ECAmendment object
Ethical review mandatory for
Any substantial amendments (concerning investigator, trial site, informed consent)
Responsible for notification of SA
Investigator
Guidance on submission of SA
Circular letter 575 provides guidance on the submission and characterization of amendments to the EC
(available on the FAMPH website in section: Human medicines > Medicines > Herbal medicinal products > Research and Development > Clinical trials)
Additional Information
The investigator must notify the EC concerned on the content and reasons of any substantial amendments planned