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  1. Guidance Webinar Series

FDA Webinar: Final GFI: Electronic Source Data In Clinical Investigations (Procedural) - January 29, 2014

 

On January 29, 2014, FDA presented a webinar on a final guidance for industry titled “Electronic Source Data in Clinical Investigations."
 
   
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 Information

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SPEAKERS:
Leonard V. Sacks, MD
Associate Director
Office of Medical Policy
Center for Drug Evaluation and Research
Food and Drug Administration
 
Ron Fitzmartin, PhD, MBA
Office of Strategic Programs
Center for Drug Evaluation and Research
Food and Drug Administration
 
Jonathan S. Helfgott, MS
Associate Director for Risk Science (Acting)
Office of Scientific Investigations
Center for Drug Evaluation and Research
Food and Drug Administration