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Informed Consent Flashcards

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

Read the first 6 Informed Consent flashcards as text

  1. What is the minimum time a subject should be given to consider participating in a clinical trial before signing the informed consent?

    Answer: There is no specific minimum time, but the subject must have sufficient time to consider participation

    ICH-GCP does not specify a minimum waiting period but requires that the subject be given sufficient time and opportunity to inquire about details of the trial and to decide whether to participate.

  2. In an emergency situation where a subject cannot give consent and no LAR is available, what does ICH-GCP recommend?

    Answer: The subject may be enrolled if the protocol has IRB/IEC-approved provisions for emergency consent exception

    ICH-GCP Section 4.8.15 allows enrollment without prior consent in emergency situations if the protocol and IRB/IEC-approved procedures provide for such exceptions, and consent is obtained as soon as possible.

  3. What is the investigator's responsibility regarding subjects who withdraw their consent during a clinical trial?

    Answer: Respect the withdrawal, discontinue trial procedures, and offer the option to allow use of already-collected data

    When a subject withdraws consent, the investigator must respect the decision, stop trial procedures, and may ask whether the subject agrees to allow continued use of data already collected, but cannot compel it.

  4. Which element is NOT typically required in an informed consent form according to ICH-GCP?

    Answer: The total number of sites participating in the trial

    While the informed consent must include risks, alternative treatments, and injury compensation information, the total number of trial sites is not a required element under ICH-GCP Section 4.8.10.

  5. What documentation is required when a subject provides oral consent but is physically unable to sign the written consent form?

    Answer: An impartial witness must attest to the subject's oral consent by signing and dating the form

    When a subject can understand and consent verbally but cannot physically sign, an impartial witness must be present, verify the subject's oral consent, and sign and date the form on the subject's behalf.

  6. What is an assent form and when is it used in clinical research?

    Answer: A simplified consent document used to obtain agreement from minors or individuals with diminished capacity

    An assent form is a simplified document used to obtain the agreement of a minor or a person with diminished decision-making capacity to participate in research, in addition to the consent obtained from their LAR.