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Archive: Writing Protocols for Diagnostic Studies

Course #: BI11974
April 15, 2015

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 protocols for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these protocols, how they differ from the standard pharma protocols, the guidances to follow for reference, and the regulatory environment surrounding sample collection and informed consents for de-linked samples.

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Learning Objectives

  • Describe the sample collection process, delinking, and sample handling
  • Differentiate between the requirements of a traditional pharma protocol and a diagnostics protocol
  • Identify the elements required for a sample collection protocol
  • Identify the elements required for an accuracy study protocol
  • Identify the elements required for a reproducibility study protocol
  • Describe the regulatory documents required, and when they are required, including informed consent

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


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.