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[General] CCDM Frequent Updates & Test CCDM Tutorials

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【General】 CCDM Frequent Updates & Test CCDM Tutorials

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SCDM CCDM Exam Syllabus Topics:
TopicDetails
Topic 1
  • 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 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
  • 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 4
  • 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 5
  • 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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SCDM Certified Clinical Data Manager Sample Questions (Q14-Q19):NEW QUESTION # 14
Which of the following SOPs are required for management of an EDC system?
  • A. Measurement of data quality
  • B. Maintenance of coding dictionaries
  • C. Change control
  • D. Management of vendors
Answer: C
Explanation:
The most essential Standard Operating Procedure (SOP) for management of an Electronic Data Capture (EDC) system is Change Control.
Per GCDMP (Chapter: Computerized Systems and Compliance) and FDA 21 CFR Part 11, any changes made to an EDC system-whether to software configuration, study database design, or system functionality-must follow a documented, validated, and auditable change control process. This ensures that:
Modifications are properly authorized, tested, and approved before implementation.
System validation remains intact.
Data integrity, traceability, and regulatory compliance are maintained.
While vendor management (A) and coding maintenance (C) have supporting SOPs, change control (D) is mandatory for any system handling regulated clinical data. Measurement of data quality (B) is important but not specifically tied to system management procedures.
Thus, option D (Change control) is the correct answer.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Computerized Systems and Compliance, Section 5.3 - Change Control and System Maintenance FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures, Section 11.10(a-k) ICH E6(R2) GCP, Section 5.5.3 - Computerized Systems Validation and Change Documentation

NEW QUESTION # 15
The best example of a protocol compliance edit check is:
  • A. An edit check that fires when an invalid date is entered
  • B. An edit check that fires when a visit date is outside the specified window
  • C. An edit check that fires when a field is left blank
  • D. An edit check that fires when a value is outside of the normal range for vital signs
Answer: B
Explanation:
A protocol compliance edit check is designed to ensure that the data collected adheres to the specific requirements defined in the study protocol, such as visit timing, procedure windows, and eligibility criteria.
The example in option A - an edit check that triggers when a visit date falls outside the protocol-specified window - directly verifies compliance with the study design. This type of check supports real-time monitoring of protocol adherence, a critical quality and regulatory requirement under GCDMP and ICH E6(R2).
Other options are examples of general data validation checks, not protocol compliance:
B: Ensures clinical plausibility (data range check).
C: Ensures completeness (missing data check).
D: Ensures format correctness (system validation check).
Thus, option A best represents a protocol compliance edit check, confirming that collected data conform to the visit schedule defined in the protocol.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 5.4 - Protocol Compliance Edit Checks ICH E6(R2) GCP, Section 5.1.1 - Quality Management and Compliance Controls FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.3 - Edit Check Design and Validation

NEW QUESTION # 16
What is the main reason 21 CFR Part 11 requires that EDC systems maintain an audit trail?
  • A. To preserve the ability for modifications
  • B. To preserve data availability
  • C. To preserve source document verifications
  • D. To preserve data integrity
Answer: D
Explanation:
The primary purpose of maintaining an audit trail as required under 21 CFR Part 11 is to preserve data integrity. According to the U.S. FDA's regulation on electronic records and signatures, every change to electronic data must be traceable, including information about who made the change, when it was made, and what the change entailed.
The Good Clinical Data Management Practices (GCDMP) outlines that an audit trail provides a permanent, chronological record of all modifications to clinical data. This ensures transparency and allows the reconstruction of the course of data entry and modification. The regulation aims to prevent unauthorized or undocumented data manipulation, thereby maintaining the accuracy, reliability, and validity of electronic records.
The FDA 21 CFR Part 11, Section 11.10(e) explicitly mandates that systems must use secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. This ensures the data remains trustworthy and defensible in regulatory reviews or inspections.
Therefore, the main reason for requiring an audit trail is to preserve data integrity - ensuring that all data captured, modified, or transmitted is authentic, accurate, and complete throughout the study lifecycle.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Compliance and Data Integrity FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures, Section 11.10(e) ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Data Integrity and System Validation

NEW QUESTION # 17
Which document describes what study subjects expect with respect to data disclosure during and after a study?
  • A. Informed consent form
  • B. Study protocol
  • C. Study data sharing plan
  • D. ICH essential documents
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 # 18
A study numbers subjects sequentially within each site and does not reuse site numbers. Which information is required when joining data across tables?
  • A. Study number and subject number
  • B. Subject number
  • C. Subject number and site number
  • D. Site number
Answer: C
Explanation:
When subjects are numbered sequentially within each site, it means that the subject identification numbers (Subject IDs) restart from 001 at each site. For example, Site 101 may have Subject 001, and Site 102 may also have a Subject 001. In such cases, the subject number alone is not globally unique across the entire study. Therefore, when integrating or joining data across multiple database tables (for example, linking demographic, adverse event, and laboratory data), both the site number and the subject number are required to create a unique key that accurately identifies each record.
According to the Good Clinical Data Management Practices (GCDMP, Chapter on CRF Design and Data Collection), every data record in a clinical trial database must be uniquely and unambiguously identified. This is typically achieved through a composite key, combining identifiers such as site number, subject number, and sometimes study number. The GCDMP specifies that a robust data structure must prevent duplication or mislinking of records across domains or tables.
Furthermore, FDA and CDISC standards (SDTM model) also emphasize the importance of unique subject identifiers (USUBJID), which are derived from concatenating the study ID, site ID, and subject ID. This ensures traceability, integrity, and accuracy of subject-level data during database joins, data exports, and regulatory submissions.
Thus, in the described scenario, since subject numbering restarts at each site, both the site number and subject number are required to uniquely identify and correctly join subject data across different datasets or tables.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.1 - Unique Subject Identification CDISC SDTM Implementation Guide, Section 5.2 - Subject and Site Identification (Variable: USUBJID) FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6 - Data Integrity and Record Identification

NEW QUESTION # 19
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