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  • Berkeley Global

Introduction to Clinical Research: Clinical Trial Phases and Design

PB HLTH X400.2

41823
Delivery Options Online

Gain a solid foundation in clinical research by reviewing the drug development process, the principles of good clinical practice, clinical trial phases and design, the principal players in clinical research and regulatory oversight of medical devices.

Course Outline

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Course Objectives 

  • Understand the overall drug development process
  • Identify the stages of drug development
  • Describe and decipher medical terms 
  • Describe the principles of good clinical practice, as well as regulations and guidelines applicable to clinical trials
  • List and describe the clinical phases of drug development
  • Discuss post-marketing drug trials
  • Discuss the roles of the FDA and ICH
  • Describe the role and responsibilities of clinical trial investigators, clinical trial sponsors and contract research organizations (CROs)
  • Understand the constitution, roles and responsibilities of institutional review boards (IRBs) and independent ethics committees (IECs) with regard to human subject research
  • Understand the relationships between sponsors and vendors such as CROs
  • Understand clinical trial design considerations
  • Discuss the role of evidence-based medicine in trial designs
  • List the components of investigational new drug (IND) applications, and describe the application development and submission processes
  • Describe regulatory guidelines for medical devices and medical device clinical trials

How You Learn

  • Multimedia lectures
  • Reading assignments
  • Research discussion forums and assignments
  • Written assignments
  • Review quizzes
  • Midterm and final exams

Is This Course Right for Me?
This class is geared for those who are new to clinical trials and to those entering the clinical research field.

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Sections

Section 088

Jan 03 to Feb 28

Type: Online, Fixed Date

Instructor:

  • Louis X. Wong

Cost: $2,015.00

See section 088 Details

Type Online, Fixed Date

Dates

Jan 03, 2024 to Feb 28, 2024

Instructional Hours

45.00

Delivery Options

Online

Available for Credit

3 semester units

Section 089

Jan 06 to Feb 24

Type: Live Online

Instructor:

  • Marianna Lenoci
  • Karen A. Henry
  • Thomas Renau
  • Siu Po Sit

Cost: $2,015.00

See section 089 Details

Section Schedule

Jan 06, 2024 to Feb 24, 2024

Type Live Online

Days

Sa

Time

9:00AM to 3:30PM Pacific Time

Dates

Jan 06, 2024

Location

Live Online

Type Live Online

Days

Sa

Time

9:00AM to 3:30PM Pacific Time

Dates

Jan 20, 2024

Location

Live Online

Type Live Online

Days

Sa

Time

9:00AM to 3:30PM Pacific Time

Dates

Feb 03, 2024

Location

Live Online

Type Live Online

Days

Sa

Time

9:00AM to 2:30PM Pacific Time

Dates

Feb 10, 2024

Location

Live Online

Type Live Online

Days

Sa

Time

9:00AM to 3:00PM Pacific Time

Dates

Feb 24, 2024

Location

Live Online

Schedule and Location

View Details

Instructional Hours

45.00

Location

Live Online

Delivery Options

Online

Available for Credit

3 semester units

Section 087

Mar 06 to May 01

Type: Online, Fixed Date

Instructor:

  • Karim Sajwani

Cost: $2,015.00

See section 087 Details

Type Online, Fixed Date

Dates

Mar 06, 2024 to May 01, 2024

Instructional Hours

45.00

Delivery Options

Online

Available for Credit

3 semester units

Spring enrollment opens on October 16!

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


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.

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Berkeley, CA 94704-7000

extension@berkeley.edu

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The University of California, Berkeley, is accredited by the Western Association of Schools and Colleges (WASC). UC Berkeley Extension—like all other UC Berkeley schools, colleges and departments—is accredited by WASC through the University.

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Course Fee

Louis X. Wong

Louis X. Wong, MS ACRP-CP has over 8 collective years of clinical and research experience in clinical industry drug development, academic clinical research, and academic pre-clinical research. He is currently a Clinical Trial Manager, managing clinical trials in-house and providing oversight of vendors and all other aspects in Phase I-III trials. With expertise in Sponsor-Initiated, Investigator-Initiated, Collaborative, and Cooperative studies, he has worked in a variety of indications and therapeutic areas, such as oncology, in-vitro diagnostics, and infectious diseases. Louis holds a B.A. in Molecular and Cell Biology, with an emphasis in Cell and Developmental Biology, Medical Biology and Physiology, from UC Berkeley, M.S. in Clinical and Translational Research from The George Washington University School of Medicine and Health Sciences, and a Ph.D. Student in Translational Health Sciences at The George Washington University School of Medicine and Health Sciences.

Online

Course Fee

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.

Karen A. Henry

Karen Henry, M.P.H., is a clinical research consultant and has worked for 20 years in industry and academic health institutions in the areas of Good Clinical Practice principles and regulations, clinical trials management, standard operating procedures development and management, and clinical quality compliance.

Thomas Renau

Tom Renau, Ph.D. received his BS in Biology from UC Irvine and PhD in Medicinal Chemistry from University of Michigan. He has worked in the Pharmaceutical industry for over 20 years in areas spanning from lead discovery to marketed products both regionally and globally. He has held positions at both small and large companies in the Bay Area including Roche, Genentech, Onyx and Pharmacyclics with assignments on brands including Avastin, Rituxan and Kyprolis. He currently is Vice President of Medical Strategy at Vaniam Group LLC. He has been an Instructor with UC Berkeley Extension since 1997.

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.

PB HLTH X400.2 - 089 - Introduction to Clinical Research: Clinical Trial Phases and Design

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Course Fee

Karim Sajwani

KARIM SAJWANI, M.P.H., CCRA, Director Global Clinical Operations at Santen, has more than 21 years of experience in clinical drug development in cardiovascular, dermatology, infectious disease, oncology, ophthalmology and respiratory areas. Previously, he was a senior clinical program manager at Gilead Sciences where he oversaw management of all aspects of Phase I-III global clinical trials and has led projects through several new drug applications (NDA) and supplemental NDAs. Prior to that, he was a clinical research manager at Abbott and a clinical trial manager at Genentech.

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