New Subject Information Sheet for adults now available

A new template for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on the CCMO website. This template allows researchers to prepare the information sheet for adult subjects.

The template has been rewritten and the language has been made more accessible. Investigators are invited to use the new model as soon as possible, but in any case from 1 November 2020. From then on, the new model will be used in the Netherlands as a yardstick in the assessment by the review committee.

In cooperation with the Dutch Clinical Research Foundation (DCRF), with emphatic input from patients, the Dutch template has been rewritten at language level B1. This has made the information more readable and understandable. The central government uses language level B1 for texts on its websites, among other things.

An English translation of the template is at your disposal, but can be used for information purposes only. A Dutch version has to be submitted to the review committee.