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GCP Training for Investigators March 2011

Mar 21, 2011
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Course Description 

This course provides a brief review of new drug development and the clinical trials process as it affects the Investigator, and explains where Good Clinical Practice (GCP) fits in. Relevant sections of the Code of Federal Regulations (CFR), International Conference on Harmonization (ICH), and Form FDA 1572 are discussed in-depth and in relationship to the Investigator’s responsibilities for proper conduct of clinical trials. This course will highlight the 13 principles of ICH GCP as the foundation for all clinical studies, and demonstrate to the Investigator the rationale for sponsor requirements throughout clinical development of an investigational drug.

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Learning Objectives 

  • Identify the key stages of the drug development process
  • Describe the elements involved in the clinical trial process
  • Apply the principles of ICH GCP to current clinical trials
  • Examine the Investigator’s responsibilities in the conduct of clinical trials as required in the regulations (CFR) and guidelines (ICH)
  • Recognize the commitment made in executing the Form FDA 1572

Who Should Attend 

  • Principal Investigators (new) 
  • Seasoned Principal Investigators interested in reviewing responsibilities
  • Sub-Investigators
  • Physicians interested in participating in clinical research
  • Site Research Managers/Directors

Instructor 

Gary B. Freeman, M.S., C.C.R.A., C.C.R.T.

Click here for complete trainer biographies 

Course Length Time 

3 hours; 12:30 – 3:30 p.m. Eastern

Course Dates 

March 21, 2011

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471

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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)