Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
← All CTA Flashcard Decks

Good Clinical Practice & ICH Guidelines 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 Good Clinical Practice & ICH Guidelines flashcards as text

  1. Which ICH guideline addresses the structure and content of clinical study reports (CSRs) submitted to regulatory authorities?

    Answer: ICH E3

    ICH E3 — 'Structure and Content of Clinical Study Reports' — specifies the format and content requirements for CSRs submitted for marketing applications.

  2. Under GCP, what is the investigator's primary responsibility regarding drug accountability at the clinical site?

    Answer: Maintaining accurate records of delivery, inventory, dispensing, and return or destruction of investigational product

    The investigator (or designee) must maintain precise IP accountability records covering receipt, inventory, dispensing to subjects, and return or destruction.

  3. ICH E6(R2) requires that changes to source data in paper records be made how?

    Answer: By crossing out the original entry with a single line, dating, initialing, and providing a reason if needed

    GCP requires that corrections leave the original legible, crossed out with a single line, then dated, initialed, and explained if necessary, maintaining an audit trail.

  4. Which of the following best describes the concept of 'blinding' (masking) in the context of ICH GCP?

    Answer: A procedure in which one or more parties are unaware of treatment assignments to reduce bias

    Blinding (masking) means that one or more parties (subject, investigator, sponsor, or assessor) do not know which treatment a subject is receiving, reducing potential bias.

  5. Under ICH E6(R2), how should an investigator handle an emergency situation where a subject cannot provide consent but needs investigational treatment?

    Answer: Enroll the subject and obtain retrospective consent, following applicable laws

    In life-threatening emergencies, GCP permits treatment without prior consent if allowed by applicable regulations, provided consent is obtained as soon as possible afterward.

  6. Which ICH guideline provides recommendations for ethnic factors in the acceptability of foreign clinical data during new drug applications?

    Answer: ICH E5

    ICH E5 — 'Ethnic Factors in the Acceptability of Foreign Clinical Data' — addresses how to evaluate and bridge foreign clinical data considering ethnic differences.

  7. Under GCP, when a clinical trial is terminated early by the sponsor, the investigator must:

    Answer: Promptly notify the IRB/IEC and regulatory authorities and ensure subject safety follow-up

    Upon early termination, the investigator must promptly inform the IRB/IEC, comply with regulatory requirements, and ensure appropriate care and follow-up for enrolled subjects.