Several notifications and reports must be submitted to the Minister of IenW Ministry of Infrastructure and Water Management (Ministry of Infrastructure and Water Management ) through the Gene Therapy Office.
Report on proposed work (BVW description of the proposed work (description of the proposed work ))
Before starting any work on the study, the investigator (permit holder) is obliged to send a description of the proposed work (BVW) by registered post to the Ministry of IenW care of the Gene Therapy Office. Work cannot start until at least 15 days after the BVW has been sent, or as soon as receipt of the BVW has been confirmed in writing. A template for the BVW is included with the permit and should include the following:
- Start date of work
- Exact location of the work
- Short description of the study content
- The number of research subjects that will be included
- The total number of research subjects enrolled in the study.
Progress report (VVW progress report on the work (progress report on the work ))
Every year, before March 1st, the permit holder is required to send a progress report on the work (VVW) of the previous calender year. The report must include:
- The number of research subjects that have been included in the study
- The total number of research subjects to be included in the study
- The results of research that relate to the safety measures referred to in the permit
- Notifications of unforeseen circumstances. Reference must be made to any previous notification of these circumstances in a different context.
After completion of the work and before the end of the calendar year, the investigator (permit holder) is obliged to submit a final report presenting the results of the work that is covered by the IenW permit. The final report is focused on gene therapy studies and is based on the report format established by Decision 2003/701/EG of the Commission of the European Communities of 29 September 2003 (PbEU L254).
The final report must be completed in English and sent in to the GMO Genetically Modified Organism (Genetically Modified Organism ) Office through the Gene Therapy Office as an electronic file in MS Word format.