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Audits, Monitoring, and Inspections Flashcards

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

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  1. Which element is MOST critical for an audit trail in an electronic data capture (EDC) system to satisfy GCP requirements?

    Answer: A time-stamped record of all original entries, changes, and deletions with user identification

    GCP requires that electronic systems maintain a time-stamped audit trail capturing who made each entry or change and when, without obscuring original data.

  2. A CAPA (Corrective and Preventive Action) plan issued after an audit finding should include all of the following EXCEPT:

    Answer: Signatures from the FDA district office approving the plan

    CAPAs are developed and approved internally by the sponsor or site; FDA district office signature is not a component of a standard CAPA document.

  3. During a risk-based quality management (RBQM) approach, what are 'critical data' and 'critical processes'?

    Answer: Those that have a significant impact on subject safety and the reliability of trial results

    ICH E6(R2) defines critical data and processes as those whose integrity is essential to protecting subjects and ensuring the reliability of trial results.

  4. If an investigator receives a Notice of Inspection from the FDA and is given a date for an inspection, which action is INAPPROPRIATE?

    Answer: Altering or backdating any records to correct apparent gaps

    Altering, falsifying, or backdating records is illegal and constitutes obstruction; it can result in criminal prosecution and disqualification.

  5. The FDA's Bioresearch Monitoring (BIMO) program inspects all of the following EXCEPT:

    Answer: Health insurance companies processing subject claims

    BIMO inspects clinical investigators, sponsors/CROs, IRBs, and in-vitro diagnostic manufacturers, but health insurers are not part of this program.

  6. An investigator is disqualified by FDA under 21 CFR Part 312.70. What is the primary effect of this action?

    Answer: The investigator is prohibited from receiving investigational drugs and conducting FDA-regulated studies

    FDA disqualification under 21 CFR 312.70 bars the investigator from receiving investigational drugs and participating in FDA-regulated research.

  7. Which monitoring approach involves a targeted review of a predefined percentage of source data rather than reviewing every data point?

    Answer: Statistical sampling-based SDV

    Statistical sampling-based SDV reviews a defined subset of data points, often guided by risk assessment, rather than verifying every CRF entry against source documents.