Links to the current protocol, Patient Information Sheet, Informed Consent Form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.
Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the EPIVIN Trial Office.
- Trial protocol [.pdf]
- Trial summary [.pdf]
- Patient Information Sheet [.pdf]
- Informed Consent Form [.pdf]
Version Control Lists
The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Version Control Lists used in this trial are below in reverse date order.
- Document Version Control Checklist v1.0 08-Sep-2014 [.pdf]
- Document Version Control Checklist v1.1 11-Sep-2014 [.pdf]
- Document Version Control Checklist v2.0 24-Mar-2015 [.pdf]
- Document Version Control Checklist v3.0 29-Apr-2015 [.pdf]
- EPIVIN Document Version Control Checklist v4.0 20-May-15 [.pdf]
- EPIVIN Document Version Control Checklist v6.0 08-Jul-2015 [.pdf]
- EPIVIN Document Version Control Checklist v7.0 [.pdf]
- EPIVIN Document Version Control Checklist v8.0 [.pdf]
- EPIVIN Document Version Control Checklist v9.0 [.pdf]
Amendments
Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.
Case Report Form
- CRF Baseline Form 04-Nov-2015 [.pdf]
- CRF Death Form 17-Mar-2015 [.pdf]
- CRF Deviation Form 17-Mar-2015 [.pdf]
- CRF Follow Up from Week 32 and 52 04-Nov-2015 [.pdf]
- CRF Histology Form 17-Mar-2015 [.pdf]
- CRF Pregnancy Notification 17-Mar-2015 [.pdf]
- CRF Telephone Assesment Form 04-Nov-2015 [.pdf]
- CRF Tx Discontinuation Form 04-Nov-2015 [.pdf]
- CRF Unscheduled Visit Form 04-Nov-2015 [.pdf]
- CRF Visit Week Form Week 4 and 8 04-Nov-2015 [.pdf]
- CRF Visit Form Week 16 04-Nov-2015 [.pdf]
- CRF Withdrawal Form 17-Mar-2015 [.pdf]
- Eligibility Form 24-Jul-2015 [.pdf]
- Serious Adverse Event Form 28-Jul-2014 [.pdf]
- Randomisation From 09-Sep-2014 [.pdf]
Guidelines
- CRF Completion Guidelines [.pdf]
- Informed Consent Procedures [.pdf]
- SAE Form Completion Guidelines 25-Jul-2014 [.pdf]
Other Trial Documents
- Pharmacy Manual 29-Jul-2014 [.pdf]
- Dermatology Life Quality Index [.pdf]
- McGill Pain Questionnaire [.pdf]
- Summary of Product Characteristics [.pdf]