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Tag: Disclosure of Clinical Trial Results

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Should people share their DNA for drug development purposes? – USA Today Many people don’t realize that sharing a DNA sample with Ancestry.com, 23andMe and others can result in their data being shared. However, this week, the companies pledged that they would disclose when data is shared with corporations or the government. With a $300 million investment by GSK in 23andMe, they state that approximately 80 percent of customers have agreed to share their DNA data. This data is being de-identified before it is shared.

This week in transparency news: May 18 – May 24, 2019

by Staff Writer | May 2019

Posted in Blog
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This week in transparency news: April 13 – April 19, 2019

by Staff Writer | April 2019

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Iranian Registry of Clinical Trials (IRCT) iran trialassure

REGISTRY SNAPSHOT: Iranian Registry of Clinical Trials (IRCT)

by Staff Writer | April 2019

Posted in Snapshots
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This week in transparency news: January 26 – February 1, 2019

by Staff Writer | February 2019

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This week in transparency news: January 19-25, 2019

by Staff Writer | January 2019

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This week in transparency news: January 5-11, 2019

by Staff Writer | January 2019

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This week in transparency news: December 22, 2018 – January 4, 2019

by Staff Writer | January 2019

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The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of previous noncompliance, and/or submitting misleading or false information to ClinicalTrials.gov. While the FDA has not previously begun issuing fines to pharmaceutical companies, this guidance brings that reality one step closer. Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking. Zach Weingarden, Product Solutions Manager, TrialAssure

Common clinical trial transparency questions, answered!

by Staff Writer | November 2018

Posted in Blog
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National Institute of Mental Health (NIMH) trialassure

Clinical Trial Disclosure: More “FDA” Needed in Past and Present Acts

by Staff Writer | November 2012

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