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          FDA Webinar: Final GFI: Electronic Source Data In Clinical Investigations (Procedural) - January 29, 2014Guidance Webinar Series FDA Webinar: Final GFI: Electronic Source Data In Clinical Investigations (Procedural) - January 29, 2014
  
  	
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    PrintOn January 29, 2014, FDA presented a webinar on a final guidance for industry titled “Electronic Source Data in Clinical Investigations."**FINAL GFI**:  Electronic Source Data In Clinical Investigations (Procedural)http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf**FR NOA**: http://www.gpo.gov/fdsys/pkg/FR-2013-09-18/pdf/2013-22645.pdf**SUMMARY**: The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled “Electronic Source Data in Clinical Investigations.” This final guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.Presentation InformationElectronic Source Data In Clinical InvestigationsFinal Guidance on Electronic Source Data In Clinical InvestigationsResourcesForYouCDER Webinars**SPEAKERS:****Leonard V. Sacks, MD**Associate DirectorOffice of Medical PolicyCenter for Drug Evaluation and ResearchFood and Drug Administration**Ron Fitzmartin, PhD, MBA**Office of Strategic ProgramsCenter for Drug Evaluation and ResearchFood and Drug Administration**Jonathan S. Helfgott, MS**Associate Director for Risk Science (Acting)Office of Scientific InvestigationsCenter for Drug Evaluation and ResearchFood and Drug Administration

                                                                                  Content current as of:
      09/09/2015
              
              
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			  Training & EducationGuidance Webinar Series
 
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