ECSubmissionOfApplication object

Responsible for study submission

Sponsor

Guidance on study submission

The required documentation for EC application is provided in Deliberação n.º 514/2010, de 3 de Março

National Ethics Committee (CEIC) - Same as the one described above for Infarmed, but more details about the documents evaluated by CEIC experts are provided at CEIC Website: http://www.ceic.pt/documentos-submissao
and at RNEC: https://www.rnec.pt/pt/submissao-nacional

Local Ethics Committees have specific Forms to fill-in and the same documents evaluated by CEIC.

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