#Barnett
Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.
Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).
Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.
Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.
Archive: Writing Clinical Study Reports for Diagnostic Studies
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.
Video Preview
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.