When requesting a preliminary meeting, the investigator is expected to submit (electronically) to the Gene Therapy Office as many documents as possible (e.g. application form, research protocol, investigator’s brochure, IMPD (Investigational Medicinal Product Dossier)) that relate to the application so that these can be examined by the various bodies.
The following items belonging to the draft application must always be submitted:
- Part A of the draft application, for the GMO (Genetically Modified Organism) Office and COGEM (Netherlands Commission on Genetic Modification), should be almost completely filled in. This means that the parts ‘A2 - Biosafety details’ and ‘A4 - Risk analysis information’ must always be filled in. The legal entity (parts A 1.5 and A 1.9) and responsible employee must already be known. The remaining parts should preferably also be complete, with the exception of ‘Part A, Appendix 2: General information (confidential part)’ which does not need to be filled in. Details relating to the production of the GMO are also not required.
- Part B of the draft application and the corresponding file for the CCMO (Central Committee on Research involving Human Subjects) must be present in a draft version that includes a clear idea of the study design as well as relevant information about the product.
If the investigator has specific questions, these can be submitted in writing, either beforehand or following the aforementioned meeting with the bodies involved. This means that the preliminary meeting can be used to discuss more complex questions or any ambiguities that still exist in the eyes of the various bodies.
At least 2 weeks prior to the preliminary meeting, the investigator must provide the Gene Therapy Office with the first name, surname and institution name of all participants who will attend on behalf of the applicant. The responsible employee and the environmental safety officer (ESO) must always be present at the preliminary meeting. The presence of the relevant hospital pharmacist is also advisable.
During the preliminary meeting the investigator is expected to give a short presentation about the research.