This course provides a step-by-step outline of internal and external audits as well as ongoing actions that should be taken to prepare for an audit. Topics include types of audits; the audit process (sites, sponsors, CROs); planning/preparing for an audit; rules of behavior during and after the audit; and dealing with the results.
Other Credits: BRN: 8 CE hours.
Note: Prerequisite: Good Clinical Practices (FPM 40204 or equivalent) or 2 years clinical research experience. Elective for Professional Certificate in Clinical Trials Design and Management.
Course Number: FPM-40207
Credit: 1.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management
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4/22/2024 - 5/17/2024
$325
Online
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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.
Morton, James
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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NOTE:
Refund deadline: one week after enrollment or start date of section, whichever is later.
4/22/2024 - 5/17/2024
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.
There are no sections of this course currently scheduled. Please contact the Healthcare & Behavioral Sciences department at 858-534-9262 or unexhealthcare@ucsd.edu for information about when this course will be offered again.