Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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Trial Procedures Flashcards

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

Read the first 7 Trial Procedures flashcards as text

  1. What is the primary purpose of source data verification (SDV) during a monitoring visit?

    Answer: To confirm that data recorded in the CRF accurately reflects the original source documents

    SDV ensures that CRF data accurately reflects source documents, maintaining data integrity and regulatory compliance.

  2. Which GCP principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?

    Answer: The ALCOA principle

    The ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) defines the required qualities for clinical trial data.

  3. A clinical trial subject reports a new medication they started taking. What is the CTA's first responsibility?

    Answer: Record the concomitant medication in the subject's trial records and assess potential interactions per protocol

    Concomitant medications must be documented in trial records and evaluated for protocol compliance and potential interactions.

  4. What is the standard requirement for retaining essential documents after the completion of a clinical trial under ICH E6?

    Answer: At least 2 years after the last approval of a marketing application or at least 2 years after formal discontinuation

    ICH E6 requires essential documents to be retained for at least 2 years after the last marketing application approval or 2 years after formal discontinuation.

  5. During a clinical trial, an investigator wants to make a change to the protocol before receiving sponsor and IRB approval. What should the CTA advise?

    Answer: The change cannot be implemented until the sponsor approves an amendment and the IRB approves the change

    Protocol changes require sponsor and IRB/ethics committee approval before implementation, except in cases of immediate safety concerns.

  6. What is 'double data entry' used for in clinical trials?

    Answer: Having two different operators independently enter the same data to identify and reduce transcription errors

    Double data entry involves two independent operators entering the same data so discrepancies can be identified and corrected to improve accuracy.

  7. What is a 'washout period' in a crossover clinical trial design?

    Answer: A period between treatment phases during which the effects of the previous treatment are allowed to dissipate

    A washout period is a specified time between crossover treatments to ensure the first treatment's effects do not carry over into the second phase.