Belgium Clinical Trial Agreement Template

Prior to the start of the experiment, the clinical trial sponsor must have an insurance policy covering his or her liability and that of those involved in the experiment, regardless of the link between the stakeholder, the clinical trial sponsor and the participants. The time to review the contract can be accelerated 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 continuing the audit are available on the website of the Ethics Commission of Hospital Faculty at the following address: procedure for submitting a new clinical research project When dispensing drugs for compassionate use, please send an agreement to the central commercial counter. The sponsor of the clinical trial must maintain a detailed record of all adverse events reported by investigators. These registers must be forwarded to the Minister upon request if the experiment is conducted in Belgium (Article 27). The investigator is required to immediately report to the clinical trial sponsor any serious adverse events, with the exception of serious adverse events for which the investigator`s minutes or brochure do not require immediate notification.

In the event of a reported death, the investigator must provide all additional information requested from the clinical trial sponsor and the approved ethics committee. Clinical trials can only begin if they have been found to be positive by the Ethics Committee and if the Federal Agency for Medicines and Health Products has not found a major deficiency in the legal time frame provided by the Human Experimentation Act (7 May 2004). An application must be submitted to the Agency and accompanied by the payment of a fee. 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.