Clinical trial development Question Title * 1. What documents does a manufacturer need to submit to regulatory agencies to prepare for a clinical trial (also known as a clinical study)? OK Question Title * 2. What role does the ICMJE have in the development of a drug, device or biologic? OK Question Title * 3. How can you determine the truth of a manuscript written about clinical trials? OK Question Title * 4. Which are the three results section of a clinical study report? Which is the most important and why? OK Question Title * 5. Where can you find freely available summaries of all clinical studies completed for a marketed drug? OK Question Title * 6. When a manufacturer is applying for the marketing of a device, which documents are submitted to the FDA? OK Question Title * 7. Which documents and resources do you need to prepare a clinical study report and its appendices? OK Question Title * 8. How do clinical trials differ for devices, drugs and biologics; how do PSURs and DSURs differ? OK Question Title * 9. Who files an NDA, how and to which organization and how are governments involved? OK Question Title * 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. Name Company Address Address 2 City/Town State/Province -- select state -- AL AlabamaAK AlaskaAS American SamoaAZ ArizonaAR ArkansasCA CaliforniaCO ColoradoCT ConnecticutDE DelawareDC District of ColumbiaFM Federated States of MicronesiaFL FloridaGA GeorgiaGU GuamHI HawaiiID IdahoIL IllinoisIN IndianaIA IowaKS KansasKY KentuckyLA LouisianaME MaineMH Marshall IslandsMD MarylandMA MassachusettsMI MichiganMN MinnesotaMS MississippiMO MissouriMT MontanaNE NebraskaNV NevadaNH New HampshireNJ New JerseyNM New MexicoNY New YorkNC North CarolinaND North DakotaMP Northern Mariana IslandsOH OhioOK OklahomaOR OregonPW PalauPA PennsylvaniaPR Puerto RicoRI Rhode IslandSC South CarolinaSD South DakotaTN TennesseeTX TexasUT UtahVT VermontVI Virgin IslandsVA VirginiaWA WashingtonWV West VirginiaWI WisconsinWY Wyoming ZIP/Postal Code Country Email Address Phone Number OK DONE