CCMO has developed a clinical trial protocol template along with explanatory notes. This protocol template has been designed for clinical trials with a medicinal product that are subject to the CTR. Please note that the use of the template is not obligatory.
Please check the CCMO website regularly for the most recent version.
The protocol should contain a summary in English and Dutch. It is recommended to have the Dutch synopsis in lay language. The synopsis 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 patient-facing documents are used in the trial to measure primary or secondary endpoints, as described in the protocol, then these documents should be submitted in CTIS. This concerns documents given to participants, such as questionnaires or diaries. These should be uploaded as separate documents in the Protocol section (document code D4), in the same language as the Protocol itself, which is usually English. For mononational trials only in the Netherlands, it is allowed to submit a Dutch version instead of an English version.
Please note: many Member States require that translations of these patient-facing documents in their national language(s) are submitted in Part II (section 'Compliance with national requirements on data protection', document code R2), but this does not apply for the Netherlands. The requirements of other Member States are shown in Annex II of the CTR Q&A of the European Commission.
If a Data Safety Monitoring Board (DSMB) is established, the Charter DSMB should be submitted as well.
See also the Instruction on uploading, naming and changing documents for the correct naming of the various documents that can be submitted in this section.