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What must I submit for the official application?

Below you will find a list of the documents (including the number of copies) that you must send to the Gene Therapy Office.

Part A

Documents belonging to Part A of the application form must be sent in singular as hardcopy because of the necessity for the documents to be signed. Confidential information, such as the signed consent form and the general (personal) information must be submitted separately.

In addition, two CD-ROMs must be submitted with the Part A of the application (in both Word and PDF format) and accompanying literature in PDF format. Confidential information, including the signed consent form and the general (personal) information must be submitted as separate files.

The SNIF form must be completed in English and sent to the Gene Therapy Office by email in Word format.

Part B

The ABR form belonging to Part B of the application form must be submitted via the web portal ToetsingOnline, http://www.toetsingonline.nl/. You may include certain data which can be uploaded from the EudraCT form. On the CCMO website you will find an example of the ABR form and explanatory notes.

Once you have a final version of the ABR form you must send in a signed version, together with your research file, on two CD-ROMs in PDF format together with a signed cover letter on paper to the Gene Therapy Office. The CCMO prefers digital submission of your application. It is also possible to send the application in duplicate on paper.

The Ministry of VWS requires digital submission, which means that the cover letter should be on paper but all remaining documents should be submitted in PDF format on a single CD-ROM, coded according to the standard research file (more information is available at http://www.ccmo.nl/, ´standard research file´).

Official submission application

Diagram document flow for official submission to the Gene Therapy Office

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