‘Quick Guide’ To Help EU Clinical Trial Sponsors As CTIS Hits 31 January Milestone
Just a day before it became mandatory to use the single-portal Clinical Trial Information System, the European Commission published concise advice for sponsors and investigators who want to conduct trials in Europe.
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Sponsors Under Fire For Excessive Data Redactions & Deferrals In EU Clinical Trials Portal
An analysis of publicly available information in the EU Clinical Trials Information System shows how commercial and academic sponsors differ in their approach to transparency. There are also concerns around the lack of “push back” from EU member states to address potential non-compliance.
EU Issues More Q&As To Support Compliance With Clinical Trials Regulation
The European Commission has come up with a workaround to address a current lack of functionality in the Clinical Trial Information System, while the European Medicines Agency has addressed technical queries on CTIS and the Clinical Trials Regulation.
EMA Confirms CTIS Ready For Mandatory Use By 31 January Deadline
The European Medicines Agency says that over 80% of the blocking issues and related workarounds affecting the Clinical Trials Information System have been resolved.