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
Guidance on submission of SA available
Yes
Guidance on submission of SA
A comprehensive guideline providing detailed guidance on format, content and required appendixes of application as well as on the trial conduct (notification on amendments, trial termination etc.) is available (Guidance on The Format of Applications for Clinical Trials to Ethics Committee 2014).
Additional Information
Amendments requiring a decision and approval are determined according to the 'Guideline for Good Clinical Practice (2013)'.
