Transparent Thinking Blog

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This week in transparency news: June 29 – July 12, 2019

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Philippine Health Research Registry (PHRR) trialassure

REGISTRY SNAPSHOT: Philippine Health Research Registry (PHRR)

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German Clinical Trials Register (DRKS) trialassure

REGISTRY SNAPSHOT: German Clinical Trials Register (DRKS)

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This week in transparency news: June 22 – June 28, 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The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of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 Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking.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

How TrialAssure Gathers Client Feedback to Build Stronger Clinical Trial Transparency Software

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Peruvian Clinical Trials Registry (REPEC) peru trialassure

REGISTRY SNAPSHOT: The Peruvian Clinical Trials Registry (REPEC)

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Policy 0070 submissions pending suspension in Europe – DIA Communities Due to EMA’s relocation from London to Amsterdam, the “launch of new procedures (related to clinical data publication under Policy 0070) will be temporarily suspended already as of 1 August 2018,” according to an email shared by Melanie Carr, Head of Stakeholders and Communication Division and Head of Corporate Stakeholders Department ad interim, European Medicines Agency (EMA). It is noted that all redaction proposal packages submitted after July 31st will be temporarily suspended. A press release with full details is said to be released next week.

This week in transparency news: June 15 – June 21, 2019

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Pan African Clinical Trials Registry (PACTR) south africa trialassure

REGISTRY SNAPSHOT: Pan African Clinical Trials Registry (PACTR)

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The U.S. Senate had voted in favor of an opioid bill that expands Open Payments to include payments made to Nurse Practitioners, Physician Assistants, Nurse Midwifes, Nurse Anesthetists, and Clinical Nurse Specialists, in addition to current physician reporting requirements. This will go into effect beginning January 1, 2022. Inconsistent Clinical Trial Disclosure and Lack of Compliance Across Big Pharma

This week in transparency news: June 8 – June 14, 2019

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TrialAssure launches TrialResults.com for Clinical Trial Sponsors to Publicly Post Plain Language Summaries

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