Articles

New England Journal of Medicine Reacts to CMS Data Release

The New England Journal of Medicine has two perspective pieces on the recent public data release by the Centers for Medicare and Medicaid Services (CMS). The first provides the reasoning and context from the perspective...

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FDA Releases Guidance on GUDID

The FDA has just released the finalized version of it’s “Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff.” The document outlines the process of submitting data to...

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Risks and responsibilities: data management and information security

My article on data management and information security issues is being published by the Association of Commonwealth Universities in their Research Global, Volume 33. You can read it here in pre-print. RG Issue 33 March 2013 pp 6-8

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‘Non-parent’ has standing under paternity statement

Although appellant did not prove he is the biological father of a child, the mother is bound by her agreement acknowledging appellant’s paternity and describing him as the child’s natural father, for all intents...

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16 October 2012 PC2-Z Second Annual Symposium: Translating Genomic Medicine through Provider Education

The US Air Force (USAF) Patient-Centered Precision Care Genomic Medicine Research Program (PC2-Z) sponsored by the Air Force Medical Support Agency (AFMSA), and the Uniformed Services University of the Health Sciences (USUHS) hosted a...

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An ethics debate over embryos on the cheap

In the cutthroat field of fertility treatments, Dr. Ernest Zeringue sharply cuts costs by creating a single batch of embryos, then divvying it up among several patients. One ‘horrified’ critic calls it the ‘commodification...

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Women As Senior Research Administration Managers

Women as Senior Research Administration Managers

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Bias, Power, Influence, and Competence: The Implications of Human Nature on the New NIH Conflicts of Interest Regulations

slocum VOE JRA Vol 43 No 1 (2)

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FDA Form 1572

Here’s FDA Form 1572 with instructions Form FDA 1572 – Word (doc) Form FDA 1572 – Word Instructions (doc) Form FDA 1572 – Word Instructions (docx)

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