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CSR pilot FDA releases first clinical study report in data transparency pilot program trialassure fdaaa section 801 requirements fdaaa trials tracker

FDA Issues its First Action for Non-Compliance with ClinicalTrials.Gov FDAAA Section 801 Requirements

by Staff Writer | April 2021

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health checks on all applications at regular

What Is IT Governance And Why Does It Propel Massive Growth?

by Mohamad Zahreddine | April 2021

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Certara Adopts TrialAssure ANONYMIZE Solution

Certara Adopts TrialAssure ANONYMIZE Solution to Speed Life Science Industry Need to Meet Regulatory Requirements for Data Sharing

by Staff Writer | March 2021

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trialassure data sharing EMA COVID-19 assessments Clinical Trials Information System (CTIS), a new European trial registry due CTIS EU Clinical Trial Regulation

This week in transparency news: February 12-26, 2021

by Staff Writer | February 2021

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Businesses Should Continually Re-Evaluate Application Vendors

Don’t Get Too Comfortable With Your Technology Vendors And Applications

by Mohamad Zahreddine | February 2021

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italy FDA EMA HC PRCI phuse data transparency nhs us uk eu make it public ctis eudract who World Health Assembly Update NIHR policy on registration and disclosure of clinical trial results – National Institute for Health Research NIHR researchers introduced a new policy on clinical trial transparency. The policy aims to improve trial registration and results disclosure to ensure full transparency of clinical trials funded by the NIHR. Additionally, clinical trials—along with all other research studies—must comply with the NIHR’s data sharing requirements. Until recently, clinical trial and medical device submission data was not fully available to the public and restricted to particular researchers in Canada. Now, data about medical devices and drugs are starting to be posted online via Health Canada’s new Clinical Information Portal. The European Medicines Agency will be looking at reviving its policy on proactive publishing of clinical study reports, which is currently suspended as the agency copes with huge staff losses on account of Brexit. Policy 0043 – a policy which gave access to EMA’s archived documents – is now limited to use by European Union citizens only. Additionally, excessive workload is said to be the cause for cutbacks, including the suspensions of publishing new data packages as a part of Policy 0070. The article states that this is a major interruption of the important transparency initiatives that need to be continued. World Health Organization (WHO) website, 12 of the world’s largest medical research funding agencies and international organizations pledged to implement policies within 12 months that mandate the registration and public disclosure of results for all trials they fund, co-fund, sponsor, or support. Among the signatories are the two largest private medical research funders in the world, the Gates Foundation and the Wellcome Trust. The announcement comes on the heels of the NIH Final Rule governing ClinicalTrials.gov disclosures, which went into effect in January, and underlines the commitment toward transparency of the international research community. Referencing the 2013 Declaration of Helsinki, Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure will be bringing a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows: Senator introduces legislation to amends Sunshine Act – Policy & Medicine Senator Claire McCaskill proposed the Patient Advocacy Transparency Act of 2018 this week that widens Open Payment reporting and amends the Physician Payment Sunshine Act

This week in transparency news: January 30 – February 12, 2021

by Staff Writer | February 2021

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This week in transparency news: January 9 – January 29, 2021

by Staff Writer | January 2021

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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: December 19, 2020 – January 8, 2021

by Staff Writer | January 2021

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CSR pilot FDA releases first clinical study report in data transparency pilot program trialassure fdaaa section 801 requirements fdaaa trials tracker

Enforcing Compliance to FDAAA 801 Clinical Trial Registration and Results Disclosure Requirements

by Kasim McLain | January 2021

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trialassure data sharing EMA COVID-19 assessments Clinical Trials Information System (CTIS), a new European trial registry due CTIS EU Clinical Trial Regulation

Whitepaper: Start Plain Language Summaries Early or Get Left Behind

by Staff Writer | December 2020

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