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  • Berkeley Global

Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management

PB HLTH X400.5

41826
Delivery Options Online

The last in a series of four courses, this final course focuses on the clinical study report and other procedures at study close-out. You will be prepared to conduct regulatory audits and inspections. You’ll also gain an overview of project management and vendor selection as they pertain to clinical research.

Prerequisites:

Introduction to Clinical Research: Clinical Trial Phases and Design PB HLTH X400.2; Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities PB HLTH X400.3; and Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting PB HLTH X400.4

Course Outline

Expand or collapse section

Course Objectives 

  • Describe how sponsors and CROs may improve regulatory compliance
  • Describe how investigational sites may prepare for regulatory audits, the procedures to expect at an audit, the possible findings and outcomes
  • Understand the role of project management in clinical research
  • Understand the vendor selection process
  • List the sections of a data analysis plan (DAP) and describe how it is developed and finalized
  • Understand data entry, review and cleanup procedures
  • Describe clinical trial data analyses and report writing procedures
  • List the sections of a clinical study report (CSR) and describe how it is developed and finalized
  • Describe the sections of a new drug application (NDA) and the procedures for compiling the sections and filing an NDA.

What You Learn

  • Quality assurance
  • Quality control
  • CQA sponsor perspective
  • Regulator inspections
  • Inspection readiness
  • Project management in clinical trials
  • Vendor selection
  • Study initiation: data management setup
  • Study execution: data collection
  • Post-Study: data analysis and quality assurance
  • Clinical study reports
  • New drug application

How You Learn

  • Multimedia lectures
  • Reading assignments
  • Research discussion assignments
  • In-depth questions
  • Case studies
  • Midterm and final exams
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Sections

Section 078

May 03 to Jun 30

Type: Online, Fixed Date

Instructor:

  • Daniel Redline

Cost: $2,015.00

See section 078 Details

Type Online, Fixed Date

Dates

May 03, 2023 to Jun 30, 2023

Instructional Hours

45.00

Delivery Options

Online

Available for Credit

3 semester units

Section 079

Jul 05 to Aug 30

Type: Online, Fixed Date

Instructor:

  • Venkatesh Gopal

Cost: $2,015.00

See section 079 Details

Type Online, Fixed Date

Dates

Jul 05, 2023 to Aug 30, 2023

Instructional Hours

45.00

Delivery Options

Online

Available for Credit

3 semester units

Summer enrollment opens on March 20!

This course applies to the following programs:

Certificate Program in Clinical Research Conduct and Management

Expand or collapse section

Required Courses

  • Introduction to Clinical Research: Clinical Trial Phases and Design
  • Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities
  • Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting
  • Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management

Courses of Related Interest

  • Pharmacology
  • Genomic Medicine
  • Principles of Toxicology
  • Introduction to Biostatistics
  • The Drug Development Process: An Intensive Seminar
  • Principles of Product and Process Development
  • Principles of Quality and Compliance

Learn More About this Program

Notes

Departmental contact for academic questions: biotech_online@berkeley.edu | (510) 642-1062


Instructional Types

Live Online
Live Online courses provide an interactive learning experience with scheduled synchronous online sessions held via Zoom video conferencing (Pacific Time). Learn more about the Live Online format.
Online, Start Anytime
Continuous enrollment course begins when you enroll. You have a minimum of 90 days and a maximum of 180 days to complete the course.
Online, Fixed Date
Enroll in this course by its start date and complete it by its specified end date. There are no live sessions, but plenty of opportunities to collaborate with your classmates and instructor.
Classroom
Take classes in-person at one of our buildings or partner locations.

English Language Proficiency Requirements

All of our courses are taught in English. If English is not your first language, please use the following test scores as guides in order to be successful:

  • TOEFL: 90
  • IELTS Academic Format: 7
  • DAAD: C1
  • TEM-4 or TEM-8: Level 70
  • Duolingo: 115

Note: You do not need to submit test scores.

Extension

1995 University Ave., Suite 130

Berkeley, CA 94704-7000

extension@berkeley.edu

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Course Fee

Daniel Redline

Dan Redline has over 27 years of combined clinical, regulatory and research experience in the hospital, academic medical center, and industry settings. He is currently the Senior Director of Global Clinical Affairs for Align Technology, a medical device company, and an instructor for the Clinical Research Conduct and Management Program at UC Berkeley Extension. He was previously the Senior Director of Clinical Affairs for NeuroVision Imaging, Senior Clinical Program Manager for Gilead Sciences, Director of the IRB Administration for UC Davis, and Director of Clinical Affairs for Volcano Corporation, and he has held other leadership positions in industry and academia.  He is also certified as a Clinical Research Professional (CCRP). Dan has a BA in Molecular and Cell Biology, with an emphasis in Neurobiology, from UC Berkeley, and he completed graduate course work in the areas of Public Health and Medicine.   

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