RAvVA

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. 

• Investigator Registration Form[.pdf]
• Site Staff Registration Form [.pdf]
• 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 RAvVA Trial Office.

Protocol

• Protocol (v8.0) [.pdf]
• Trial Summary [.pdf]

Patient Documents

• Patient Information Sheet [.docx]
• Informed Consent Form [.docx]
• GP Letter  [.docx]
• Release of Medical Information Form [.docx]

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 v5.0 [.pdf]
• Version Control Checklist - Investigator Site Folder v4.0 [.pdf]
• Version Control Checklist - Investigator Site Folder v3.0 [.pdf]
• Version Control Checklist - Investigator Site Folder v2.0 [.pdf]
• Version Control Checklist - Investigator Site Folder v1.0 [.pdf]

• CRF Version Control v2.0 [.pdf]
• CRF Version Control v1.0 [.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.

• Summary of Amendments [.pdf] 
• RAvVA Amendments  (opens new page)

 Guidelines

• CRF Completion Guidelines v3.0   [.pdf]
• SAE Form Completion Guidelines  [.pdf]

Other Trial Documents

• Quality of Life Questionnaire [.pdf]
• Patient Indentification log [.pdf]
• Patient Screening & Enrolment Log [.pdf]

Case Report Forms

• Entire CRF [.zip]

• Randomisation Form  [.pdf]
• Eligibility Form [.pdf]
• AML Disease History Form  [.pdf]
• MDS Disease History form  [.pdf]
• Baseline Form  [.pdf]
• Treatment Form  [.pdf]
• Adverse Events Form  [.pdf]
• AML Response Assessment Form  [.pdf]
• MDS Response Assessment Form  [.pdf]
• Anti-infectives usage Form  [.pdf]
• Blood Product Usage Form  [.pdf]
• G-CSF Usage Form  [.pdf]
• Inpatient Admission Form  [.pdf] 
• Deviation Form  [.pdf]
• AML Follow Up Form  [.pdf]
• MDS Follow Up Form  [.pdf]
• Treatment Discontinuation Form  [.pdf]
• Withdrawal of Consent Form  [.pdf]
• Death Form  [.pdf]
• Pregnancy Notification Form  [.pdf]

• SAE Form  [.pdf]
• SAE Fax Cover [.pdf]

Pharmacy Documents

• Pharmacy Manual  [.pdf]

 

To date there are no publications for this trial.

No current news or upcoming events

Chief Investigator
Professor Charles Craddock
Centre for Clinical Haematology
Queen Elizabeth Hospital 
Edgbaston
Birmingham
B15 2TH

Tel:      +44 (0)121 371 4374
Fax:     +44 (0)121 371 4398

RAvVA Trial Office
Trial Coordinator:    Emmanouela Gbandi                                 
Trial Monitor:    Poonam Patel
Trial Management Team Leader:    Shamyla Siddique
Trial Statistician:    Aimee Houlton

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

Enquiries
Telephone: +44 (0)121 414 9273
Fax:             +44 (0)121 414 6061 
Email:          ravva@trials.bham.ac.uk

Serious Adverse Event Reporting

Fax: 0121 414 6061  Or  0121 414 3700

Sponsor
University of Birmingham

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