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Clinical Research Site Quality Improvement Strategies: Developing Proactive Project Study Plans February 2011

Feb 23, 2011
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Course Description 

Research sites’ performance conducting clinical trials can be improved through formalized proactive planning and management. Research sponsors commonly develop a monitoring plan for each study protocol to address the unique needs of each project to promote monitoring excellence and flexibility for protocol changes. Research sites can develop a similar plan to support departmental policies and practices to meet the demands and differences between sponsor/CRO projects. This course will present a PCP: Proactive Compliance Plan template and content for research sites’ use to promote high performance management of multiple research studies to meet sponsor and regulatory requirements.

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Learning Objectives 

  • Examine challenges of meeting the compliance expectations of sponsors/CROs and regulatory authorities
  • Promote performance improvement
  • Design successful clinical trial site project plans: borrowing from the traditional monitoring plan, project feasibility assessments, and best practices
  • Implement proactive and effective reactive project management

Who Should Attend 

  • Site Research Directors/Managers
  • Clinical Research Coordinators
  • Principal Investigators
  • CRAs
  • Sponsor Project Managers

Instructor 

Jackie Earabino, R.N., B.S.N.

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Course Length Time 

2 hours; 12:00 - 2:00 p.m. Eastern

Course Dates 

February 23, 2011

Registration Fees