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
A standard notification form and cover letter sample are posted on the Ministry’s website.
Timeline for approval of SA (max nr days)
60
From submission of the EC decision
National legal framework in place
Yes
Additional Information
Amendments occurring during conduct of a trial requiring reporting, and those requiring a decision and approval will be determined according to the Guideline for Good Clinical Practice (2014).
It is essential for amendments requiring a decision and approval to be reviewed and concluded by the ethics committee within fifteen days, and by the Agency within sixty days after submission of the ethics committee decision