CAAmendment object
All clinical investigations requiring authorisation by CA
Sponsor
Yes
EudraCT Notification of Amendment Form (B5) + cover letter (A1)
(Mandatory to use!)
35
Yes
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
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.