Sections Form and MSC
The sections Form and MSC must be completed for every initial application.
Form
Initial application details
- Cover letter: placeholder to upload cover letter;
- Proof of payment of fee: in the Netherlands, the fee is paid after submission. Therefore, instead of a proof of payment, a form with invoice details is uploaded here;
- Compliance with Regulation (EU) 2016/679: placeholder to upload statement;
- Trial category: indicate whether category 1, 2 or 3 applies to the clinical trial, including a short justification. This category determines which documents and data will be published, and when.
MSC
- Overview of the member states concerned including the proposed reporting member state. Also an overview of the participating countries outside the European Economic Area.