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.
- 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
- Site Research Directors/Managers
- Clinical Research Coordinators
- Principal Investigators
- Sponsor Project Managers
Jackie Earabino, R.N., B.S.N.
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2 hours; 12:00 - 2:00 p.m. Eastern
February 23, 2011