CT: Prospective Preparation for Internal and External Audits

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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7/3/2023 - 7/28/2023

$325

Online

Closed

• SECTION ID:

  172698

• 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:
  

  Olson, Suzan, Formative/Summative Usability/Human Factors Testing in Medical Device and Combination Products

  Suzan Olson works with manufacturers to plan and execute human factors evaluations and clinical trials covering pediatrics and adults of combinations products and medical devices. She earned a doctorate in psychology and a master's in health administration from Wichita State University as well as a bachelor's in health administration from Ottowa University. She is also a registered nurse.

• TEXTBOOKS:

  No textbook required.

• POLICIES:

• NOTE:

  Refund deadline: one week after enrollment or start date of section, whichever is later.

• DATE & LOCATION:

  7/3/2023 - 7/28/2023
  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.

10/23/2023 - 11/17/2023

$325

Online

Add To Cart

• SECTION ID:

  174909

• 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:
  

  Olson, Suzan, Formative/Summative Usability/Human Factors Testing in Medical Device and Combination Products

  Suzan Olson works with manufacturers to plan and execute human factors evaluations and clinical trials covering pediatrics and adults of combinations products and medical devices. She earned a doctorate in psychology and a master's in health administration from Wichita State University as well as a bachelor's in health administration from Ottowa University. She is also a registered nurse.

• TEXTBOOKS:

  REQUIRED

  The Fundamentals of clinical Research: A Universal Guide for Implementing Good Clinical Practice 1st
  by Dubinsky, P. Michael & Henry, Karen A
  ISBN / ASIN: 9781118949597

  You may purchase textbooks via the UC San Diego Bookstore.

• POLICIES:

• NOTE:

  Refund deadline: one week after enrollment or start date of section, whichever is later.

• DATE & LOCATION:

  10/23/2023 - 11/17/2023
  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.