Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Good Clinical Practice & ICH Guidelines Flashcards

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Read the first 7 Good Clinical Practice & ICH Guidelines flashcards as text

  1. Under ICH E6(R2), which of the following is NOT considered an essential document that must be in the Trial Master File before the trial begins?

    Answer: Completed Case Report Forms (CRFs)

    Completed CRFs are generated during the trial, not before it begins; they are essential documents maintained during the conduct phase, not the pre-trial phase.

  2. ICH E6(R2) defines 'direct access' in the context of monitoring and auditing as:

    Answer: Permission to examine, analyze, verify, and reproduce trial records

    Direct access means permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of the trial.

  3. Which ICH guideline specifically addresses dose-response information to support drug registration?

    Answer: ICH E4

    ICH E4 — 'Dose-Response Information to Support Drug Registration' — provides guidance on study designs to characterize dose-response relationships.

  4. An investigator delegates a trial task to a sub-investigator. Under GCP, what document must capture this delegation?

    Answer: The delegation log (also called signature log or delegation of authority log)

    The delegation log formally records which tasks the investigator has delegated to sub-investigators or other site staff, with signatures and dates.

  5. According to ICH E6(R2), an Investigator's Brochure (IB) must be updated:

    Answer: At least annually or more frequently if significant new safety information emerges

    The IB must be reviewed and updated at least once a year, and more often if new information significantly affects subject safety.

  6. In a GCP-compliant trial, source document verification (SDV) by a CRA primarily serves to:

    Answer: Confirm that CRF data accurately reflect the source data

    SDV ensures that data transcribed or entered into the CRF (or EDC) match the original source records, maintaining data integrity.

  7. Under ICH E6(R2), the Quality Management System (QMS) framework introduced in the R2 addendum emphasizes which key concept?

    Answer: Identifying and controlling risks to critical data and processes

    The R2 addendum's QMS framework centers on identifying risks to critical processes and data, then implementing proportionate controls to manage those risks.