Skip to main content

Update on Remote Instruction Effective March 15, 2023: Changes to vaccination policy. Learn more.

Close
The following fields are required:
Error has occurred. Please reload this page and try the operation again.
  • Agents
  • Student Login
  • Instructor Login
Extension
      • Areas of Study
        • Art and Design
        • Behavioral Health Sciences
        • Business
          • Accounting
          • Business Administration
          • Economics
          • Finance
          • Leadership and Management
          • Marketing
          • Mathematics and Statistics
          • Project Management
          • See the full list
        • Construction and Sustainability
        • Education
        • Humanities and Languages
        • Sciences, Mathematics
          and Biotechnology
          • Biology
          • Chemistry and Physics
          • Clinical Laboratory Science
          • Health Advising
          • Life Science Business and Biotechnology
          • Mathematics and Statistics
          • Online Sciences Courses
          • See the full list
        • Technology and
          Information Management
        • Writing, Editing and
          Technical Communication
      • Transfer Credit
        • Transfer Credit Courses
      • Online Learning
        • Online Courses and Certificates
      • Events
        • Information Sessions
      • Career Services
        • Career-Development Courses
        • Professional Internship Program
      • Custom Programs
        • For Universities and Organizations
      • Academic Services
        • Enrollment
        • Transcripts
        • General Information
        • Community Guidelines
        • Locations
      • Course and Program Information
        • Latest COVID-19 Information
        • Online Course Policies
        • Certificates, Programs and CEUs
        • Concurrent Enrollment
        • International Student Services
      • Student Aid
        • Disability Support Services
        • Financial Assistance
      • Voices
        • Voices Home
        • Educator Insights
        • Student Stories
        • Professional Pathways
        • Industry Trends
      • Events
        • Information Sessions
        • Free and Low Cost Events

  • Berkeley Global

Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting

PB HLTH X400.4

41825
Delivery Options Online

The third in a series of four courses, this course is designed to deepen your knowledge of the processes and procedures to implement clinical trials. The role of clinical trial monitors is highlighted in a detailed review of the various aspects of study monitoring, such as data review, safety reporting and drug accountability. You also review global drug development and issues such as subject recruitment and retention (which are crucial to meeting study timelines and regulatory requirements), site initiation processes, and setting up trial master files and investigator files.

Prerequisites:

Introduction to Clinical Research: Clinical Trial Phases and Design PB HLTH X400.2 and Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities PB HLTH X400.3

Course Outline

Expand or collapse section

Course Objectives

  • List the various regulatory and other necessary documents that are essential before, during and at the end of clinical trials, and how and when they must be collected, reviewed and filed by sponsors and investigators 
  • Describe the procedures for initiating individual investigational sites and for conducting investigator meetings for multi-center trials
  • Understand the potential issues with subject recruitment and retention in studies and the steps that may be taken to improve both
  • Describe the regulations, issues and other considerations in conducting studies in the global arena, with a detailed look at the move toward harmonization 
  • Understand the purpose of monitoring and list the steps involved in conducting routine monitoring visits 
  • Describe the data-review process during monitoring in terms of CRF review and source document verification (SDV)
  • Discuss the importance of drug accountability and describe the necessary procedures for drug accountability by the investigational site, monitor and sponsor
  • Understand what adverse and serious adverse events are
  • Discuss the importance of adequate safety reporting, and the required timelines, documentation, and procedures for recording and reporting safety data 
  • Describe the processes involved in individual site close-out and at study close-out 
  • Provide references to governing regulatory requirements, guidelines and best practices


What You Learn

  • Trial master files
  • Investigator files
  • Document collection, review and filing
  • Site initiation steps and checklist
  • Subject recruitment rate
  • Overcoming subject drop-outs
  • Global drug development environment
  • Harmonization of regulations and guidelines
  • Routine monitoring visit checklist
  • Data review process (case report forms and source document verification)
  • Study drug accountability procedures and documentation
  • Adverse and serious adverse events
  • Site close-out
  • Post-study review

How You Learn

  • Lectures
  • Reading assignments
  • Online discussions
  • Written assignments
  • Midterm and final exams
Loading...

Sections

Section 080

May 03 to Jun 30

Type: Online, Fixed Date

Instructor:

  • David R Leonard

Cost: $2,015.00

See section 080 Details

Type Online, Fixed Date

Dates

May 03, 2023 to Jun 30, 2023

Delivery Options

Online

Available for Credit

3 semester units

Section 081

Jul 05 to Aug 30

Type: Online, Fixed Date

Instructor:

  • David R Leonard

Cost: $2,015.00

See section 081 Details

Type Online, Fixed Date

Dates

Jul 05, 2023 to Aug 30, 2023

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

Facebook Facebook Icon Twitter Twitter Icon LinkedIn LinkedIn Icon YouTube YouTube Icon Instagram Instagram Icon Medium Small Icon for Medium
WeChat QR code

Locations

  • Berkeley
  • San Francisco
  • Online
  • Other

Resources

  • About Us
  • Career Services
  • Administration
  • Accessibility
  • Nondiscrimination
  • Privacy
  • Transcripts
  • Gifts
  • Jobs
  • Contact Us
Western Association of Schools and Colleges

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.

Copyright © UC Regents

Powered by Destiny One

Cookie Policy

By clicking “Accept All Cookies,” I agree to permit this website to share my information, including a device identifier and my browsing history on this site, with selected partners, including Google, Meta/Facebook and others, to enhance my browsing experience and to ensure that marketing communications are targeted to my needs in accordance with our Cookie Policy and our Privacy Policy.

Session Time-Out

For security reasons and the protection of your personal information, your session will time out due to a period of inactivity in minute(s) and second(s). Click Extend My Session to continue. For security reasons and the protection of your personal information, your session timed out after a period of inactivity. You will be redirected to the home page.

Confirm

Alert

Course Fee

David R Leonard

David R. Leonard, M.A., P.A., D.H.Sc., has practiced clinically in the acute-care setting and has been a physician assistant educator and associate director for more than 10 years with Saint Francis University and Pace University—Lenox Hill Hospital Physician Assistant Programs. Most recently, he has been teaching online courses in a Master of Health Science and Master of Medical Science program. For almost a decade, Leonard has been involved in the clinical research industry as a clinical research associate (CRA). His specialty is in the interventional cardiology device and vascular fields.

Online

Course Fee

David R Leonard

David R. Leonard, M.A., P.A., D.H.Sc., has practiced clinically in the acute-care setting and has been a physician assistant educator and associate director for more than 10 years with Saint Francis University and Pace University—Lenox Hill Hospital Physician Assistant Programs. Most recently, he has been teaching online courses in a Master of Health Science and Master of Medical Science program. For almost a decade, Leonard has been involved in the clinical research industry as a clinical research associate (CRA). His specialty is in the interventional cardiology device and vascular fields.

Processing...

Privacy Policy

Cookie Policy

This statement explains how we use cookies on our website. For information about what types of personal information will be gathered when you visit the website, and how this information will be used, please see our Privacy Policy.

How we use cookies

All of our web pages use "cookies". A cookie is a small file of letters and numbers that we place on your computer or mobile device if you agree. These cookies allow us to distinguish you from other users of our website, which helps us to provide you with a good experience when you browse our website and enables us to improve our website.

We use cookies and other technologies to optimize your website experience and to deliver communications and marketing activities that are targeted to your specific needs. Some information we collect may be shared with selected partners such as Google, Meta/Facebook or others. By browsing this site you are agreeing to our Privacy Policy. You can revoke your voluntary consent to participate in monitored browsing and targeted marketing by selecting “Disable All Cookies” below.

Types of cookies we use

We use the following types of cookies:

  • Strictly necessary cookies- these are essential in to enable you to move around the websites and use their features. Without these cookies the services you have asked for, such as signing in to your account, cannot be provided.
  • Performance cookies- these cookies collect information about how visitors use a website, for instance which pages visitors go to most often. We use this information to improve our websites and to aid us in investigating problems raised by visitors. These cookies do not collect information that identifies a visitor.
  • Functionality cookies- these cookies allow the website to remember choices you make and provide more personal features. For instance, a functional cookie can be used to remember the items that you have placed in your shopping cart. The information these cookies collect may be anonymized and they cannot track your browsing activity on other websites.

Most web browsers allow some control of most cookies through the browser settings. To find out more about cookies, including how to see what cookies have been set and how to manage and delete them please visit https://www.allaboutcookies.org/.

Specific cookies we use

The list below identify the cookies we use and explain the purposes for which they are used. We may update the information contained in this section from time to time.

  • JSESSIONID: This cookie is used by the application server to identify a unique user's session.
  • registrarToken: This cookie is used to remember items that you have added to your shopping cart
  • locale: This cookie is used to remember your locale and language settings.
  • cookieconsent_status: This cookie is used to remember if you've already dismissed the cookie consent notice.
  • _ga_UA-########: These cookies are used to collect information about how visitors use our site. We use the information to compile reports and to help us improve the website. The cookies collect information in an anonymous form, including the number of visitors to the website, where visitors have come to the site from and the pages they visited. This anonymized visitor and browsing information is stored in Google Analytics.

Changes to our Cookie Statement

Any changes we may make to our Cookie Policy in the future will be posted on this page.