SEARCH

UPCOMING LIVE SEMINARS
 






Final FDA Guidance for Supervisory Responsibilities of Investigators: What Made it Through and How It Affects Sites and Sponsors February 2011

Feb 16, 2011
Order the DVD of this seminar

Course Description 

This course presents content and impact discussion of the now FINAL FDA human subject protection guidance document posted in May 2007 and approved October 2009. The guidance document addresses definitions of adequate supervision, appropriate oversight and delegations, adequate training, proper credentialing by principal investigators, and reasonable medical care and access to appropriate care for study subjects. The seminar addresses how the guidance provides long awaited counseling on activities of the principal investigator regarding working with their study team and how the guidance impacts greatly on the role of the sponsor in qualifying and monitoring the research site.

VideoPreview

 

Learning Objectives 

  • Recognize the history of the guidance draft and final releases
  • Analyze the two major content areas of the guidance for the clarification of certain investigator responsibilities
  • Examine implications on site and sponsor activities
  • Explore case scenarios: recent warning letters and more

 Who Should Attend 

  • Clinical Research Investigators
  • Clinical Research Coordinators
  • Clinical Research Associates
  • Managers
  • Quality Assurance

Instructor 

Sandra "SAM" Sather, MS, BSN, CCRA, CCRC

Click here for complete trainer biographies 

Course Length Time 

1.5 hours; 12:00 - 1:30 p.m. Eastern

Course Dates 

February 16, 2011

mail ACPE statements within three weeks of program completion.  ACPE#: 778-000-09-053-L04-P. Released: 1/10.                                               

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

FOLLOW US ON: 

LinkedIn twitter Facebook 


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. 

Jan - July 2014 Edition

Winter CatalogDownload Today!  

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

BCP Cover

Download Today! 

 

 

 


 

DVD IconWEB SEMINAR ARCHIVE 

 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


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)