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

by Donald McLean, MBA,
Posted on 1/11/2019

Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:

Whitepaper published giving global transparency view – PhUSE  

Last month, the Data Transparency working group of PhUSE – a global membership organization and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers and eClinical IT professionals – published a whitepaper titled Clinical Trial Transparency and Disclosure; A Global View. The whitepaper is part of their Clinical Trials Toolkit project, discussing mandatory requirements, voluntary activities, World Health Organization (WHO) registries, industry guidance, and the submission lifecycle.

Read the full transparency whitepaper.

How the UK proposes to regulate clinical trials in case of a ‘no-deal’ Brexit: Updated guidance released Outsourcing-Pharma.com

The UK Government last week provided an update on the regulation of clinical trials in the event of a “no deal” Brexit, with a commitment to ensure any new requirements are not “unduly burdensome.”

Read Melissa Fassbender’s summary here.

Phishing: Why we should teach employees to be skepticsForbes.com

TrialAssure CIO Mohamad Zahreddine penned an article for Forbes.com this week discussing phishing attacks, explaining that “If a threat actor successfully phishes an employee, it can provide them access to the company’s entire network of resources throughout the enterprise.” The article goes on to give seven guidelines for how to speak with colleagues and change their behaviors.

Read the full piece on Forbes.com.

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