ECAmendment object

Ethical review mandatory for

Any substantial amendments to research plan

Standard notification form

Standard form to be used is provided in Appendix 3 to Decree No. 841/2010: “Request for opinion on a significant change ot the clinical drug trial”.
NB: Appendices are not available in English!

Timeline Ethical review of SA (max nr days)

35
From date of receipt of valid application

Guidance on submission of SA

Further information is provided in the guidance 'Operating Procedures of the National Committee on Medical Research Ethics (TUKIJA)' in section: 3.5 Amendments to trial protocols.

Applicable national legal framework/ Reference

Section 10d of Act No. 488/1999

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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