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.

See other languages (French or Dutch)















Last updated on 08/03/2012