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.

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Associate Director

Office of Medical Policy

Center for Drug Evaluation and Research

Food and Drug Administration

 

Office of Strategic Programs

Center for Drug Evaluation and Research

Food and Drug Administration

 

Associate Director for Risk Science (Acting)

Office of Scientific Investigations

Center for Drug Evaluation and Research

Food and Drug Administration