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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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* 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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