Principal Investigators (PIs) are required to provide adequate oversight of all clinical research activities at the site, whether the activity is conducted by the PI, by study team members, or by applicable third parties. Adequate oversight encompasses many activities and obligations, such as ensuring regulatory compliance, staff training, and subject medical care. In this web seminar, we will discuss the regulatory requirements and guidance regarding adequate investigator oversight and appropriate delegation of study tasks, review documentation requirements, and determine strategies for appropriate delegation of tasks.
- Recognize the industry concerns about adequate delegation and improper delegation of study activities
- Identify documentation requirements for proper delegation and investigator oversight
- Identify strategies for determining role assignment specific to a study project and requirements of PI oversight
- Site Research Managers
- Investigators
- Clinical Research Associates/Monitors
- Study/CRA Managers
- Clinical Research Coordinators
- Sponsors/CROs
Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
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1.5 hours; 9:00 – 10:30 a.m. Eastern
September 27, 2011
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.