Lack of adequate and/or accurate source documentation has been noted as a common deficiency in inspection findings of clinical investigators. There is significant variability between stakeholder requirements regarding source documentation per study, including sponsor to sponsor, sponsor to site, etc. The creation and use of source document worksheets and the use of the CRF as the original source have raised a lot of industry debate. These issues and more regarding adequate and accurate source documentation to meet the requirements of regulatory agencies essential documentation standards will be presented and discussed.
- Define source documents
- Identify regulatory authorities required characteristics of source data
- Analyze source document worksheets: the love-hate relationship
- Discuss the CRF as source data
- Evaluate best practices (group activity)
- Site Research Directors/Managers
- Clinical Research Coordinators
- Principal Investigators
- Project Managers/CRA Managers
Sandra SAM Sather, MS, BSN, CCRA, CCRC
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2 hours; 12:00 - 2:00 p.m. Eastern
July 20, 2010
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For more information, contact Naila Ganatra at (215) 413-2471