CAEndOfTrial object
End of trial declaration mandatory for
All clinical trials requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Regular Termination - Declaration timespan (max nr days)
90
Timespan counted from
Last patient - last visit in the respective country
Early/premature Termination - Declaration timespan (max nr days)
15
Reasons for early termination shall be clearly stated
Yes
Standard Declaration form available
Yes
Standard Declaration form
European "Declaration of the End of Trial Form" (Formulário de declaração de fim de EC):
to be used for declaration to the CA and the EC, provided on the INFARMED website in section Medicamentos Uso Humano> Ensaios Clinicos> Formulários
Guidance on End of trial declaration
Declaration of the End of Trial Form (cf. Section 4.2.1 of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial CT-1)
