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 VIOLA Trial Office.
- Protocol version 5.0 05-Apr-2016 [.pdf]
- Patient Information Sheet version 6.0 04-Feb-2016 [.pdf]
- Informed Consent Form version 6.0 04-Feb-2016 [.pdf]
- GP Letter version 3.0 28-Mar-2014 [.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.
- Version Control Checklist - Investigator Site Folder version 6.0 23-Apr-2018 [.pdf]
- Version Control Checklist - Investigator Site Folder version 5.0 10-Oct-2016 [.pdf]
- Version Control Checklist - Investigator Site Folder version 4.0 05-Nov-15 [.pdf]
- Version Control Checklist - Investigator Site Folder version 3.0 08-Jul-14 [.pdf]
- Version Control Checklist - Investigator Site Folder version 2.0 25-Jun-14 [.pdf]
- Version Control Checklist - Pharmacy Folder version 4.0 19-Sep-14 [.pdf]
- Version Control Checklist - Pharmacy Folder version 3.0 30-May-14 [.pdf]
- Version Control Checklist - Pharmacy Folder version 2.0 22-May-14 [.pdf]
- Version Control Checklist - Pharmacy Folder version 1.0 10-Mar-14 [.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 01 [opens new page]
Amendment 02 [opens new page]
Amendment 03 [opens new page]
Amendment 04 [opens new page]
Amendment 05 - Addition of new site only
Amendment 06 - Update to Reference Safety Information only
Case Report Forms
- Registration Form [.pdf]
- Eligibility Form [.pdf]
- Baseline Form [.pdf]
- AML Disease History Form [.pdf]
- MDS Disease History Form [.pdf]
- Treatment Cycle 1 Form [.pdf]
- Treatment Cycle 2-6 Form [.pdf]
- Subsequent Cycle Form [.pdf]
- 28 Days from End of Treatment Form [.pdf]
- 1 Year from End of Treatment Form [.pdf]
- Adverse Event Form [.pdf]
- Acute GvHD Form [.pdf]
- Chronic GvHD Form [.pdf]
- Immunosuppressant Concomitant Medication Form [.pdf]
- Treatment Discontinuation Form [.pdf]
- Withdrawal Form [.pdf]
- Deviation Form [.pdf]
- Death Form [.pdf]
- SAE Form [.pdf]
- Pregnancy Notification Form [.pdf]
Guidelines
- Sample Collection Guidelines [.pdf]
- SAE Form Completion Guidelines [.doc]
Other Trial Documents
- Pharmacy Manual [.pdf]
- SAE Fax Cover Sheet [.pdf]
- SmPCs
- Azacitidine SmPC [.pdf]
- Lenalidomide SmPC [.pdf]