New Subject Information Sheet (SIS) template now available on the CCMO website
A new template (in Dutch) for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on the CCMO website. With this model investigators can draw up the information letter for adult test subjects
In addition to corrections of some ambiguities, adjustments have been made that were necessary due to changed and adapted legislation and regulations, such as the European Medicines Regulation (CTR) and amendments to the WMO and the Insurance Decree. Researchers are requested to use the new model with immediate effect.
An updated English translation of the template is at your disposal, but can be used for information purposes only. As before, a Dutch version has to be submitted to the review committee.