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  • Berkeley Global

Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities

PB HLTH X400.3

41824
Delivery Options Hybrid and Online

The second in a series of four courses, this course covers the processes and procedures inherent to planning clinical trials, including protocol development, case report form design, IRB submission, site selection, developing and negotiating site contracts and budgets, pre-study visits, statistics in clinical trials, data management and capture, and electronic records.

Course Outline

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Course Objectives

  • Understand the general principles of clinical research and biostatistics
  • State the crucial role of biostatistics in clinical trial design, data analyses and reporting
  • List the common terms used in biostatistics applicable to clinical trials such as hypothesis testing, endpoints, target population, sample size, confidence interval, etc.
  • Discuss the data management plan and how it is developed
  • Describe how a clinical trial database is set up and validated
  • Define the purpose of a protocol and identify the required contents
  • Describe the types of case report forms and the parameters for designing case report forms (CRFs)
  • Define the required elements of informed consent and describe the process for administering informed consent
  • Understand the elements of a clinical trial agreement and their regulatory and business implications
  • Identify the tools and resources to develop a site budget
  • Understand the development and negotiating process for finalizing contracts and budgets
  • List the activities to be performed for the selection of qualified investigators, staff and investigational site
  • Describe the procedures for conduct and follow-up of pre-study visits
  • Describe the regulations, issues and other considerations in conducting studies in the global arena, with a detailed look at the move toward harmonization
  • Provide references to governing regulatory requirements, guidelines and best practices
  • Understand the IRB submission process and required documents
  • Understand the regulations and guidelines for electronic records and signatures

What You Learn

  • Biostatistics
  • Data management
  • Clinical trial content and process
  • Electronic records
  • Case report forms
  • Data plan development
  • Database setup and validation
  • Informed consent and investigators
  • IRB submission
  • Selecting investigators, staff and site
  • Developing and negotiating site budgets
  • Site contracts
  • Pre-study visit

How You Learn

  • Online lectures
  • Reading assignments
  • Discussions
  • Written assignments
  • 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 066

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

  • Karim Sajwani

Section 067

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

  • Betiel Haile

Section 068

Oct 23, 2021 to Dec 18, 2021 Live Online

Course Fee(s)

Course Fee credit (3 units)

$2,015.00


Section Schedule

Oct 23, 2021 to Dec 18, 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 1:00PM Pacific Time

Dates

Oct 23, 2021

Type Live Online

Days

Sa

Time

9:00AM to 3:30PM Pacific Time

Dates

Nov 06, 2021

Type Live Online

Days

Sa

Time

9:00AM to 3:00PM Pacific Time

Dates

Nov 13, 2021

Type Live Online

Days

Sa

Time

9:00AM to 3:00PM Pacific Time

Dates

Nov 20, 2021

Type Live Online

Days

Sa

Time

9:00AM to 3:00PM Pacific Time

Dates

Dec 04, 2021

Type Lecture

Days

Sa

Time

9:00AM to 3:30PM Pacific Time

Dates

Dec 18, 2021

Schedule and Location

View Details

Instructional Hours

45.00

Delivery Options

Hybrid

Available for Credit

3 semester units

Instructors

  • Marianna Lenoci
  • Karen A. Henry
  • Bonnie Miller
  • Siu Po Sit
  • James Smith

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

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Course Fee

Online

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.

Course Fee

Betiel Haile

Betiel Hadgu Haile, MPH, CCRP, has over 12 years of clinical research experience globally both in the pharmaceutical and device industry. Over the years, she worked with sponsors as well as CRO managing studies. Most of her career has been spent managing drug trials (all phases) and IVD device trials. She has experience with domestic and international studies and has worked in a variety of therapeutic areas, including infectious diseases, oncology, and neurology. She had led sponsor and site FDA audits. Betiel is a subject matter expert in implementing electronic informed consent, clinical trial management system, and electronic trial master file. She is currently a Study Manager at Roche Molecular Systems. Since 2009, Betiel has been an active member of SoCRA (Society of Clinical Research Associates), and has been invited to present at SoCRA Conferences. 

Course Fee

PB HLTH X400.3 - 068 - Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities

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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.

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.

Bonnie Miller

Bonnie Miller, M.S., R.N., is president of BMQCR, Bonnie Miller Clinical Research Consulting, LLC; and vice president-elect, NCA Chapter ACRP. Previously director of clinical standards and training for Elan Pharmaceuticals, she has 18 years of clinical research experience in many sectors of industry after a 15-year nursing career.

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.
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