ECEndOfTrial object
End of trial Declaration mandatory
No
Additional Information
No explicit declaration obligations to ECs are legally fixed in the Swedish Acts (GCP is regulated in the Drug Act, but mostly referred to and not incorporated; GCP not a part of the Act regulating the ECs, however it is also here referred to).
So in practice, very few reports are submitted to ECs, e.g., in the case of:
the sponsor is a company, the declaration and final report are sent to ECs because the company SOPs ask for it.
a new application, if this is a continuing work, based on a previously approved study.
There is no offense in no shipping reports to ECs, taking for granted that they have been shipped to the CA.
