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SCDM Certified Clinical Data Manager Sample Questions (Q88-Q93):

NEW QUESTION # 88
For clinical investigational sites on an EDC trial, which of the following archival options allows traceability of changes made to data?

A. ASCII files of the site's data and related audit trails
B. Paper copies of the source documents
C. PDF images of the final eCRF screens for each patient
D. Storing the computer used at the clinical investigational site

Answer: A

Explanation:
Regulatory agencies such as the FDA and ICH require that electronic data be retained in a format that preserves audit trails and traceability.
While PDF images (option C) provide a static representation of data, they do not preserve the underlying audit trail (i.e., who changed what, when, and why). The ASCII data files with corresponding audit trails (option D) provide complete transparency and comply with 21 CFR Part 11 and GCDMP archival standards.
Option A (storing computers) is unnecessary and impractical, and Option B (paper source documents) are site records, not system archives.
Hence, option D is correct - ASCII data files with audit trails meet traceability and compliance standards.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Database Lock and Archiving, Section 5.4 - Archival Formats and Audit Trail Retention ICH E6(R2) GCP, Section 5.5.3 - Data Integrity, Audit Trails, and Record Retention FDA 21 CFR Part 11 - Electronic Records; Audit Trail and Retention Requirements

NEW QUESTION # 89
ePRO data are collected for a study using study devices given to subjects. Which is the most appropriate quality control method for the data?

A. Programmed edit checks to detect out of range values upon data entry
B. Manual review of data by the site study coordinator at the next visit
C. Data visualizations to look for site-to-site variation
D. Programmed edit checks to detect out of range values after submission to the database

Answer: A

Explanation:
When electronic patient-reported outcomes (ePRO) devices are used, data are captured directly by subjects through validated devices and transmitted electronically to the study database. To ensure real-time data quality control, programmed edit checks should be implemented at the point of data entry - that is, as subjects input data into the device.
According to Good Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning), front-end programmed edit checks are the optimal method to prevent entry of invalid or out-of-range values in ePRO systems. This helps maintain data accuracy at the source, minimizing downstream queries and data cleaning workload.
Options A and B involve post-submission or manual review, which is less efficient and not compliant with the principle of first-pass data validation. Option C (visualization) is a valuable secondary QC method for trends, but not for immediate data validation.
Therefore, option D is correct - programmed edit checks upon data entry ensure immediate validation and higher data integrity.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 5.3 - Automated Edit Checks and Front-End Validation ICH E6(R2) GCP, Section 5.5.3 - Computerized System Controls and Validation FDA Guidance for Industry: Electronic Source Data in Clinical Investigations (2013), Section 6 - Real-Time Data Quality Control

NEW QUESTION # 90
In the EDC database, which factors are considered when defining user roles?

A. Protocol Review and Data Entry
B. Data Review and Analysis Programming
C. Data Entry and Data Review
D. Patient Recruitment and Protocol Review

Answer: C

Explanation:
In Electronic Data Capture (EDC) systems, user roles are defined based on the functions and permissions required for specific study tasks. The most fundamental and universally applicable roles are Data Entry (performed by site staff) and Data Review (performed by monitors or data managers).
According to the GCDMP (Chapter: Technology and Electronic Data Capture Systems), defining user roles involves:
Assigning functional access levels (e.g., entry, review, query resolution).
Ensuring role-based security to protect data integrity.
Complying with 21 CFR Part 11 and ICH E6(R2) access control standards.
Options B, C, and D include functions (protocol review, analysis programming) not directly controlled within an EDC system.
Thus, option A (Data Entry and Data Review) correctly represents the two core factors considered when defining user roles.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Technology and Electronic Data Capture Systems, Section 4.3 - User Access, Roles, and Permissions ICH E6(R2) GCP, Section 5.5.3 - System Access and Security Controls FDA 21 CFR Part 11 - Access Control and Audit Trail Requirements

NEW QUESTION # 91
Which action has the most impact on the performance of a relational database system?

A. Loading a large lab data file into the database
B. Entering data into the database from CRFs
C. Making updates to data previously entered into the database
D. Executing a properly designed database query

Answer: A

Explanation:
In a relational database system used in clinical data management, performance refers to how efficiently the system processes transactions, retrieves data, and handles large volumes of information without delay or data integrity issues. Among the listed options, loading a large lab data file into the database (Option B) has the most significant impact on database performance.
According to the Good Clinical Data Management Practices (GCDMP, Chapter on Database Design and Build), the bulk data load process - such as importing large external datasets (e.g., central lab data, ECG results, or imaging metadata) - can be computationally intensive. This process engages the database's input/output (I/O) subsystem, indexing mechanisms, and transaction logs simultaneously, often locking tables temporarily and consuming significant memory and processing resources.
Unlike standard CRF data entry (Option A) or record updates (Option D), which are incremental and typically processed in smaller transactional batches, bulk loading operations handle thousands or millions of rows at once. If not optimized (e.g., via staging tables, indexing strategies, or commit frequency control), such operations can degrade system performance, slow down concurrent user access, and increase the risk of transaction failure.
Executing a properly designed query (Option C) can also be resource-intensive depending on data volume and join complexity, but when queries are properly optimized (using indexed keys, efficient SQL joins, and selective retrieval), their impact is generally controlled and transient compared to large data imports.
Therefore, as outlined in the GCDMP Database Design and Build and FDA Computerized Systems Guidance, the most performance-impacting activity in a relational database is bulk loading large external datasets, making Option B the correct answer.
Reference (CCDM-Verified Sources):
Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Build, Section 6.7 - Database Performance and Optimization FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6 - System Performance and Data Handling Efficiency ICH E6 (R2) Good Clinical Practice, Section 5.5 - Data Handling and Record Integrity CDISC Operational Data Model (ODM) Implementation Guide - Bulk Data Transfer and Validation Considerations

NEW QUESTION # 92
Which information is most useful in working with sites to catch up a backlog of unresolved queries at sites?

A. Graph of expected versus actual enrollment
B. Table of outstanding queries counts by site
C. List of late queries by site and summary table
D. Graph and summary table of clean cases by site

Answer: C

Explanation:
The most effective information for addressing a backlog of unresolved queries at investigative sites is a list of late queries by site combined with a summary table.
According to the GCDMP (Chapter: Communication and Issue Escalation), timely and structured feedback to sites is critical for efficient query resolution. A detailed list of late or overdue queries, accompanied by summary statistics (e.g., counts, durations, status), enables data managers and monitors to prioritize follow-up actions, target problem areas, and provide focused support or retraining to underperforming sites.
While query count summaries (option B) are helpful for overview metrics, they lack the specific information (query ID, date, field, status) required for targeted follow-up. Graphs of enrollment or clean cases (options A and C) are unrelated to discrepancy resolution performance.
Thus, the combination of detailed lists and summarized performance metrics offers both granularity and a high-level overview - the optimal tool for query management communication.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Communication and Issue Escalation, Section 5.1 - Site Query Management Reports ICH E6 (R2) GCP, Section 5.18.4 - Communication Between Monitors and Sites FDA Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Monitoring, Section on Query Metrics and Site Performance Review

NEW QUESTION # 93
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