Below, the application forms can be downloaded for clinical research using genetically modified bacteria.
Application form, Part A
Documents belonging to the application form, Part A, must be submitted as single hardcopies, as they need to be signed. Confidential documents, such as the signed consent form and the part containing the general (personal) information, must be submitted at the same time but as separate documents.
In addition, two (2) CD-ROMs must be submitted, containing the application form, Part A (both in Word and PDF format) and the corresponding literature (in PDF format). Confidential information, including the signed consent form and the part containing the general (personal) information, must be submitted as separate files. More information about what you need to submit.
Application form, Part B
The ABR formGeneral Assessment and Registration form belonging to the application form, Part B, must be filled out online, at the web portal http://www.toetsingonline.nl/. When filling out this form online, certain data can be uploaded from the EudraCTEuropean Union Drug Regulating Authorities Clinical Trials form. On the CCMOCentral Committee on Research involving Human Subjects website you will find an example of an ABR form as well as an explanation of the questions asked.
After completing the ABR form, you are required to submit a signed version, together with your research dossier, on two (2) CD-ROMs, in PDF format, together with the cover letter in hardcopy, to the Gene Therapy Office. At the CCMO, your application should preferably be submitted in digital form, but alternatively may be presented in duplicate on paper.
Digital submission is mandatory at the Ministry of Health, Welfare and Sport (VWSMinistry of Health, Welfare and Sport ). This means that the cover letter is presented on paper and that all other documents are submitted in PDF format on one (1) CD ROM, coded according to the standard research dossier (for more information, see http://www.ccmo.nl/, ‘standard research dossier’). More information about what you need to submit.
SNIFSummary Notification Information Format B Form
The SNIF form must be filled out in English and submitted as a Word document by email to the Gene Therapy Office.