CT: Science of Clinical Trials Design

This course reviews the nuts-and-bolts of effective clinical trial design and the basic anatomy of a clinical trial. Topics include trial designs by stage in drug/device development; the various types of trial designs and when they apply; defining the hypothesis and study objectives; defining clinically meaningful safety and efficacy endpoints and study procedures; selecting the study population and determining sample size; scientific/ethical considerations; and data analyses and statistical considerations.

Other Credits: BRN: 24 CE hours.

Note: Prerequisite: The Drug Development Process, FPM 40173. Elective for Professional Certificate in Clinical Trials Design and Management.

Course Number: FPM-40205
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management

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7/10/2023 - 9/9/2023

$645

Online

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• SECTION ID:

  172693

• CLASS TYPE:

  Online Asynchronous.
  
  This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
  You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

• INSTRUCTOR:
  

  Paillard, Florence C, Scientific and Medical Writer for the biopharmaceutical industry

  Florence Paillard is a scientific and medical writer for the biopharmaceutical industry. Working within R&D, clinical and marketing fields, she acquired experience in writing many types of documents, from scientific and review papers to regulatory documents to marketing communications. She is currently a free-lance scientific and medical writer.

• TEXTBOOKS:

  No textbook required.

• POLICIES:

• NOTE:

  ***STUDENTS MAY ENROLL ANYTIME IN QUARTER, until August 4, 2023. Students must complete course by September 9, 2023,regardless of date of enrollment***Refund deadline : One week after enrollment

• DATE & LOCATION:

  7/10/2023 - 9/9/2023
  extensioncanvas.ucsd.edu
  You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.