Clinical Trials Course Schedule

 This chart outlines the program curriculum and annual schedule. Click here to read course details and enroll.
 19-unit minimum ■ = classroom   O = online   ▲ = hybrid
☐ = both online and classroom sections available
Prerequisite Courses Units Course Fall Winter Spring Summer
Medical/Clinical Terminology 0.7 CEU 2928 ■ ■   ■
Human Physiology in Health and Disease 3.0 6999 ■ ■    

 

Required Courses (6) Units Course Fall Winter Spring Summer
Drug Development Process 2.0 6559 ■ ■ ■
Medical Devices: Regulatory Strategies and Marketing Pathways 1.5 5939 ■   ■
Good Clinical Practices 3.0 0458 ■ ■  
Clinical Trials Site Monitoring I 2.0 0608 ■ ■ ■ ■
Science of Clinical Trials Design 2.5 3657 ■ ■
Clinical Statistics for Non-Statisticians 2.0 2345 ■ ■    

 

Elective Courses (6 units required) Units Course Fall Winter Spring Summer
Adverse Event and Medication Coding: An Introduction to MedDRA®, and WHO-Drug 1.5 19976 O  O O O
Case Report Forms Development 1.0 5544 ■    
Clinical Data Management 2.0 6291     ■
Clinical Project Management 2.0 2315   ■
Clinical Research: The Study Site Perspective 1.5 18994 O O O O
Clinical Trials Site Monitoring II 1.5 2687     ■
Compliance with 21 CFR Part 11: Electronic Records, Signatures and Software Validation 1.5 19362 ■   ■  
Contracting with Contract Research Organizations (CROs) 1.5 5479   ■
Development of Clinical Standard Operating Procedures 1.5 1270   ■    
Document Preparation: Protocols, Reports, Summaries 1.5 2636   ■
Drug Safety and Adverse Events Reporting 1.0 3990     ■
Electronic Data Capture for Clinical Trials 1.0 20777   ■    
Global Conduct of Clinical Trials 1.5 20787 ■  
Good Manufacturing Practices 3.0 6328   ■   ■
Medical Writing 2.0 4451 ▲ ▲
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5 5168   ■  
SAS Programming for Clinical Trials 3.0 4670   ■    
SAS for Clinical Trials for the Non-Programmer, Introduction 3.0 2988 ■      

 

Also Recommended Units Course Fall Winter Spring Summer
New! Data Privacy and Security for Healthcare and Biosciences 1.5 30120   ■   ■

 

Also of Interest Units Course Fall Winter Spring Summer
Biology of Cancer 0.5 6630 O    
Clinical Trials Essentials: An Intensive One-Week Course 3.5 CEU 5433   ■  
Viruses, Vaccines, and Gene Therapy 1.5 6974     ■

 

Free Events Units Course Fall Winter Spring Summer
Biosciences Program Presentation: Biotechnology and Bioinformatics   16649 ■ ■
Clinical Trials, Regulatory Affairs, and Medical Devices Program Presentation   16650 ■ ■
Bioscience Program Information and Q&A Session   22402   ■ ■  


Note: Any one course from UCSC Extension's Regulatory Affairs Certificate Program may be applied toward the elective unit requirement for the Clinical Trials Design and Management Certificate.

Individual courses may be taken without enrolling in the full certificate. Course schedule is subject to change, but reflects the current quarter and the anticipated schedule for the next three quarters. Check individual course descriptions for the latest scheduling information.

Biosciences