Safety & privacy

Patient safety is a priority in clinical research at any time.  This can be guaranteed by following measures:

Every clinical trial should be submitted to the authorities in according to applicable legislation.  In Belgium this is the Federal Agency for Medicines and Health Products, (FAMHP).  The trial can only start after the approval of the authorities .

Also an independent ethics committee reviews the safety and ethical aspects of the study protocol.   Only when the authorities as well as the ethics committee did not report any shortcomings, the trial can be initiated. 

Within CTO the policy committee CTO offers extra guarantees for safety.  First, the clinical trial can only be started after  this committee confirms the study can be conducted in a safe manner.  Secondly, this committee supervises the course of the trial.  It also keeps close contact with the ethics committee of the hospital. 

Researchers (physicians, employees) are working according to the ICH-GCP guidelines and the relevant legislation.

There is a on-call duty system for specialists of the Oncology Centre. The emergency department of the hospital  is available at all times.

A continuous and close follow-up of the study participant is guaranteed by the investigators;

There is a continuous exchange of information between the study sites and a continuous follow-up by and communication with the initiator/sponsor of the study product. 

Privacy

According to the law on privacy of December 8  in 1992, you have the right to  inspect and correct the data collected on you (if applicable).  The hospital has its own privacy statement.  It can be asked for. 

All internal employees in a clinical trial are bound by professional secrecy.  Certain clinical trials also require the signing of an extra confidentiality clause.