Protocol

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.

This is the first version (version 1.0, May 2022) of the Clinical Trial Protocol template developed by the CCMO. This version is at the moment open for consultation by the drug METCs and the DCRF, but is now already been made available to support non-commercial sponsors. Please regularly check the CCMO website for possible updated versions.

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. Exceptions are validated standard questionnaires, for example the SF36, which do not need to be submitted for review. Preference is given to the submission of patient facing documents in the Dutch language, but if these are not yet present at the time of the application, they can be submitted in English.

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.