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Course

CT: Science of Clinical Trials Design

FPM-40205

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.

Course Information

Online
3.00 units
$645.00
Notes: Prerequisite: The Drug Development Process, FPM 40173. Elective for Professional Certificate in Clinical Trials Design and Management.

Course sessions

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Section ID:

185935

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.

Textbooks:

No textbook required.

Policies:

Schedule:

No information available at this time.
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Instructor: James Morton

James Morton
Dr. James Morton received his doctorate of pharmacy degree form the University of Southern California. He is a Senior clinical research professional with over a decade of experience in clinical operations as a consultant, with AbbVie and Therapeutics Incorporated and over a decade of experience in clinical development with Quest Diagnostics. He has developed specific expertise in planning, implementation, oversight, monitoring, project management and completion of clinical studies. His work as lead to successful FDA approvals for three BOTOX indications; glabella lines, hyperhidrosis and migraine headache. Additionally he has supported successful clinical validations of over 50 LDT, including EUA for Quest COVID-19 At-Home Rapid Antigen Test.
 
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