All documentation required by your Ethics Committee or R&D Department is available here. You may download these documents as required and do contact us if you need any further information.
If any changes are required by your Ethical Committee to our study documentation we will require a copy of this (in English) for our files. This includes the trial Protocol, Patient Information and Consent leaflet and all follow-up forms.
Please also ensure you check and amend your version numbers as appropriate.
If you are from Belgium, Germany, Italy, Serbia or Sweden you will also need EQ-5D (Quality of Life Questionnaire) approval from your Ethics Committee. The EQ-5D forms are sent to your centre's patients once a year with the Annual Follow Up forms. Please download the EQ-5D forms here:
If you require an accompanying letter for ethics submission, please request that from us here.