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* 1. What documents does a manufacturer need to submit to regulatory agencies to prepare for a clinical trial (also known as a clinical study)?

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* 2. What role does the ICMJE have in the development of a drug, device or biologic?

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* 3. How can you determine the truth of a manuscript written about clinical trials?

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* 4. Which are the three results section of a clinical study report? Which is the most important and why?

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* 5. Where can you find freely available summaries of all clinical studies completed for a marketed drug?

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* 6. When a manufacturer is applying for the marketing of a device, which documents are submitted to the FDA?

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* 7. Which documents and resources do you need to prepare a clinical study report and its appendices?

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* 8. How do clinical trials differ for devices, drugs and biologics; how do PSURs and DSURs differ?

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* 9. Who files an NDA, how and to which organization and how are governments involved?

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* 10. Would you like to know the answers to all these questions? The Medical Writing Institute hopes you enjoyed the quiz and will visit us online,  http://medicalwritinginstitute.us.

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