CAEndOfTrial object
End of trial declaration mandatory for
All clinical investigations requiring authorisation by CA
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
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
Order of the Minister of Health 2 May 2012 (Dz.U. 2012 poz.491)
