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August 21, 2022

FDA Transparency of Clinical Trial

Read the following:

Go to following website and Search Diabetes as the keyword in the search bar. Go the last page of the listing and click on HMR1964A_3506, trial with published results. This will launch the Sanofi corporate website which will describe their results sharing policy. In order to see an actual CSR you must establish an account which is optional for this module. Clinical Study Data Report: https://clinicalstudydatarequest.com(Links to an external site
FDA Transparency of Clinical Trial Information: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm592566.htm (Links to an external site.)
Preparing for and Disseminating Trial Resultshttps://www.fhi360.org/sites/default/files/media/documents/CommhandbkChapterSix.pdf (Links to an external site.)
http://www.dcvmn.org/IMG/pdf/7_structure_and_content_of_clinical_study_reports.pdf (Links to an external site.)

Reference Materials (but will be required for the quiz)

https://www.fda.gov/media/71271/download

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