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Developing and Negotiating Research Site Clinical Study Budgets and Contracts August 2012

Course Description 

Negotiating study contracts and budgets is critical for the future success of the clinical research site. This web seminar provides strategic skills and best practices for contract negotiations and budget development. Learners will also review and practice the art of negotiation.

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Learning Objectives 
  • Prepare for negotiations: Define steps in the negotiation process; integrate strategies for effective negotiating; review success factors and risks in negotiations; discuss ethical considerations
  • Review industry study start-up basic contract content: Discuss state law, institutional vs. sponsor required language; “boilerplate” terms; indemnification; other agreements including data use, confidentiality, HIPAA, master agreements
  • Develop study budget presentations: Based on objective market data; subject vs. visit based
  • Assess protocol feasibility and resource needs: Look for hidden costs; study start-up to final query resolution
  • Go from study protocols to successful study budgets: Plan for protocol amendments and procedure changes; financial checks and balances

Who Should Attend 

  • Research Site Representatives that have some direct and/or indirect responsibility in contract and budget negotiations
  • Site Managers
  • Project Managers
  • Contracts and Budget Department Representatives
  • Clinical Research Coordinators
  • Research Nurses
  • Investigators
  • Sponsor Representatives working with sites on study start-up

Instructor 

Lily Romero, P.A., C.C.R.C.  

Click here for complete trainer biographies 

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

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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.

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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)