Practice Test Geeks(CLE) Certified Lactation Educator Practice Test
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Good Clinical Practice & ICH Guidelines Flashcards

7 cards from real CLE 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. Under ICH GCP, a 'qualified' investigator in a lactation clinical trial is defined as one who is:

    Answer: A person responsible for the conduct of the trial at a trial site with appropriate education, training, and experience

    GCP defines the investigator as the person responsible for conducting the trial at the site, with education, training, and experience appropriate for that responsibility.

  2. A data safety monitoring board (DSMB) in a lactation clinical study is convened primarily to:

    Answer: Periodically review accumulating safety and efficacy data and recommend continuation, modification, or termination

    A DSMB independently reviews accumulating trial data at intervals to safeguard participant safety and the validity of the study.

  3. In GCP terminology, 'blinding' or 'masking' in a lactation research study refers to:

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

    Blinding is a GCP technique where subjects, investigators, or others are kept unaware of treatment assignments to prevent bias in study conduct and assessment.

  4. According to ICH E6, which party bears ultimate responsibility for the quality and integrity of trial data?

    Answer: The sponsor, who has overall accountability for the trial

    Under GCP, the sponsor retains ultimate responsibility for the overall quality and integrity of the trial data, even when tasks are delegated to a CRO.

  5. A lactation researcher is also a treating clinician for study participants. Under GCP, this dual role creates a risk of:

    Answer: Therapeutic misconception, where participants conflate research with personal medical care

    Therapeutic misconception occurs when participants fail to distinguish the purpose of research from that of individualized medical care, a key GCP ethical concern.

  6. ICH GCP requires that all individuals involved in conducting a clinical study be:

    Answer: Adequately qualified by education, training, and experience to perform their respective tasks

    GCP requires that all study personnel have qualifications appropriate to their specific tasks, verified through education, training, and experience records.

  7. In a multi-site lactation study, GCP requires that a single Institutional Review Board (sIRB) or central IRB be used for U.S. sites primarily to:

    Answer: Streamline oversight, reduce duplication, and improve efficiency of IRB review under the 2018 NIH sIRB policy

    The 2018 NIH sIRB policy and 2018 Common Rule revision require single IRB review for U.S. multi-site studies to reduce redundancy and improve efficiency.