- FINAL GUIDANCE: Electronic Source Data In Clinical Investigations (Procedural)
- Federal Registration FR NOA
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.
Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.
After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided.
Questions/Comments can be submitted live via a Q/A chat window.
Webinar Access link: https://collaboration.fda.gov/guidancewebinars
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
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