All About Clinical Research Part B

Scheduled Classes

All About Clinical Research Part a and ICH/GCP Training
04/28/2018 - 04/29/2018
Waterstone
4751 Best Road, Suite 400B
Atlanta, GA 30337
899.00
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Registration
View our scheduled dates to the right to register online or call 678-600-5649. 

Description of Course
This training is designed to provide the participant with an excellent introduction to clinical research and the roles and responsibilities of Clinical Research Associates, Clinical Research Coordinators, and Data Managers. It will explore topics and hands-on knowledge relevant to those considering a career as an entry-level monitor, site coordinator, or data manager. Additionally, this course is appropriate for individuals currently working in the role as monitor, study coordinator/research nurse, or data manager, and are wishing to receive additional training to improve the quality of their sites' research.

Who Should Attend

  • Aspiring Clinical Research Coordinators
  • Aspiring Clinical Research Associates In-house or Field-based
  • Aspiring Clinical Data Managers
  • College Students/ Graduates
  • Nurses, Study Coordinators, Regulatory Coordinators, Clinical Research Associates

You will learn to

  • Discuss the Concept of Good Clinical Practices
  • Recognize the IRB approval Process and Informed Consent Process
  • Discuss the Pre-study Process
  • Review Study Documentation
  • Discuss the Role of the Clinical Team in Monitoring Visits
  • Review Drug Accountability
  • Report and Manage Adverse Events
  • Discuss the Close -Out Visit
  • Review Quality Assurance Audit Trends

 

Course Outline

Day One 8:30 AM 5:00 PM

  • Clinical Research Overview
  • Concept of Good Clinical Practices
  • The IRB approval Process and Informed Consent Process
  • The Pre-study Process
  • Study Documentation
  • Exercise Interaction 1

Day Two 10:00 AM 5:00PM

  • Monitoring Visits
  • Drug Accountability 
  • Managing and Reporting Adverse Events
  • Close-Out Visits
  • Quality Assurance Audit Trends
  • Exercise Interaction 2