Electronic Data Capture 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 Electronic Data Capture flashcards as text
In risk-based monitoring (RBM), EDC data is used to identify 'Key Risk Indicators (KRIs).' What do KRIs primarily help sponsors do?
Answer: Prioritize monitoring resources toward sites with higher data quality risks
KRIs derived from EDC data help sponsors identify sites or data patterns that pose elevated risk, allowing targeted allocation of monitoring resources.
A clinical data manager discovers that a site has been entering data weeks after events occurred. This issue relates to which data quality dimension?
Answer: Timeliness
Timeliness refers to the requirement that data be entered promptly after the event; late entry can affect data integrity and regulatory compliance.
Which type of EDC system integration allows lab results to be automatically imported into the eCRF without manual re-entry?
Answer: Laboratory data transfer or HL7 interface
Laboratory data transfers using standards like HL7 or flat-file interfaces allow lab results to flow directly into the EDC system, reducing transcription errors.
During EDC system validation, what document formally captures the tests performed, expected results, actual results, and pass/fail status?
Answer: Validation test script or test execution record
Validation test scripts document each test case with expected and actual outcomes to provide evidence that the system performs its intended functions.
What is the role of an Independent Data Monitoring Committee (IDMC) in relation to EDC data?
Answer: To periodically review unblinded accumulating safety and efficacy data to recommend trial continuation or stopping
The IDMC reviews interim unblinded data from the EDC to assess benefit-risk and may recommend stopping or modifying the trial based on safety or futility.
Which CDISC standard is specifically designed for the structure of clinical trial data submitted to regulatory agencies, and is closely linked to how EDC data must ultimately be organized?
Answer: SDTM (Study Data Tabulation Model)
SDTM defines the standard structure for organizing and submitting clinical trial data to the FDA and other regulatory agencies.
A sponsor requires that sites obtain electronic signatures from investigators to confirm data accuracy. Under 21 CFR Part 11, which of the following must accompany an electronic signature?
Answer: The full name of the signer, date and time, and the meaning of the signature
21 CFR Part 11 requires that electronic signatures include the signer's printed name, the date and time signed, and the meaning (e.g., approval, authorship).