Ethics Documentation

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.

1. Original Ethical Approval Document, October 2005
2. Latest Ethical Approval Letter (AM04), December 2007
3. Original REC Application Document, September 2005
4. Oxford Sponsorship Document
5. GP Letter v2, September 2011
6. Amendment No.1 Approval Letter
7. Amendment No.2 Approval Letter
8. Amendment No.3 Approval Letter
9. Amendment No.4 Approval Letter
10. Amendment No.5 Approval Letter
11. Amendment No.6 Approval Letter
12. Amendment No.7 Approval Letter
13. Amendment No.8 Approval Letter
14. Amendment No.9 Approval Letter
15. Amendment No.10 Approval Letter
16. ACST-2 Protocol v4.2, December 2007
17. Patient Information Leaflets
18. Trial Insurance Document

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.

EQ-5D

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:

Belgium (Flemish or French)

Germany

Italy

Serbia

Sweden

If you require an accompanying letter for ethics submission, please request that from us here.