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Essential Documentation in Clinical Trials at Research Sites June 2010

Course Description

Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, Best Practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance. 

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Learning Objectives

  • Define clinical research essential documentation
  • Determine essential subject and non-subject specific documentation requirements per trial
  • Discuss essential documentation for drug vs. device vs. combination products
  • Prepare for regulatory inspection: proactive and reactive use of essential documentation

Who Should Attend

  • Clinical Research Coordinators
  • Principal Investigators
  • Research Site Managers
  • CRAs
  • QA Personnel
  • CRA Managers/Project Managers

Instructor 

Sandra SAM Sather, MS, BSN, CCRA, CCRC

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Course Length Time

2 hours; 12:30 - 2:30 p.m. Eastern

Course Dates 

June 1, 2010

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)