Within one year after the clinical phase of the study is completed, a final report should be submitted (both digitally and on paper for the study file).
The submission procedure of final study reports does not require completion of any BEBO specific forms.
Besides the text of the complete final report an excerpt should be provided, for discussion in the chamber that reviewed the initial dossier at the time. This digital excerpt (not more than 20 pages) should at least contain the following information:
- an overview of the study design,
- description of possible (S)AE’s and SUSAR’s,
- discussion and conclusions.
After the discussion in the MREC the submitting party will receive a written confirmation that the dossier can be considered closed.
For more information you may contact the official secretariat.