The new Clinical Trial Regulation (CTR) is set to revolutionize clinical trial processes throughout Europe, affecting all European Union (EU) member states and organizations headquartered in other countries wishing to conduct clinical trials on Investigational Medicinal Products (IMPs) in the area. Clinical Trials Information System (CTIS), a centralized portal/application, will be used to standardize… Continue reading Clinical Trial Regulation (CTR) Will Transform Clinical Trial Processes
Upcoming Layperson/Plain Language Summary (PLS) Regulations The much-anticipated 2014 European Union Clinical Trial Regulation 536 (EU CTR) requiring the sponsors and academic researchers conducting research trials to draft layperson/plain language summaries (PLS) is set to go into effect in 2023. The regulation will most likely flow to other countries and will be adopted by various… Continue reading Upcoming Layperson/Plain Language Summary (PLS) Regulations
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