EPIVIN: For Investigators

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. Return both documents to the EPIVIN Trial Office.

• EPIVIN Training Log [.pdf]
• Site Staff Registration Form [.pdf]
• Site Staff Signature and Delegation Log [.pdf]

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.

• Amendment 1, 12-Feb-2015  [Opens a New Page]
• Amendment 2, 14-May-2015   [Opens a New Page]
• Amendment 3, 13-Aug-2015 [Opens a New Page]
• Amendment 5, 18-Jan-2016 [Opens a New Page]

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]

Chief Investigator
Professor David Luesley
Contact via the SWBH switchboard on 0121 554 3801

EPIVIN Trial Office
Trial Coordinator:                                            Baljit Kaur
Trial Monitor:                                                   Poonam Patel
Trial Management Team Leader:                 Sarah Bowden
Trial Statistician:                                              Daniel Slade

Cancer Research UK Clinical Trials Unit (CRCTU)
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries
Tel:      (+44) 0 121 414 5102
Fax:      (+44) 0 121 414 2230
Email:  EPIVIN@trials.bham.ac.uk

Trial Entry
Tel: 0800 371 969    (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting
Fax: 0121 414 2230  or  0121 414 3700

Sponsor
The University of Birmingham,
Edgbaston
Birmingham
B15 2TT

Sandwell & West Birmingham Hospitals NHS Trust
Dudley Road
Birmingham
B18 7QH