If you are providing medication for compassionate purposes, please send an agreement to the central trade counter. In line with its strong position in clinical research, Belgium was one of the first European Member States where the Regulation on the Application of the Clinical Trials Directive is fully operational. The specific conditions provided by the human experimentation legislation reinforce Belgium as a very attractive host for clinical trials and guarantee a sustainable environment for innovative research. Pharma.be, the Belgian pharmaceutical industry association, wants to play its part in research in Belgium by specifying the practical implications of the new regulations. This new edition of operational guidance not only analyses Belgian law from the point of view of the promoter of a clinical trial, but also deals with the roles and tasks of all those involved in clinical trials. In order to support all clinical trial participants, the guide provides an overview and overview of the submission and evaluation processes by the competent authority and the ethics committee of a clinical study application. In addition, standard templates for the most important documents are added to a Rom CD. This book is extremely useful, both for study sponsors and for all other players in medical research and development, such as members of ethics committees, doctors, pharmacists, administrators, etc. The first edition of clinical trials in Belgium was quickly described as a standard manual on the new EU regulatory framework and its transposition into Belgian legislation. In the case of CTR pilot studies, please follow the clinical research contract management procedure by adding the following documents: the OEB`s reporting document, study protocol, information form, insurance certificate and conflict of interest disclosure form, which has been completed and signed by the Clinics Senior Auditor.
Procedure for submitting a new clinical research project Clinical research contract submission procedure (for commercial sponsor sponsors): contract review time may be expedited if a validated proposal is proposed. The central window only deals with the first contributions to studies. The amendments and amendments are managed by the research team and forwarded directly to the ethics committee. It also assumes responsibility for the ongoing review of clinical research: annual reports for intervention studies, DSUR for drug studies as well as SUSARs, deviations, injuries, unexpected events, CAS with life, end of study notifications. Documents relating to the clinical research that is continuing the review are available on the website of the Ethics Commission of Hospital Faculty at: www.saintluc.be/en/research/ethics-committee-continuing-review.php .