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UPCOMING LIVE SEMINARS
 






The GCPs of Essential Documents

Upcoming Courses
Course #: BI11650
June 30, 2014
9:30 AM - 11:00 AM Eastern
$695.00

Course Description

Understanding the big picture of how essential study documents impact the approval and ethics of a clinical research trial often gets overlooked in the rush of document collection and requests. The foundation of this web seminar is the site study file, what the documents are, and why they are important as related to ICH GCP E6 Essential Documents and 21 CFR 50, 54, 56 and 312. This web seminar will also provide a reference point for why the paperwork is so critical within the process of a study.

Learning Objectives

  • Describe the investigational product development process and the role of documentation
  • Discuss the roles and responsibilities during the study document handling process
  • Review the importance of study files and essential documents handling including review of FDA audit findings

Who Should Attend

  • Study Coordinators
  • Site Regulatory Managers
  • Clinical Research Associates
  • Project Assistants
  • Regulatory Assistants
  • Site Managers

Instructor

Nikki Christison, B.S. 

Click here for complete trainer biographies 

Registration Fees

$695

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-12-060-L01-P. Released: 9/12. 

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. 


BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

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Blended Curriculum Path for the CRA, CRC, and Project Manager

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New Titles added every month! 
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Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


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)