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  • Berkeley Global

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

PB HLTH X400.5

41826
Delivery Options Hybrid and 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.

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 061

Apr 03, 2021 to May 15, 2021 Live Online

Course Fee(s)

Course Fee credit (3 units)

$2,015.00


Section Schedule

Apr 03, 2021 to May 15, 2021

Type Live Online

Access classroom-style interactive learning from anywhere in the world! Attend scheduled online sessions with your instructor and classmates in addition to completing your coursework.

Live Online format allows you to take classes from anywhere with an internet connection. Classroom sections will be taught in this format through Spring 2021. Learn more about this format.

Beginning August 15, 2020, you must have a Zoom account to participate.

Many schools are now accepting transfer credit for online coursework, including health and sciences programs. Check with your institution before enrolling.

Days

Sa

Time

9:00AM to 3:30PM Pacific Time

Dates

Apr 03, 2021

Type Live Online

Days

Sa

Time

9:00AM to 3:00PM Pacific Time

Dates

Apr 17, 2021

Type Live Online

Days

Sa

Time

9:00AM to 3:00PM Pacific Time

Dates

May 01, 2021

Type Live Online

Days

Sa

Time

9:00AM to 4:00PM Pacific Time

Dates

May 15, 2021

Schedule and Location

View Details

Instructional Hours

45.00

Delivery Options

Hybrid

Available for Credit

3 semester units

Instructors

  • Marianna Lenoci
  • Kathleen Monroe
  • Siu Po Sit

Section 062

May 06, 2021 to Jul 01, 2021 Online

Course Fee(s)

Course Fee credit (3 units)

$2,015.00


Type 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.

Dates

May 06, 2021 to Jul 01, 2021

Instructional Hours

45.00

Delivery Options

Online

Available for Credit

3 semester units

Instructors

  • Daniel Redline

Section 063

Jul 06, 2021 to Aug 31, 2021 Online

Course Fee(s)

Course Fee credit (3 units)

$2,015.00


Type 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.

Dates

Jul 06, 2021 to Aug 31, 2021

Instructional Hours

45.00

Delivery Options

Online

Available for Credit

3 semester units

Instructors

  • Daniel Redline

This course applies to the following programs:

Certificate Program in Clinical Research Conduct and Management

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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

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

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Course Fee

PB HLTH X400.5 - 061 - Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management

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Hybrid

Marianna Lenoci

Marianna Lenoci, M.A., Extension Honored Instructor, serves as the senior project director for the Post-Traumatic Stress Disorder (PTSD) Research Core of the Mental Illness Research, Education and Clinical Center (MIRECC) at the San Francisco Veterans Affairs Medical Center. She has 10 years of experience managing a number of VA, U.S. Department of Defense, National Institutes of Health and industry-funded research studies in the area of PTSD.

Kathleen Monroe

Kathleen Monroe, B.A., M.B.A., has held positions as vice president of operations, project management and quality assurance and has extensive experience with team management, clinical development and operations functions in the biotech, medical device and pharmaceutical industries. She has worked on global project teams from research through phase IV, and is familiar with product life-cycle management.

Siu Po Sit

Siu Po Sit, Ph.D., is the vice president of clinical affairs responsible for the clinical development of neurovascular devices at Penumbra Inc., where his focus has been on the clinical development of endovascular therapy for the treatment of acute ischemic stroke and intracranial aneurysm.

Course Fee

Online

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.   

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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