Podcast
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?
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?
What is the level of FDA involvement in non-drug clinical trials?
What is the level of FDA involvement in non-drug clinical trials?
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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Description
Test your knowledge on ethical submission in clinical trials and the process of clearance by the USA IRB. Explore the timing of opinion release, FDA involvement, and non-drug related aspects. Challenge yourself with this informative quiz!
