Participants leave the program with an appreciation of the drug and device development process; as well as good clinical practice (GCP) and other regulations (ICH and FDA) that guide the conduct of trials and protect human volunteers. Also covered are clinical trial phases and design strategies; the importance of informed consent and the role of the IRB; investigator selection and responsibilities; study site management and trial monitoring; statistical data analysis; and regulatory responsibilities and the role of the FDA.
This course benefits anyone working in the biopharmaceutical and medical device industries and the biomedical community who is interfacing with or conducting clinical research, including new clinical research associates and study coordinators, medical directors, physicians, nurses, pharmacists, and other health professionals, biomedical scientists, statisticians and database administrators, and business professionals.
A team of clinical research experts, including many instructors from the UCSC Extension Clinical Trials Design and Management Certificate Program, address the following:
- Drug and Medical Device Development Processes
- Clinical Trial Design
- Applied Statistics in Clinical Trials for the Non-Statistician
- Regulation of Clinical Research
- Roles and Responsibilities of Key Clinical Research Players
- Monitoring Clinical Trials
- Clinical Data Management
- Clinical QA, Auditing and Compliance
- GMP and the Transition to Full Scale Manufacturing
- Business of Clinical Research
- Globalization of Clinical Research
Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.
- Save Your Seat
Help us confirm course scheduling. Enroll at least seven days before your course starts.
- Accessing Canvas
Learn more about gaining access to your course on Canvas in our FAQ section.
Accessibility and Accommodation
For accessibility questions or to request an accommodation, please visit Access for Students with Disabilities or email the Extension registrar.
Finance Your Education
Here are ways to pay for your education.
Estimated Cost: TBD
Course Availability Notification
Please use this form to be notified when this course is open for enrollment.
Speak to a student services representative.
Call (408) 861-3860