Course Description

Diagnostic studies vary greatly from standard pharma and device studies, and the documents generated for these studies differ accordingly. This web seminar presents the basic tools required to generate Clinical Study Reports (CSRs) for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these CSRs, the guidances to follow for reference, basic skills for understanding the data (i.e., false positives, false negatives, and percent agreement), and other diagnostics output and results, as well as coordination with the 510(k) submission.

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Learning Objectives

• Turn the protocol and data into clear concise submission documents
• Describe the elements required for the CSR and how this differs from standard pharma CSRs
• Differentiate between the types of data and their interpretation
• Describe where the CSR fits into a 510(k) submission and some interdependencies

Who Should Attend

• Medical Directors
• Medical Writers
• Clinical Research Associates
• Clinical Scientists
• Regulatory Affairs Professionals
• Research and Development Personnel
• CRO Personnel
• Personnel planning a change from the pharma sector to the diagnostic sector

Instructor

The course will be led by one of the following instructors:

Cheryl Vitow

Click here for complete trainer biographies

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.