Draft circular on the reporting of adverse events observed in clinical trials and submission of annual safety reports: invitation to comment!

A new version of the document "detailed guidance on the collection, verification and presentation of adverse event / reaction reports arising from clinical trials on medicinal products for human use (" CT-3 ') " was published on June 11th 2011. A draft circular giving instructions arising from the transposition of these indications in Belgium is subject to comments of the relevant stakeholders.

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