ECAmendment object
Ethical review mandatory for
Any substantial amendments
Responsible for notification of SA
Sponsor
Manufacturer acting as sponsor
Timeline Ethical review of SA (max nr days)
35
Additional Information
Submission format:
The signed cover letter must be in hard copy for the submission of substantial amendments to the METC
All other documents which are part of a substantial amendment, are to be sent on cd-rom (together with the hard copy cover letter)
