Registration Rate:
Regular Registration Fee: $590
ACS/Gov Registration Fee: $
Cancellation Fee: $
Registration Policy
Register Now Online
|
Continuing Education Credit:
ACPE: 708-000-08-992-H03-P/T - 1.5 CEU
Initial Release Date: 11/10/08
CME: 15 Hours of Category 1 Credit
VNA: 07-04-01 15 Contact Hours
Continuing Education Policy
|
Course Description:
This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH. You should expect to spend approximately 15 hours of study time to complete the course. You will have a four-month access after you register for the course.
|
Who Should Attend:
This course is designed for individuals who need an introduction to the conduct, monitoring, and/or the quality assurance of clinical trials. Those working in quality assurance, regulatory compliance, or clinical research, including clinical research associates, medical monitors, and others working in the pharmaceutical research environment, may benefit from this course.
|
Educational Objectives:
- Discus the history and evolution of GCPs
- Interpret FDA regulations and ICH guidelines pertaining to GCPs
- Identify the regulatory, source documentation, and record-keeping requirements for clinical trials
- Describe the components of internal auditing systems
- Distinguish the roles and responsibilities of sponsor, monitor, investigator, and regulatory authorities in ensuring the proper conduct of clinical trials
- Apply GCP principles to the collection and reporting of adverse events
|
Key Topics:
- Regulatory Environment in the US
- International GCP Regulations and ICH Guidelines
- IRB/Ethics Committee Responsibilities
- Investigator Responsibilities
|
- Sponsor Responsibilities
- The Protocol
- Sponsor Obligations
- Monitoring Responsibilities
- Clinical Quality Assurance (CQA) Group
- FDA Inspections
- Managing FDA Inspections
|
|
|
Contact Course Manager:
Course Manager
|
