The protocol should specify the information as listed in section D of annex 1 of the CTR.

A template protocol for non-commercial sponsors is in development.

The protocol should contain a lay summary in English and Dutch. This can be part of the protocol or a separate document. A template (ENG and NL) is available. See also question 5.8 of the Q&A CTR.

If a Data Safety Monitoring Board (DSMB) is established, the Charter DSMB should be submitted as well.