Good Clinical Practice (GCP) Training programs

Goal: To educate the audience on the special requirements required to effectively recruit and maintain minority enrollment in clinical trials.  The program will also provide a forum for naïve clinical researchers to enhance their knowledge of clinical drug research and to understand the clinical protocol review process so that they can effectively compete for clinical research funding.  

Contact gfykes@healingourvillage.com for more information.

Cost: $100 per participant ( Minimum class size: 10)

Introduction - Overview of the Drug Development 

• The drug development process
  
• Clinical development
  
• Regulation of the pharmaceutical industry
  
• Regulation of Clinical research
  
• Investigator Responsibilities
  

Safeguarding Subjects in Clinical Trials 

• Safety in clinical trials
  
• Adverse events
  
• Reporting adverse events
  
• Data and Safety Monitoring Board
  
• Managing adverse events
  

Planning & Preparation 

• Planning for a clinical trial
  
• Developing  your in-office team
  
• Preparing for the pre-trial visit
  
• Budgeting and Contract 
  
• Obligations to the Sponsor
  
• IRB submission
  

Recruitment and Enrollment 

• Recruitment
  
• Enrollment
  
• Informed consent
  
• Entering subjects into the study
  
• Randomization 
  

The Conduct of the Trial

• Study documentation
  
• Data Collection
  
• Study activities
  
• Investigational product
  
• Retention and compliance
  

Monitoring, Audits, Inspections - Dr. Owen Garrick

• Quality
  
• Monitoring 
  
• Audits and Inspections 
  
• Publications
  

Download PDF of GCP workshop - Module 3