USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework
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EU – Version 5 of the Questions and Answers Document for the EU Clinical Trials Regulation (Regulation EU/536/2014) has Been Published
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AUSTRALIA – TGA Consultation on Whether or Not Certain International Scientific Guidelines Should be Adopted
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AUSTRALIA – TGA Consultation: Improving access to medicine adverse event data – sponsor survey
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USA | Draft FDA Guidance on the Correct Definition of a ‘Device’
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UK | New IRAS Guidance for Interventional Research
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NORWAY | Lessons Leaned – Data Privacy and Research Ethics
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USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices
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Global – Revision 1 of ICH E8 (Clinical Studies) Published
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