The European Union has updated a question-and-answer document on the Clinical Trials Regulation, adding a new query about intermediate data analysis and revising several existing sections.
In answer to the new question, the Clinical Trials Coordination and Advisory Group explains that sponsors should submit a summary of intermediate data within one year of performing the analysis. There are exceptions. Sponsors do not need to submit summaries when they or the investigators are blinded to the data, when the protocol has clear criteria for continuing the trial, and when there are justified reasons.
The coordination group also updated the document considering the revised Clinical Trials Information System transparency rules and provided new information on changing the principal investigator and on pediatric trial results.
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