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. The principle of data integrity in GCP-compliant lactation research requires that study records be:

    Answer: Attributable, legible, contemporaneous, original, and accurate (ALCOA)

    GCP data integrity standards require records to be Attributable, Legible, Contemporaneous, Original, and Accurate — the ALCOA principle.

  2. In a lactation study, if an entry error is discovered in the case report form (CRF), GCP requires the correction to be made by:

    Answer: Drawing a single line through the error, initialing, dating, and writing the correct value

    GCP mandates that CRF corrections preserve the original entry — a single strikethrough with initials, date, and correct value maintains the audit trail.

  3. According to ICH E6, the investigator's brochure (IB) in a lactation clinical study is best described as:

    Answer: A compilation of clinical and nonclinical data about the investigational product relevant to its study in humans

    The Investigator's Brochure is a document containing all available clinical and nonclinical information about the investigational product to guide investigators.

  4. A sponsor monitoring a lactation study under GCP oversight is primarily responsible for:

    Answer: Overseeing the conduct of the trial to ensure data integrity, subject safety, and protocol compliance

    Under GCP, the sponsor oversees the entire trial to ensure it is conducted, recorded, and reported in accordance with the protocol, GCP, and regulations.

  5. ICH E6 distinguishes between 'essential documents' and other study records. Essential documents are those that:

    Answer: Individually and collectively permit evaluation of the trial conduct and quality of data produced

    Essential documents are defined as those that individually and collectively allow evaluation of the conduct of a trial and the quality of the data generated.

  6. When a lactation study protocol is amended after IRB approval, the amendment must be submitted to and approved by the IRB before:

    Answer: Implementation of the change, except for immediate action needed to eliminate hazard to subjects

    GCP requires prior IRB approval of protocol amendments before implementation, unless immediate action is required to protect subjects from harm.

  7. GCP requires that clinical trial records, including those from lactation studies, be retained for at minimum:

    Answer: As defined in the protocol and applicable regulatory requirements (often 15+ years)

    GCP and applicable regulations typically require retention of clinical trial records for at least 15 years, or as specified by regulatory authorities and the protocol.