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Questions and Answers
Which one of the following statements accurately describes the process of ethical submission in a clinical trial?
Which one of the following statements accurately describes the process of ethical submission in a clinical trial?
- Ethical submission is only necessary for drug-related clinical trials.
- Ethical submission is a lengthy process that involves multiple stages of review. (correct)
- Ethical submission is not required for clinical trials in the USA.
- Ethical submission is solely the responsibility of the FDA.
When does the USA IRB typically release its opinion on a clinical trial?
When does the USA IRB typically release its opinion on a clinical trial?
- The opinion is released during the trial.
- The opinion is released after the trial is completed.
- The opinion is never released to the public.
- The opinion is released before the trial begins. (correct)
What is the level of FDA involvement in non-drug clinical trials?
What is the level of FDA involvement in non-drug clinical trials?
- The FDA is not involved in non-drug clinical trials.
- The FDA only provides guidance for non-drug clinical trials. (correct)
- The FDA is responsible for ethical submission in non-drug clinical trials.
- The FDA has the same level of involvement in non-drug clinical trials as in drug-related trials.
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Study Notes
Ethical Submission in Clinical Trials
- Ethical submission in a clinical trial involves obtaining approval from an Institutional Review Board (IRB) before conducting the trial.
IRB Opinion Release
- The USA IRB typically releases its opinion on a clinical trial within a timeframe that is not specified in the protocol, but may vary depending on the complexity of the trial and the completeness of the submitted materials.
FDA Involvement in Non-Drug Clinical Trials
- The FDA's level of involvement in non-drug clinical trials is generally less than in drug trials, but still requires adherence to FDA regulations and guidelines, especially if the trial involves a device or biologic that is subject to FDA approval.
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