ECEndOfTrial object
End of trial Declaration mandatory
Yes
Responsible for End of trial Declaration
Sponsor
Regular Termination - Declaration timespan (max nr days)
90
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
Standard declaration form is provided in Annex 3 of the Minister of Health (Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491).
Guidance on End of trial declaration available
Yes
Guidance on End of trial declaration
The process for end of trial declaration is described in detail in a regulation issued by the Minister of Health (Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491).
Applicable national legal framework/ Reference
Art 37ab, 1-2, Pharmaceutical Law 2001/ Dz.U. 2008 nr 45 poz. 271 (pl)
Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491)
