Good Clinical Practice Curriculum

Overview of the Clinical Research Process
This course is designed to give an understanding of the new drug, biologic and device approval process and the significance of how important it is to develop products that meet regulatory requirements for global registrations. California Board of Nursing Program Number: 11147-2004-CBT-213 — (1 Contact Hour/Credit)

Learning objectives include:

• Recognize the definition of drugs
• Recognize the definition of biologics
• Recognize the definition of devices and the classes of devices
• Identify the definition and purpose of the CFR
• Recognize the definition and purpose of the EU Directives
• Identify the definition and purpose of the ICH guidelines
• Recognize the definition of GCP
• Identify how GCP principles are defined according to the CFR, ICH guidelines, and the EU Directives
• Recognize the definitions for an IND, NDA, BLA, IDE, PMA, 510(k), and CTD
• Recognize the phases of clinical research
• Be aware of the overall timelines and costs
• Be aware of the timelines and costs for non-clinical trials
• Be aware of the timelines and costs for clinical trials
• Recognize the elements of documentation assembly
• Identify the process for regulatory approval

Faculty/Disclosure: Richard Guarino, MD, indicates that he has no relationship with the commercial industries to disclose relative to the content of the CME activity.

Ethics as the Foundation of Clinical Research
This course examines current ethical issues in clinical research with a focus on ethical principles in historical and current regulations. California Board of Nursing Program Number: 11147-2004-CBT-210 — (1 Contact Hour/Credit)