Trial documents
Below are the downloadable documents for the EVRA trial. Please click on the appropriate link for information.
Current Ethics Approved Documents:
- EVRA Protocol 6th April 2017
- Protocol Summary Version 2.0 6th January 2014 (pdf)
- Patient Information Sheet Version 2.0 6th January 2014 (word)
- GP Letter V1.0_20130619(word)
- QoL Patient Letter V1.0_20130814 (word)
- EVRA Patient Invite Letter Version 1.0 6th January 2014 (word)
- EVRA Patient Diary Version 1.2 30th January 2014 (word)
- Ulcer Healing patient wallet cards Version 1.0 6th January 2014 (word)
Paper CRF Forms:
- CRFs Version 10th December 2013 (pdf)
- CRF Baseline Visit (pdf)
- CRF Telephone Contact Form (pdf)
- CRF Treatment Visit (pdf)
- CRF Monthly Telephone follow-up (pdf)
- CRF Monthly Telephone follow-up - 6/12 month (pdf)
- CRF 6 Week Visit (pdf)
- CRF Ulcer Healed (pdf)
- CRF Adverse Event (pdf)
- CRF Serious Adverse Event (pdf)
- CRF Protocol Deviation (pdf)
- CRF Trial Completion (pdf)
- Aberdeen Varicose Vein Questionaire (pdf)
- EQ-5D (pdf)
- SF36(pdf)
Site Handbook:
Screening Log:
INFORM Documents:
- Ensuring the casebook is SDV ready
- Internet Explorer 8 compatibility guidance
- Marking a form as not applicable guidance
- SDV ready
- User Activation Form
Newsletters:
- Newsletter Issue 1 (pdf)
- Newsletter Issue 2 (pdf)
- Newsletter Issue 3 (pdf)
- Newsletter Issue 4 (pdf)
- Newsletter Issue 5 (pdf)
- Newsletter Issue 6 (pdf)
- Newsletter Issue 7 (pdf)
- Newsletter Issue 8 (pdf)
- Newsletter Issue 9 (pdf)
- Newsletter Issue 10 (pdf)
- Newsletter Issue 11 (pdf)
Reminder Bulletins:
- Reminder Bulletin 1 (pdf)
- Reminder Bulletin 2 (pdf)
- Reminder Bulletin 2 - Randomisation Procedure and Troubleshooting (pdf)
- Reminder Bulletin 3 (pdf)