SEARCH

UPCOMING LIVE SEMINARS
 






Risk-Based Decisions in Clinical Trial Site Management November 2010

Dec 3, 2010
Order the DVD of this seminar

Course Description 

All clinical trial teams, sponsors/CROs, investigators/sites, and IRBs/IECs should assess their current practices in order to identify gaps in support of risk-based project decisions. Proactively at the start of the project and during issues management, risk management should be part of a quality system that supports GCPs for each project’s unique challenges. The GCPs alone do not support essential risk-based decisions per unique needs and outcomes of each protocol for each stakeholder (sponsor, vendor, investigator, and ethics committee).

Practices of minimizing documentation of process management of project issues are “risky” and have resulted in the opposite of their intent to minimize impact of project deficiencies. In some cases, these practices have resulted in poor inspection outcomes. Incorporating risk management principles into all stakeholder quality systems aligns with regulatory authorities’ movement to risk-based inspectional approaches.

This course will present how to incorporate risk management process and strategies to current clinical project management systems for all stakeholders.

VideoPreview

 

Learning Objectives 

  • Define quality system levels and applicable areas of clinical site management
  • Define risk management
  • Apply seven risk management strategies in clinical site management
  • Apply risk management tools to case scenarios

Who Should Attend 

  • Sponsor/CRO Study Teams
  • Investigator/CRC Site Study Teams
  • Ethics Committee Members

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 

2 hours; 12:00 - 2:00 p.m. Eastern

Course Dates 

December 3, 2010                                       

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)