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FDA Webinar: Final : Electronic Source Data In Clinical Investigations (Procedural) - 29-01-2014


On January 29, 2014, from 2:00PM - 3:00PM EST, FDA will present a webinar on a final guidance for industry titled “Electronic Source Data in Clinical Investigations."

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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Bookmarked by Harry van Loen on Jan. 23, 2014

Blog posts

GHN_Editors

Using OpenClinica in “offline mode”

By GHN_Editors

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3rd April 2013 • comment

Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.

20th February 2013 • comment

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25th January 2013 • comment

This article explains the process of data management operations within clinical trials from start to finish.

17th January 2012 • comment

An example of a academic research centre resolving the issue of clinical trial data management Peer reviewed by members of the data management expert committee for this programme.

6th October 2010 • comment