CAAmendment object

Authorisation mandatory for

All clinical investigations requiring authorisation by CA

Responsible for submission of SA

Sponsor

Standard notification form available

Yes

Standard notification form

EudraCT Notification of Amendment Form (B5) + cover letter (A1)
(Mandatory to use!)

Timeline for approval of SA (max nr days)

35

Guidance on submission of SA available

Yes

Guidance on submission of SA

Further information and templates for the mandatory notification form to be used (EudraCT Notification of Amendment Form (B5)) and the cover letter (A1) are provided on the CCMO website in section Home>Investigators>Research with a medicinal product & extra review competent authority >During and after the research & the competent authority

Additional Information

Submission format: by email (max 8 MB) or by cd-rom
Timespan of approval counted from receipt of complete submission. NB: no confirmation of receipt is sent by CA!
If the CA has no objections, a ‘No grounds for non-acceptance’ is issued per e-mail. The e-mail is sent to the registered user for the file concerned in ToetsingOnline.

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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