Clinical Trials Design and Management Certificate

Pharmaceutical drug and medical device development is one of the premier industries of the twenty-first century. San Diego is now considered a world leader and one of the top centers for biotech in the world. The success of this vital industry depends upon the complex process of studying new products to verify their effectiveness and their safety--the clinical trial. Since its inception in 1997, with the help of a highly-qualified and prestigious advisory board & instructors who are cutting-edge industry professionals, UC San Diego Extension’s Professional Certificate in Clinical Trial & Design Management trains professionals at all levels in this vibrant and stimulating field. Students are able to customize their program by choosing an emphasis of study through a grouping of “topics” for a mastery of skills in diverse clinical trial areas.

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Certificate Course Matrix
Course Title	Course Number	Units	FA	WI	SP	SU
Prerequisites
Introduction to Clinical Research	FPM-40270	1	O	O	O	O
Medical Terminology	FPM-40172	1	O	O	O	O
Required Courses
Drug Development Process	FPM-40173	3	O	O	O	O
Human Subjects Protection and IRBs	FPM-40388	2	S	S	S
Good Clinical Practices	FPM-40204	3		S		S
Electives (14 units are required)
Clinical / Scientific Topics
Science of Clinical Trials Design	FPM-40205	3	O	O	O	O
Drug Safety: Surveillance and Reporting	FPM-40206	2			S
Nuts and Bolts of Monitoring Clinical Trials	FPM-40187	2	O	O	O	O
Advance Nuts and Bolts of Monitoring Clinical Trials	FPM-40240	2				S
Medical Writing: Protocols, Reports, Summaries, and Submissions	FPM-40188	2	O		O
Understanding Oncology	FPM-40493	3	O	O	O	O
Monitoring Oncology Trials	FPM-40494	3	O	O	O	O
Regulatory Topics
Prospective Preparation for Internal and External Audits	FPM-40207	1				S
Good Laboratory Practices	BIOL-40085	2	O	O, X		O
Good Manufacturing Practices	BIOL-40000	3	O	O	O	O
Regulatory Compliance for Drugs & Biologics	BIOL-40101	2	O, X	O	O	O
Project Management topics for sponsors of clinical trials
Clinical Study Implementation and Management	FPM-40229	2	O	O	O	O
Data Management Systems for Sponsors of Clinical Trials	FPM-40218	2		S
Design of Source Documents and Case Report Forms	FPM-40238	2				X
Site and Investigator Recruitment	FPM-40208	1	S
Working with Clinical Research Organizations (CROs)	FPM-40228	1	O	O	O	O
Project management topics for clinical trials sites
Patient Recruitment for Clinical Trials	FPM-40191	1				S
Implementing the Clinical Study: Doing It Right	FPM-40219	2				X
Site Data Management	FPM-40261	2				S
Setting Up a New Clinical Study	FPM-40179	2	O	O	O	O
Topics related to the environment surrounding clinical trials
Financial Management of Clinical Trials	FPM-40338	1	O	O	O	O
Pharmaco-Economics and Effectiveness Trials	FPM-40209	2	S
Introduction to International Clinical Trials	FPM-40496	1	O	O	O	O
Preceptorship in Clinical Trials	FPM-40230	1	X	X	X	X
L=La Jolla M=Mission Valley O=Online R=Rancho Bernardo S=Sorrento Mesa X=Location TBA

Certificate Programs

To Register in the Certificate Program

Certificate registration is required to complete the program. Candidates are encouraged to register in the certificate program as early as possible to take advantage of program benefits. See Certificate FAQs for more information.

Certificate Section ID:	073904	Register Now!
Application Fee:	$50
Contact:	Healthcare, Behavioral Sciences, (858) 964-1016
E-mail:	dmstern@ucsd.edu

Program Benefits

Grounds participants in professional principles upon which clinical trials are based

Provides opportunity to develop, practice, and apply skills most beneficial on the job

Builds confidence to assume more responsible roles within the industry

Certificate Guidelines

The three required courses have no substitutes, and cannot be waived. Recommended: The Drug Development Process to be taken first, after any prerequisites. The 14 elective units may be chosen from any/all elective categories in the matrix. Contact Donna Stern at dmstern@ucsd.edu for guidance.

State Requirements

Those pursuing the Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRA) credentials through ACRP can fulfill educational requirements by completing this program. Individuals seeking the designation of Certified Clinical Research Professional, "CCRP," from The Society of Clinical Research Associates (SoCRA), who hold an Associate's Degree or Bachelor’s degree in science, health science, pharmacy, or a related (science/healthcare) field, may complete the UC San Diego Extension Clinical Trials Design & Management Certificate Program in lieu of one year of SoCRA’s eligibility requirement of two years’ work experience in clinical research. For more information about the CCRP designation, please visit The Society of Clinical Research Associates.

Advisors

Jan Agee
Training Manager andInstructor
Quintiles

Barbara Bigby, M.A., CIP
Director, Scripps Clinic GEN3
Scripps Office for the Protection of Research Subjects

Lynne Eddy, Ph.D.
Consultant

David Shapiro, M.D., ChB, MRCP
Chief Medical Officer
Idun Pharmaceuticals, Inc.

Robin Smith, R.N., BSN, CCRA
Director, Global Critical Quality and Training
Allergan Pharmaceuticals

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