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Principal Investigator Oversight and the Appropriate Delegation of Tasks September 2011

Course Description

Principal Investigators (PIs) are required to provide adequate oversight of all clinical research activities at the site, whether the activity is conducted by the PI, by study team members, or by applicable third parties. Adequate oversight encompasses many activities and obligations, such as ensuring regulatory compliance, staff training, and subject medical care. In this web seminar, we will discuss the regulatory requirements and guidance regarding adequate investigator oversight and appropriate delegation of study tasks, review documentation requirements, and determine strategies for appropriate delegation of tasks.

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Learning Objectives

  • Recognize the industry concerns about adequate delegation and improper delegation of study activities
  • Identify documentation requirements for proper delegation and investigator oversight
  • Identify strategies for determining role assignment specific to a study project and requirements of PI oversight

Who Should Attend

  • Site Research Managers
  • Investigators
  • Clinical Research Associates/Monitors
  • Study/CRA Managers
  • Clinical Research Coordinators
  • Sponsors/CROs

Instructor

Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.

Click here for complete trainer biographies 

Course Length Time

1.5 hours; 9:00 – 10:30 a.m. Eastern

Course Dates

September 27, 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!
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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)