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Preparing Clinical Trial Documents for Europe’s New CTIS: Best Practices for Procedures and Processes

European Clinical Trial Regulation (EU-CTR) 536/2014 is expected to go into application in January 2022 with the go-live of the Clinical Trial Information System (CTIS). It will require all stakeholders to submit clinical trial information through the CTIS electronic platform. With the regulation pending, the need to create regulatory documents with disclosure in mind has never been more important.
Preparing Clinical Trial Documents for Europes new CTIS

Countdown to the New EU Clinical Trial Regulation: What to Expect and How to Prepare

European Clinical Trial Regulation (EU-CTR) 536/2014 is expected to go into effect in January 2022, six months after the European Commission’s notice is published in the Official Journal of the European Union, bringing with it new changes to all phases of interventional clinical trials, and a more cohesive approach to trial applications, assessments and reporting. This is intended to create a more consistent, standardized set of rules to be applicable to interventional clinical trials being run across the EU, with an emphasis on increased clinical trial transparency.
Countdown to the new EU Clinical Trial Regulation

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