This program is an intensive course designed for clinicians who
will be assuming principal investigator responsibilities for clinical trials.

Upon completion of this course, clinicians will be competent and possess the valuable skills needed in order to conduct a well organized and controlled clinical research study within their institution and/or private practices.

Sample Agenda

9:00-9:15: Introductions

9:15-10:00: The Drug Development Process:
Types of Research
Clinical Research: How Do We Accomplish this Goal?
Phases of Clinical Research
Common Obstacles

10:00-10:45: Principal Investigator Responsibilities  
What is a Principal Investigator (PI)?
FDA Form 1572
GCP Guidelines for Investigators  

10:45-11:00: BREAK  

11:00-12:00: FDA Regulations in Clinical Research
Title 21 CRF ????? Food and Drug Administration  

Reviewed Parts  

CFR Part 11: Electronic Records; Electronic Signatures
CFR Part 50: Protection of Human Subjects
CFR Part 54: Financial Disclosure by Clinical Investigators
CFR Part 56: Institutional Review Boards
CFR Part 312: Investigational New Drug Application  

Parts Not Reviewed  
CFR Part 314: Application for FDA Approval to Market A New Drug
CRF Part 320: Bioavailability and Bioequivalence Requirements
CFR Part 601: Licensing
CFR Part 812: Investigational Device Exemptions
CFR Part 814: Premarket Approval of Medical Devices  

12:00-12:15: ICH Guidelines for Good Clinical Practice  
What Is GCP and How Do They Differ from FDA Regulations?  

12:15-1:00: Informed Consent  
What is Informed Consent?
FDA Requirements (Sample ICF Review)
Developing an Informed Consent Form  

1:00-2:00: LUNCH    

2:00-2:45: The Clinical Research Protocol  
FDA/GCP Requirements
Working with the Clinical Research Protocol
Protocol Deviations
Protocol Compliance  

2:45-3:15: Understanding Adverse Events  
What is an Adverse Event?
What is a Serious Adverse Event?
Documenting and Reporting Adverse Events  

3:15-3:30: Source Documentation  
What are Source Documents?
Examples of Source Documents Used in Clinical Research
How to Maintain Adequate Source Documentation
What are Sponsor Companies Looking For?    

3:30-3:45: BREAK      

3:45-4:00: Essential Documents  
What are Essential Documents?
FDA/GCP Regulatory Requirements
Maintaining Essential Documents
Communicating and Corresponding with the IRB  

4:00-4:30: Non-Compliance, Fraud and FDA Suspension  

4:30: Questions/Discussion  

Call or contact us online for course availability and pricing information. Fee includes handbook of materials presented, FDA regulations, Basic Good Clinical Practices

 

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Call or contact us online for course availability and pricing information. Fee includes handbook of materials presented, FDA regulations, Basic Good Clinical Practices

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