Data Collection Methods Flashcards
7 cards from real CCDM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Data Collection Methods flashcards as text
Which principle of Good Clinical Data Management Practice (GCDMP) requires that all collected data be traceable to the original source?
Answer: Source data verification (SDV)
SDV ensures that data recorded in the CRF or EDC can be verified against the original source documents at the investigative site.
In a multicenter trial, what is the MAIN challenge of using multiple paper CRF versions across sites?
Answer: Inconsistent data collection leading to comparability issues
Different CRF versions across sites can produce inconsistent data fields, making cross-site data comparisons unreliable.
What does 'targeted SDV' mean in the context of risk-based monitoring?
Answer: Focusing verification on critical data fields and high-risk sites
Targeted SDV concentrates verification resources on the most critical data points and sites identified as higher risk.
Which method is used to collect pharmacokinetic (PK) data in clinical trials?
Answer: Blood and urine sample collection with laboratory analysis
PK data is derived from biological samples such as blood or urine that are analyzed to measure drug concentrations over time.
A sponsor decides to implement central monitoring in addition to on-site monitoring. What type of data collection insight does central monitoring primarily provide?
Answer: Statistical signals and outliers identified from aggregated site data
Central monitoring analyzes aggregated data across sites to detect statistical anomalies, trends, and potential data integrity issues.
Which term describes the process of capturing data from external sources such as laboratories and transferring it into the clinical database?
Answer: External data transfer or data import
External data transfers involve importing structured data files from vendors like central labs into the trial's clinical database.
In an eClinical environment, which standard is most commonly used to define the structure of data transferred between a laboratory and the EDC system?
Answer: HL7 or CDISC LAB XML format
HL7 and CDISC LAB XML formats are widely used standards for electronic exchange of laboratory data between external vendors and clinical systems.