Oncologie (Kanker - Gezwelziekten): Information for sponsors

The oncology research department of the Oncology Centre consists of two units: the Clinical Trials Office Unit (CTO) and the Translational Cancer Research Unit (TCRU). There is an optimal collaboration between these units. Both units have access to an extensive biobank.

CTO continuously aims to improve the quality, the protection and safety of the patients and the reliability of the results. It holds an ISO 9001 quality label since 18 April 2013. The quality team ensures that this label passes every audit.

Each new study proposal must be submitted at registratieloket@gza.be and will be assigned a unique registration number. That registration number must be used in all communication with the CTO unit. The entire feasibility process is monitored through the registration desk. Confidentiality is guaranteed.

As soon as we are in possession of a study protocol and/or synopsis, the proposal is put on the agenda and discussed in the weekly Scientific Policy Committee, and the in-scope and feasibility of the proposal are assessed on the basis of existing criteria. The final advice is sent to you by e-mail. Confidentiality is guaranteed.

Submission to the Scientific Policy Committee  is a prerequisite prior to any other steps to be taken and therefore also necessary for  submission to the GZA Medical Ethics Committee.

Contact details registration desk

• registratieloket@gza.be
• tel. +32 3 443 37 59

Negotiations on the clinical trial agreement (contract), as well as on the financial agreement with all departments involved (with the exception of the pharmacy), are conducted by the financial contractor CTO, in close consultation with the principal investigator.

The registration desk will put you in contact with the financial contractor.

The financial contractor will provide you with the most recent version of the "clinical research general terms and conditions CTO", approved by the GZA legal department. Please either incorporate these in the clinical trial agreement or add them as an appendix to the clinical trial agreement. The use of the pharma.be template is preferred since it has been checked by the legal department and will therefore result in a shorter negotiation period.

Payment overviews for invoicing should be submitted on accountancy.cto@gza.be. This should be done at the end of the second month following the year quarter.

The registration desk will also provide you with the contact details of the hospital pharmacy. After approval by the pharmacy, it is possible to add this agreement as an appendix to the global clinical trial agreement, which must then be co-signed by the pharmacist. But one might  also opt for a separate contract with the pharmacy, in addition to the general clinical trial agreement. In any case, payments for the pharmacy are to be done on a  separate account of CTO ( vide infra).

A new clinical trial can only be started after all parties have signed the clinical trial agreement. Therefore, the clinical trial agreement proposal should be submitted in due time (with sufficient time before submission of the study documents to the Ethics Committee). When all parties have agreed to the clinical trial agreement, a number of copies are first signed by the sponsor/CRO. These are then sent to the financial contractor, who ensures that they are signed by CTO/GZA.

In the event of an amendment to the protocol and/or IC with financial implications, please always send the protocol amendment, the amended IC, the clinical trial amendment proposal and the (planned) date of submission to the Medical Ethics Committee to the financial contractor. Provide all documents in a "track changes" version and/or provide a clear summary of the changes. Preferably, this should be done before (at the latest simultaneously with) the submission to the Ethics Committee.

For this we would like to refer you to the review room of the Medical Ethics Committee.