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UPCOMING LIVE SEMINARS
 






Monitoring Plan Development

Upcoming Courses
Course #: BI11659
July 15, 2014
1:00 PM - 3:00 PM Eastern
$695.00

Course Description

Although monitoring plans are not defined or specifically required by FDA regulations or the ICH Guideline for Good Clinical Practice, both organizations endorse the use of this tool in a Quality Systems management approach to clinical research. The traditional approach to monitoring plan development has relied upon reinforcing SOP-mandated monitoring activities with little focus on project and/or protocolspecific monitoring needs. This web seminar provides participants with concepts and templates to set up a monitoring plan that supports unique project risks and links to valuable data regarding investigative site and Clinical Research Associate (CRA) performance. Suggestions for development of monitoring plans for a risk-based approach to monitoring are also provided in this session.

Learning Objectives

  • Develop a monitoring plan to meet the unique needs of a project and protocol
  • Identify factors to consider when developing a monitoring plan for a risk-based monitoring approach
  • Link the plan to CRA and site performance to meet project goals and promote continuous improvement

Who Should Attend

  • Clinical Research Associates
  • Project Managers
  • Clinical Research Associate Managers

Instructor

This course will be taught by one of the following instructors:

Linda Carter, R.N., B.S.N.

Nikki Christison, B.S., C.C.R.A.

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 2 hours (0.2 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#: 0778-0000-14-024-L01-P. Released: 4/14.

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. 

Jan - July 2014 Edition

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

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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)