Practice Test Geeks(CRA) Certified Research Associate Practice Test
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EDC & CDMS Systems Flashcards

7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 EDC & CDMS Systems flashcards as text

  1. What is an eCRF (electronic Case Report Form)?

    Answer: A structured electronic form within an EDC system used to collect and record subject data per protocol requirements

    An eCRF is the digital equivalent of a paper CRF, built within the EDC platform to capture subject-level data according to the protocol's data collection requirements.

  2. Which of the following is a key component of 21 CFR Part 11 compliance for EDC systems?

    Answer: Use of secure, computer-generated, time-stamped audit trails that record operator entries and actions

    21 CFR Part 11 requires that electronic records maintain secure, computer-generated, time-stamped audit trails that cannot be disabled or modified by regular users.

  3. A data manager identifies a pattern of out-of-range lab values at one site that are consistently being manually overridden with 'data verified' comments. What should this trigger?

    Answer: A site audit or for-cause monitoring visit to investigate potential data integrity issues

    Systematic override of edit checks without adequate justification is a data integrity signal that warrants a for-cause investigation, potentially including an audit or targeted monitoring visit.

  4. What is a 'validation environment' in the context of EDC system development?

    Answer: A separate, controlled system instance used to test EDC builds and changes without affecting live production data

    A validation environment mirrors the production EDC but contains only test data, allowing developers and QC teams to test new builds, edit checks, and changes before pushing them live.

  5. In a CDMS, what is the difference between a 'hard edit' and a 'soft edit'?

    Answer: A hard edit prevents saving a record until the issue is resolved; a soft edit allows saving but generates a query or warning

    Hard edits are blocking rules that prevent data submission until corrected, while soft edits are non-blocking warnings that allow saving but flag the issue for review.

  6. Why must all EDC software used in clinical trials be validated?

    Answer: To demonstrate that the system consistently performs according to its specifications and produces reliable, accurate data suitable for regulatory submissions

    EDC validation (under 21 CFR Part 11 and GCP) demonstrates that the system reliably captures, processes, and stores data as intended, supporting the integrity of clinical trial data submitted to regulators.

  7. Which document outlines all the data fields, forms, visits, and validation rules to be programmed in the EDC for a specific study?

    Answer: Edit Check Specification (ECS) / eCRF Specification

    The Edit Check Specification (or eCRF/database specification) details every form, field, validation rule, and skip pattern to be built into the EDC for a given study.