responsibilities but do not directly inform participants of their rights and data use expectations. Only the ICF is designed for that ethical communication purpose.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Ethics, Privacy, and Data Security ICH E6 (R2) Good Clinical Practice, Sections 4.8.10 & 4.8.12 FDA 21 CFR Part 50 - Protection of Human Subjects, Informed Consent Requirements

NEW QUESTION # 17
The result set from the query below would be which of the following?
SELECT Pt_ID, MRN, SSN FROM patient
  • A. Wider than the patient table
  • B. Shorter than the patient table
  • C. Narrower than the patient table
  • D. Longer than the patient table
Answer: C
Explanation:
In a SQL (Structured Query Language) database, the SELECT statement specifies which columns to display from a table. In this query, only three columns - Pt_ID, MRN, and SSN - are being selected from the patient table.
This means the resulting dataset will contain:
The same number of rows (records) as the original table (assuming no WHERE filter), and Fewer columns than the full table.
In database terminology:
"Wider" refers to more columns (fields).
"Narrower" refers to fewer columns (fields).
Since this query retrieves only 3 columns (out of potentially many in the original table), the result set is narrower than the patient table, making option D correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Database Design and Build, Section 5.1 - Relational Databases and Query Logic ICH E6(R2) GCP, Section 5.5.3 - Data Retrieval and Integrity Principles FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 - Database Query Controls

NEW QUESTION # 18
A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy of an antiviral to counteract a new epidemic. The stated primary efficacy endpoint is 3-month survival. Which data element is needed for the primary efficacy endpoint?
  • A. Death date
  • B. Cause of death
  • C. Date of autopsy
  • D. Birth date
Answer: A
Explanation:
When the primary efficacy endpoint in a clinical trial is 3-month survival, the key data element required is the death date. This is because the survival endpoint is determined by calculating whether the subject lived or died within a defined time frame from study enrollment or randomization.
According to the GCDMP (Chapter: Data Management Planning and Study Start-up), the Clinical Data Manager (CDM) must identify and ensure the capture of all critical data elements necessary to evaluate the study endpoints. For time-to-event analyses (e.g., survival studies), accurate event dates (death date) are essential for endpoint derivation and statistical analysis.
Other data elements such as cause of death or date of autopsy (options B and C) may support secondary analyses or safety reviews but are not necessary to determine the survival endpoint itself. Similarly, birth date (option D) contributes to demographic data but is unrelated to the primary efficacy outcome.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Planning and Study Start-up, Section 4.4 - Critical Data Identification for Endpoints ICH E9 - Statistical Principles for Clinical Trials, Section 2.2.3 - Time-to-Event Data Considerations FDA Guidance for Industry: Clinical Trial Endpoints for Drug Development

NEW QUESTION # 19
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