Electronic Source Documentation: Navigating the New FDA Draft Guidance September 2011

Course Description

As the use of electronic source documentation (eSource) increases in clinical research, so does the scrutiny for ensuring the integrity of the systems used to generate and retain electronic source data. In late 2010, new draft guidance was released regarding the use of electronic source documentation, providing direction to sponsors, Contract Research Organizations (CROs), data management centers, and Clinical Investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. The new draft guidance focuses on the flow of data through those systems from input to analysis and “is intended to promote the capture of source data in electronic form.” This web seminar will review how the requirements for paper source documentation translate to the electronic source document as well as examine real-world examples of the FDA’s review of eSource.


Learning Objectives

  • Navigate initiatives in the current regulatory climate leading to the new eSource guidance
  • Examine the three tiers of data management – Data Entry, Data Review, and Data Processing and Transmission
  • Discuss the Clinical Investigator’s responsibilities for eSource data origination, integrity, review, release for processing and retention
  • Assess the implications of the guidance on current source documentation practices and policy
  • Review the FDA’s expectations and inspection processes for eSource

Who Should Attend

  • Clinical Research Associates
  • Project and CRA Managers
  • Clinical Investigators and Staff
  • Clinical Research Professionals involved in site and IRB assessment and/or selection
  • Professionals from Academia involved in the oversight, documentation, and conduct of clinical research
  • Quality Assurance and Compliance Professionals
  • Data Management Professionals


Elizabeth Ronk Nelson, M.P.H. 

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Course Length Time

2 hours; 12:30 - 2:30 p.m. Eastern

Course Dates

October 28, 2011

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