Practice Test Geeks(CTA) Clinical Trial Associate Certification Practice Test
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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. ICH E6(R2) requires that informed consent be obtained before which of the following?

    Answer: Before any trial-specific procedures are performed

    GCP mandates that informed consent must be obtained prior to any trial-specific screening or treatment procedures being conducted.

  2. Which ICH guideline provides guidance on statistical principles for clinical trials, including randomization and blinding?

    Answer: ICH E9

    ICH E9 — 'Statistical Principles for Clinical Trials' — covers randomization, blinding, analysis populations, and handling of missing data.

  3. In the context of ICH E6(R2), 'source data' is defined as:

    Answer: All information in original records and certified copies of original records

    Source data includes all original records (paper or electronic) and certified copies that contain clinical trial information.

  4. Under GCP, what action must an investigator take when a protocol deviation that may affect subject safety occurs?

    Answer: Report it promptly to the sponsor, IRB/IEC, and regulatory authority as required

    Protocol deviations affecting subject safety must be promptly reported to the sponsor, IRB/IEC, and regulatory authorities according to applicable requirements.

  5. Which ICH guideline establishes the general considerations for clinical development planning, including dose-finding and early phase studies?

    Answer: ICH E8

    ICH E8 — 'General Considerations for Clinical Trials' — outlines the overall development framework including early phase, dose-finding, and confirmatory trials.

  6. When is it permissible under ICH E6(R2) for a legally acceptable representative (LAR) to provide consent on behalf of a subject?

    Answer: When the subject is unable to give personal informed consent due to incapacity

    An LAR may consent when a subject lacks capacity to provide personal consent (e.g., due to cognitive impairment or emergency), provided applicable regulatory requirements are met.

  7. According to ICH E6(R2), sponsor monitoring should be risk-based. Which element is specifically introduced in the R2 addendum to support this approach?

    Answer: Centralized monitoring as a complement to on-site monitoring

    The R2 addendum emphasizes that centralized monitoring can supplement or replace some on-site monitoring based on a risk assessment, improving efficiency without compromising quality.