Registration Rate:
Regular Registration Fee: $590
ACS/Gov Registration Fee: $490
Cancellation Fee: $
Registration Policy
Register Now Online
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Continuing Education Credit:
ACPE: 708-000-08-991-H03-P/T - 1.2 CEU
Initial Release Date: 11/10/08
CME: 15 Hours of Category 1 Credit
VNA: 07-04-01 15 Contact Hours
Continuing Education Policy
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Course Description:
The goal of this course is to provide a practical orientation to site management and monitoring of clinical studies. The course provides a comprehensive overview of clinical monitoring in the context of the overall drug development process; FDA and HPB regulations; and ICH guidelines for GCP. This course will be delivered completely over the Internet, which means you will progress at your own pace through the course content. The course combines text-based study materials with interactive exercises enabling you to apply what you have learned to on-the-job situations. 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.
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Who Should Attend:
This course is designed primarily for clinical research associates new to the industry (first year on the job). It is also beneficial for study coordinators and CRA supervisors who are relatively new to supervising clinical trials.
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Educational Objectives:
Recognize the regulatory basis for monitoring clinical research activities
Carry out site management and clinical monitoring responsibilities from study initiation to study completion
Ensure compliance with informed consent procedures
Maintain the integrity of trial data
Review trial related documents
Outline reporting requriements for adverse events and monitoring them properly
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Key Topics:
- The US Regulated Environment
- The HPB Regulated Environment
- ICH Guidelines
- Informed Consents
- Investigator Selection
- Study Initiation / Investigator Meetings
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- Drug Accountability
- Sample Handling
- Site Management / Visits
- Data Management
- Quality Assurance
- What is an Adverse Event?
- What are the Reporting Requirements of AEs?
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Course Director(s):
Phyllis J. Panico, PhD
Retired Manager of Professional Development
AstraZeneca, LP
Cheryl J. Priest, RN,
Independant Clinical Development Training
and Quality Process Consultant
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Contact Course Manager:
Course Manager
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