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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
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Consortium of Universities fo Global Health (CUGH) offers a bi - weekly feature

Consortium of Universities fo Global Health (CUGH) offers a bi - weekly feature: a case - series from rural Uganda called “Reasoning without Resources”.The target audience is clinicians practicing in low resource settings, medicine and family medicine residents, and senior medical students with an interest in clinical global health.

The series is assumes that medical textboo ks, written for those who can access and afford them, have limited relevance to making a diagnosis in most of the world’s hospitals. This case-series addresses that reality by developing clinical skills as the fundamental "diagnostic test" available to clinicians, and sound clinical reasoning as the clinician’s principle resource. Through its Question and Answer format, the series focuses as much on pedagogical process as on biomedical content. In taking on these broad basic challenges, it hopes to inform medical education and cost-effective medical practice in modern medical settings as well.

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Bookmarked by Liam Boggs on June 21, 2013
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Indian Journal of Medical Ethics

The Indian Journal of Medical Ethics is a platform for discussion on health care ethics, with special reference to the problems of developing countries. Research ethics is frequently covered, with papers potentially of interest for clinical data managers and clinical researchers both in the South and the North.

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Bookmarked by Raffaella Ravinetto on May 8, 2013
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WWARN Toolkit

The WorldWide Antimalarial Resistance Network (WWARN) has developed a Toolkit which contains a growing portfolio of tools and services to promote high-quality antimalarial efficacy and laboratory testing. These include also tools for data collection and analysis.
Even if malaria-specific, the Toolkit may offer precious guidance also to data managers active in other fields.

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Bookmarked by Raffaella Ravinetto on April 25, 2013
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Data sharing policy of National Instittute of Health, USA

In the recent years more talks has been on the sharing of data outside the project and research group. Here is the link of the guidance/policy statement provided by the National Institutes of Health (NIH) on data sharing and additional information on the implementation of this policy.

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Bookmarked by Paritosh Malaviya on March 14, 2013
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