Source Documentation July 2010

Course Description

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.



Learning Objectives

  • 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)

Who Should Attend

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


Sandra SAM Sather, MS, BSN, CCRA, CCRC

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Course Length Time

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

Course Dates 

July 20, 2010               

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