ECAmendment object

Ethical review mandatory for

Any substantial amendments

Responsible for notification of SA

Sponsor

Standard notification form available

Yes

Standard notification form

EudraCT Notification of Amendment Form (B5)
NB: mandatory to be used

Timeline Ethical review of SA (max nr days)

35

Guidance on submission of SA

The templates for the forms and cover letter and related information is provided on the CCMO website in section Home>Investigators>During and after the research >Changes to the research file (amendments)

National legal framework in place

Yes

Applicable national legal framework/ Reference

Section 13(k) WMO (en)

Additional Information

Submission format:
The signed cover letter must be in hard copy for the submission of substantial amendments to the reviewing committees (MRECs and the CCMO).
All other documents which are part of a substantial amendment, are to be sent on cd-rom (together with the hard copy cover letter)

Supplementary information is provided in the European CT-1-Guidance document: ‘Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial’

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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