Question:
According to Good Clinical Practice, informed consent must be
According to Good Clinical Practice, informed consent must be
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Good Clinical Practice (GCP) is the ethical and scientific standard for designing and conducting clinical trials.
Updated On: Jun 24, 2026
- Obtained only after completion of the trial
- Written, voluntary and obtained before trial participation
- Taken only in Phase III trials
- Waived if the investigator considers the drug safe
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The Correct Option is B
Solution and Explanation
Concept:
Good Clinical Practice (GCP) is the ethical and scientific standard for designing and conducting clinical trials. Protecting the rights, safety and well-being of trial subjects is its central principle, and informed consent is a cornerstone of that protection.
Step 1: Under GCP, informed consent must be written, voluntary, and obtained before the subject takes part in any trial-related activity. The subject must understand the study and freely agree, with no coercion.
Why the other choices are wrong: Consent cannot be taken after the trial, cannot be limited to only Phase III, and can never be waived simply because an investigator believes the drug is safe. All of these violate basic ethical requirements.
Answer: Option (2) — Informed consent must be written, voluntary and obtained before participation. (2)
Good Clinical Practice (GCP) is the ethical and scientific standard for designing and conducting clinical trials. Protecting the rights, safety and well-being of trial subjects is its central principle, and informed consent is a cornerstone of that protection.
Step 1: Under GCP, informed consent must be written, voluntary, and obtained before the subject takes part in any trial-related activity. The subject must understand the study and freely agree, with no coercion.
Why the other choices are wrong: Consent cannot be taken after the trial, cannot be limited to only Phase III, and can never be waived simply because an investigator believes the drug is safe. All of these violate basic ethical requirements.
Answer: Option (2) — Informed consent must be written, voluntary and obtained before participation. (2)
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