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
What is the primary purpose of a User Acceptance Testing (UAT) phase before an EDC system goes live?
Answer: To verify that the configured system meets all protocol requirements before use in the actual trial
UAT confirms that the EDC system's build correctly reflects the protocol requirements and performs as expected before actual subject data is entered.
Under GDPR, which principle requires that personal data collected in an EDC system be limited to what is necessary for the specified purpose?
Answer: Data minimization
GDPR's data minimization principle mandates that only the minimum amount of personal data necessary for the trial's stated purpose be collected.
Which of the following is a key advantage of EDC over paper-based data collection in multi-site clinical trials?
Answer: Provides real-time central monitoring of data completeness and quality
EDC enables sponsors and CROs to monitor data quality and completeness across all sites in real time, supporting risk-based monitoring strategies.
When a data manager performs 'medical coding' within or alongside an EDC system, what is the primary tool used to code adverse events?
Answer: MedDRA (Medical Dictionary for Regulatory Activities)
MedDRA is the internationally recognized medical terminology dictionary used to code adverse events and medical history in clinical trial databases.
A site coordinator changes a previously entered lab value and provides a reason for the change. In a compliant EDC system, the original value should be:
Answer: Retained in the audit trail alongside the corrected value and reason
21 CFR Part 11 and GCP require that original entries are never deleted; the audit trail must preserve the original value, the change, and the reason.
In EDC configuration, a 'skip logic' or 'branching logic' rule is used to:
Answer: Hide or show eCRF fields based on responses to previous questions
Skip logic dynamically shows or hides form fields based on previous answers, preventing irrelevant data entry and reducing errors.
What is the significance of an EDC system being '21 CFR Part 11 compliant' for FDA-regulated trials?
Answer: It means electronic records and signatures are legally equivalent to paper records and handwritten signatures
21 CFR Part 11 compliance means the electronic records and electronic signatures generated by the system are legally accepted by the FDA as equivalent to traditional paper records.