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SCDM Certified Clinical Data Manager Sample Questions (Q139-Q144):

NEW QUESTION # 139
A Data Manager is designing a CRF for a study for which the efficacy data are not covered by the current SDTM domains. Which of the following should the Data Manager consult first?

A. A CDISC therapeutic-area implementation guide
B. Forms used by other sponsors in the same therapeutic area
C. Data elements used in clinical registries in the therapeutic area
D. SNOMED terms used in the therapeutic area

Answer: A

Explanation:
When efficacy data are not covered by existing CDISC SDTM domains, the first resource the Data Manager should consult is the CDISC Therapeutic Area Implementation Guide (TAIG) for that therapeutic field.
According to the GCDMP (Chapter: Standards and Data Mapping), CDISC's Therapeutic Area User Guides (TAUGs) and Implementation Guides provide standardized data structures, variable definitions, controlled terminology, and implementation examples for specific diseases or therapeutic areas. These guides ensure consistency across studies, promote interoperability, and align data collection with regulatory submission expectations.
Consulting other sponsors' forms or external registries (options A and C) can be informative but do not provide authoritative CDISC-compliant standards. SNOMED terms (option B) address medical terminology, not structural data domain definitions.
Therefore, Option D is correct-CDISC TA Implementation Guides are the recognized primary reference when extending or designing SDTM-compliant CRFs.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Standards and Data Mapping, Section 4.2 - Use of CDISC Standards CDISC Therapeutic Area User Guides (TAUGs) - Implementation Guidance for Domain Extension FDA Data Standards Catalog - CDISC Therapeutic Area Standards

NEW QUESTION # 140
Electronic submission standards require that an individual subject's complete CRF should be provided as what type of file:

A. Microsoft Word (.docx)
B. Rich Text Format (.rtf)
C. Portable Document Format (.pdf)
D. Statistical Analysis System (.sas)

Answer: C

Explanation:
Electronic submission standards, as established by FDA, CDISC, and ICH, require that an individual subject's complete Case Report Form (CRF) be submitted as a Portable Document Format (.pdf) file. The PDF format is universally recognized and accepted because it ensures that the structure, format, and visual fidelity of the CRF are preserved exactly as originally designed, regardless of software or hardware environment.
According to the FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format (2006) and CDISC SDTM standards, sponsors must include a subject-level CRF in PDF form for each participant in the submission dataset. This requirement ensures that reviewers can trace data points from analysis datasets back to their source entries in the CRF, fulfilling the principles of data traceability and transparency.
The Good Clinical Data Management Practices (GCDMP) also support this requirement, emphasizing that CRF archiving should maintain readability and regulatory accessibility. Formats like RTF, DOCX, or SAS datasets are not acceptable substitutes for regulatory CRF submission because they may alter formatting, structure, or introduce modifiable content, violating FDA data integrity principles.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Archiving and Submission FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format, April 2006 CDISC SDTM Implementation Guide, Section 5.3 - CRF Representation and Traceability

NEW QUESTION # 141
Which metric reveals the timeliness of the site-work dimension of site performance?

A. Median and range of time from query generation to resolution
B. Time from final protocol to first patient enrolled
C. Time from Last Patient Last Visit to database lock
D. Time from site contract execution to first patient enrolled

Answer: A

Explanation:
The site-work dimension of site performance evaluates how efficiently sites manage and resolve data-related tasks - particularly query resolution, data entry, and correction timelines. Among the given metrics, the median and range of time from query generation to resolution (D) directly measures the site's responsiveness and data management efficiency.
According to the GCDMP (Chapter on Metrics and Performance Measurement), this indicator helps identify sites that delay query resolution, which can impact overall study timelines and data quality. Tracking this metric allows the data management team to proactively provide additional training or communication to underperforming sites.
Other options measure different aspects of project progress:
A reflects overall database closure speed.
B and C relate to study startup and enrollment readiness, not ongoing data work.
Thus, option D accurately represents a site performance timeliness metric, aligning with CCDM principles for operational performance measurement.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Metrics and Performance Management, Section 5.4 - Site Query Resolution Metrics ICH E6(R2) Good Clinical Practice, Section 5.18 - Monitoring and Site Performance Oversight

NEW QUESTION # 142
Every database lock should follow documented approval of which stakeholders?

A. Clinical/Scientific Representative, Biostatistician
B. Clinical/Scientific Representative, Data Manager
C. Clinical/Scientific Representative, Data Manager, Biostatistician
D. Clinical/Scientific Representative, Biostatistician, Programmer

Answer: C

Explanation:
According to the Good Clinical Data Management Practices (GCDMP), the database lock (DBL) process signifies the formal closure of the clinical trial database, ensuring that no further changes can be made to the data before statistical analysis. This process must be documented, controlled, and approved by key study stakeholders to ensure data accuracy, completeness, and readiness for analysis.
The GCDMP specifies that database lock should occur only after all data cleaning, discrepancy resolution, and reconciliation activities are complete. The lock authorization typically requires the approval of the Clinical/Scientific Representative (to confirm clinical completeness), the Data Manager (to confirm data integrity and query closure), and the Biostatistician (to confirm readiness for statistical analysis).
This tri-party approval ensures that the database reflects final, verified data consistent with the clinical protocol, and that the statistical analysis dataset derived from the database is accurate and auditable. The approval process is documented via a Database Lock Authorization Form or Sign-off Log, which becomes part of the permanent trial master file (TMF).
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Lock and Archiving, Section 7.1 - Lock Procedures and Approvals ICH E6 (R2) GCP, Section 5.5.3 - Data Handling and Record Keeping FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations - Section on Database Closure

NEW QUESTION # 143
For a study, body mass index is calculated from weight and height. Which information is needed to document the transformation?

A. Algorithm and algorithm version associated with the calculated value
B. Algorithm associated with the calculated value
C. Algorithm documented in the Data Management Plan
D. User ID making the change and reason for change

Answer: A

Explanation:
When derived or calculated variables (like Body Mass Index) are created, it is essential to document the algorithm used and its version to ensure full data traceability and reproducibility.
According to GCDMP (Chapter: Database Design and Derived Data), every derived field must include metadata describing:
The derivation algorithm (e.g., BMI = weight [kg] / height² [m²])
The version of the algorithm (if updates or revisions occur)
Any associated data sources or transformation rules
This ensures consistent calculation across systems, prevents discrepancies during regulatory submissions, and aligns with FDA and CDISC documentation expectations.
Option B lacks version control, which is critical for traceability. Option C describes audit trail data (not derivation metadata), and option D refers to broader documentation, not specific algorithm traceability.
Hence, option A (Algorithm and algorithm version associated with the calculated value) is the correct and compliant answer.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Derived Data and Algorithms, Section 5.3 - Documentation and Metadata Requirements ICH E6(R2) GCP, Section 5.5.3 - Derived Data and Validation Traceability FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Data Definitions (Define.xml)

NEW QUESTION # 144
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