ECAmendment object
Ethical review mandatory for
Any substantial amendments
Responsible for notification of SA
Sponsor
Standard notification form available
Yes
Standard notification form
Standard Form for Submission of Amendments ("Wzór wniosku o wydanie pozwolenia na wprowadzenie zmian w badaniu klinicznym") to CA and EC is provided on the URPL website.
The application form is also provided in Annex 2 (Załącznik Nr.2) of Health Minister Order 15 Nov 2010.
Timeline Ethical review of SA (max nr days)
60
Additional Information
NB! A positive opinion of the competent EC is a prerequisite for application to the CA.