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A data manager takes the INTERSECTION data in two tables wanting only the 50 records common to both tables. What operation did the data manager perform?
A. Right outer join
B. Full outer join
C. Inner join
D. Left outer join
Answer: C
Explanation:
The inner join operation retrieves only the records that exist in both tables, which is the intersection of two datasets.
In clinical data management, relational databases often store related data in multiple tables-for example, demographic data in one table and lab results in another. When a Data Manager needs to extract records that exist in both (e.g., subjects appearing in both demographics and labs), an inner join is used.
According to the GCDMP (Chapter: Database Design and Build), joins are fundamental relational operations ensuring data consistency and integrity across multiple data domains.
Inner join: Returns matching records from both tables (intersection).
Left/right outer joins: Return all records from one table and matching records from the other (preserving nonmatches).
Full outer join: Returns all records from both tables, whether matched or not.
Therefore, to select only the 50 records common to both tables, the correct operation is an inner join.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Build, Section 4.3 - Relational Database Concepts and Joins ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Data Processing and Validation
NEW QUESTION # 41
Which is the best way to identify sites with high subject attrition?
A. Number of late visits per site
B. Proportion of patients for which two visit periods have passed without data by site
C. Number of patients for which two visit periods have passed without data
D. Proportion of late visits by site
Answer: B
Explanation:
The best method to identify sites with high subject attrition is to calculate the proportion of patients for which two visit periods have passed without data, by site.
According to the GCDMP (Chapter: Data Quality Assurance and Control), subject attrition is an important performance indicator for data completeness and site compliance. Evaluating missing or delayed data across multiple consecutive visit periods allows for early detection of potential dropouts or site-level operational issues.
By assessing this proportion at the site level, the Data Manager can distinguish between random missing data and systematic site underperformance. Counting or proportioning late visits (options B and C) identifies scheduling delays, not attrition. Looking at missing data without site context (option D) fails to identify site-specific patterns, limiting corrective action.
This metric aligns with risk-based monitoring (RBM) practices recommended by ICH E6 (R2) and FDA RBM Guidance, which promote proactive identification of sites at risk of data loss.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 5.4 - Site Performance Metrics ICH E6 (R2) Good Clinical Practice, Section 5.18 - Monitoring and Site Performance Evaluation FDA Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Monitoring, Section 6 - Site Performance Metrics
NEW QUESTION # 42
The Scope of Work would answer which of the following information needs?
A. To determine the number of data transfers budgeted for a project
B. To find the name and contact information of a specific clinical data associate
C. To look up which visit PK samples are taken
D. To look up the date of the next clinical monitoring visit for a specific site
Answer: A
Explanation:
The Scope of Work (SOW) is a project management document that defines what services are included in the work agreement between the sponsor and the CRO or vendor. It outlines deliverables, responsibilities, timelines, and budget allocations.
According to the GCDMP (Chapter: Project Management in Data Management), the SOW includes specifications such as:
The number and frequency of data transfers,
Database build and lock milestones,
Quality control deliverables, and
Resource allocation for data management tasks.
The SOW does not cover operational site-level details such as monitoring schedules (B), protocol sampling details (C), or personnel contact lists (D).
Therefore, option A (number of data transfers budgeted for a project) correctly identifies a use case directly addressed in the SOW.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Project Management, Section 4.1 - Scope of Work and Resource Planning ICH E6(R2) GCP, Section 5.5 - Sponsor Oversight and Data Management Responsibilities PMI Project Management Framework - Scope Definition and Deliverable Specifications
NEW QUESTION # 43
An organization conducts over fifty studies per year. Currently each study is specified and set-up from scratch. Which of the following organizational infrastructure options would streamline database set-up and study-to-study consistency?
A. Improving the form or screen design process
B. Implementing controlled terminology for adverse events
C. Maintaining a library of form or screen modules
D. Adopting an ODM compliant database system
Answer: C
Explanation:
To improve efficiency and ensure consistency across multiple studies, the most effective infrastructure solution is to maintain a centralized library of standardized forms or screen modules (e.g., CRF/eCRF templates).
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Database Design and Build), using a form library allows reuse of validated data collection modules for commonly collected domains such as demographics, adverse events, and vital signs. This reduces database setup time, enhances uniformity in data definitions, and ensures alignment with standards such as CDISC CDASH and SDTM.
While adopting ODM (A) provides standardized data exchange and interoperability, it does not inherently reduce setup workload. Improving design processes (C) enhances efficiency but doesn't guarantee consistency, and implementing controlled terminology (D) helps with coding standardization, not database structure.
Therefore, option B - maintaining a library of form or screen modules - provides the most direct and sustainable improvement for scalability and quality.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Database Design and Build, Section 5.3 - Use of Standard Libraries and Templates CDISC CDASH Implementation Guide, Section 3.2 - Reusable CRF Modules and Standardization ICH E6(R2) GCP, Section 5.5.3 - Standardization and Reuse in Data Collection Systems
NEW QUESTION # 44
An asthma study is taking into account local air quality and receives that data from the national weather bureau. Which information is needed to link research subject data to the air-quality readings?
A. Location and time identifiers
B. Location identifier
C. Location, time and subject identifiers
D. Location, time, subject and site identifiers
Answer: A
Explanation:
When integrating external environmental data such as air quality readings with clinical study data, it is essential to use location and time identifiers to properly align the environmental data with subject-level data.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Data Management Planning and Study Start-up), external data sources (like national weather or pollution databases) must be merged using common linkage variables that allow synchronization without breaching subject confidentiality. In this case:
Location identifiers (e.g., city, postal code, or region) align the subject's study site or residential area with the environmental dataset.
Time identifiers (e.g., date and time of data collection) ensure that the environmental readings correspond to the same period as the subject's clinical observations.
Including subject identifiers (option C or D) is unnecessary and would pose privacy and data protection risks. Instead, linkage is typically done at the aggregate (site or regional) level, maintaining compliance with HIPAA and GDPR.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Integration and External Data Handling, Section 4.3 - Linking External Data Sources ICH E6 (R2) GCP, Section 5.5.3 - Data Traceability and External Data Management FDA Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations, Section 5.2 - Linking and Integration Principles
NEW QUESTION # 45
......
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