ECAmendment object

Ethical review mandatory for

Any substantial amendments

Responsible for notification of SA

Sponsor

Standard notification form available

Yes

Standard notification form

A standard notification form and cover letter sample are posted on the Ministry’s website.

Timeline Ethical review of SA (max nr days)

15

Applicable national legal framework/ Reference

Regulation On Medical Device Clinical Trials 2014

Additional Information

Amendments occurring during conduct of a trial requiring reporting, and those requiring a decision and approval will be determined according to the Guideline for Good Clinical Practice (2014).
Amendments requiring a decision and approval to be reviewed and concluded by the ethics committee within fifteen days, and by the Agency within sixty days after submission of the ethics committee decision.

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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