COVID-19 Update

All campus visitors must be fully vaccinated (boosted). Masks are highly recommended. Instructors & staff are required to submit a daily symptom check. COVID updates.

Good Clinical Practices | CTDM.X411

Good Clinical Practices | CTDM.X411


Clinical research is governed by a set of broad regulatory requirements, industry standards and recommendations. Interpreting and implementing these “best practice” standards presents a challenge for all the stakeholders involved in human research. This course explores the framework and principles of Good Clinical Practice (GCP) as it relates to the roles and responsibilities of various stakeholders like the FDA, Investigator, Sponsor, IRB and the study subject. Through lectures, homework, quizzes and the final exam, you will gain knowledge of regulations (federal, state and local) and learn to apply the principles of GCP.

Skills Needed


  • To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Learning Outcomes


At the conclusion of the course, you should be able to
  • Describe the fundamental principles of Good Clinical Practices (GCP)
  • Discuss the roles and responsibilities of key players and stakeholders as it relates to Human Subject Protection
  • Explain the principles of GCP to answer questions arising from everyday clinical research situations
  • Identify various regulations that directly or indirectly impact GCP

Topics Include

  • Regulations, Standards and Principles
  • Sponsors and Protocol
  • Institutional Review Board and HIPAA
  • Study Documentation, Source Data and Test Article
  • Quality Management (Monitoring)
  • Patient Recruitment, Financial Disclosure and Compliance

Notes


Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.
Have a question about this course?
Speak to a student services representative.
Call (408) 861-3860
FAQ
ENROLL EARLY!
This course is related to the following programs:

Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Units Cost Instructor
09-01-2022 to 10-27-2022 3.0 $740

Jeaneen C Wallis

Enroll

Schedule

Date: Start Time: End Time: Meeting Type: Location:
Thu, 09-01-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE
Thu, 09-08-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE
Thu, 09-15-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE
Thu, 09-22-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE
Thu, 09-29-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE
Thu, 10-06-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE
Thu, 10-13-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE
Thu, 10-20-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE
Thu, 10-27-2022 6:00 p.m. 9:30 p.m. Live-Online REMOTE

What students are saying

"I would argue that your certificate program is no less but better than most degreed programs."
— Kristina Liu, PhD. ACRP-CP/CPM Clinical Research Coordinator, Byers Eye Institute, Stanford University
Kristina Liu, PhD.  ACRP-CP/CPM
"I just want to thank you for the amazing class on the GCP research process. I enjoyed the many real life examples you provided throughout the course. I found this to be very helpful. Dr. Wallis is an excellent speaker and communicator."
— Dita Papraniku Clinical Dietician
Dita Papraniku