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Fast Facts

Investigator responsibilities and Legal commitments in Drug and Device Clinical Research:

Sep 14,2011 - Sep 14,2011
Online Event, Palo Alto, California, United States
 

Highlights

Why Should You Attend:

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.

This training, by a physician investigator with 20+ years experience, will cover the regulations for both drug and device clinical research in a user friendly way.

Areas Covered in the Seminar:

  • The Investigators key role in the clinical research process.
  • How following GCP helps assure a clean Audit / inspection?
  • The difference between AEs and SAEs and the reporting requirements.
  • What are the main Investigator responsibilities?
  • How is the investigator is responsible for the IC process?
  • What is the legal language of the FDA form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?

 

   Note : Add another webinar to your shopping cart and get 20% off on its price.

For More Details:

http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=702063?channel=gtm











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Event Profile

Sponsors: ComplianceOnline
Speakers: Charles H. Pierce
Attendees: Principal Investigators and sub investigators,Safety Nurses,Clinical Research Associates,

Contact Details

Contact person: Satrughna Pradhan
Event website: http://bit.ly/pi4waK
Phone: +1-650-620-3915
Fax: +1-650-963-2556

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