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.
Patient facing documents can also be uploaded in this section of CTIS. This only concerns patient facing documents, such as questionnaires and diaries, which are used to record endpoints of the study, as described in the protocol. These can be added as separate documents. The patient facing documents must be submitted in accordance with the language requirements for the protocol. For most Member States this is English (see Annex II to the Q&A CTR) . These documents shall be provided to the participants in a language which they understand. The sponsor is responsible for ensuring the quality of the translation. If the study is only carried out in the Netherlands, the patient facing documents can be submitted in the Dutch language only.
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.