De-Iron

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 De-Iron Trial Office.

• Protocol [.pdf]
• Patient Information Sheet/Informed Consent Form [.pdf]
• Release of Medical Information Form [.pdf]
• GP Letter  [.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.

Current

• Version Control Checklist - Investigator Site Folder v8 08-Oct-2015 [.pdf]
• Version Control Checklist - Pharmacy Folder v9.0 08-Oct-2015 [.pdf]

Previous versions

• Version Control Checklist - Investigator Site Folder v7 28-Nov-2014 [.pdf]
• Version Control Checklist - Investigator Site Folder v6 29-may-2014 [.pdf]
• Version Control Checklist - Investigator Site Folder v5 13-Mar-2014 [.pdf]
• Version Control Checklist - Investigator Site Folder v4 09-Jan-2014 [.pdf]
• Version Control Checklist - Investigator Site Folder v3 10-Sep-2013 [.pdf]
• Version Control Checklist - Investigator Site Folder v2 20-Dec-2012 [.pdf]
• Version Control Checklist - Investigator Site Folder v1 29-Nov-2012 [.pdf]

 

• Version Control Checklist - Pharmacy Folder v8 28-Nov-2014 [.pdf]
• Version Control Checklist - Pharmacy Folder v7 04-Jun-2014 [.pdf]
• Version Control Checklist - Pharmacy Folder v6 29-May-2014 [.pdf]
• Version Control Checklist - Pharmacy Folder v5 13-Mar-2014 [.pdf]
• Version Control Checklist - Pharmacy Folder v4 13-Jan-2013 [.pdf]
• Version Control Checklist - Pharmacy Folder v3 01-Nov-2013 [.pdf]
• Version Control Checklist - Pharmacy Folder v2 10-Sep-2013 [.pdf]
• Version Control Checklist - Pharmacy Folder v1a 20-Dec-2012 [.pdf]
• Version Control Checklist - Pharmacy Folder v1 05-Dec-2012 [.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.

• Amendments  (opens new page)

Guidelines

• De-Iron Dosing Guidelines  [.pdf]
• De-Iron Trial Guidelines  [.pdf]
• Sample Collection Guideline [.pdf]
• MRI Guidelines [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]
• Patient ID log [.pdf]
• Screening enrolment log [.pdf]

Case Report Forms

• Registration Form[.pdf]
• Eligibility Form [.pdf]
• Screening Form [.pdf]
• Baseline Form  [.pdf]
• Treatment Assessments Form  [.pdf]
• Deferasirox Dosing Form [.pdf]
• Blood Transfusion Form [.pdf]
• MRI Form [.pdf]
• Concomitant Medication Form  [.pdf]
• Adverse Events Form  [.pdf]
• Treatment Discontinuation Form  [.pdf]
• 30 day follow-up Form  [.pdf]
• Withdrawal Form  [.pdf]
• Progression-Relapse Form [.pdf]
• Notification of Death Form  [.pdf]
• Pregnancy Notification Form [.pdf]
• Deviation Form  [.pdf]
• Off treatment Follow Up Form  [.pdf]
• Sample collection Form [.pdf]

CRF completion flowchart [.pdf]

All CRFs [.zip]

• SAE Form  [.pdf]
• SAE Fax cover sheet [.pdf]

To date there are no publications for this trial.

Most recent

• Newsletter 5 [.pdf]

Archive

• Newsletter 1 [.pdf]
• Newsletter 2 [.pdf]
• Newsletter 3 [.pdf]
• Newsletter 4  [.pdf]

Chief Investigator

Dr Dominic Culligan, Consultant Haematologist

NHS Grampian, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, AB25 2ZN

Tel: +44 (0)122 455 3394

Email: De-Iron@trials.bham.ac.uk  

 

De-Iron Trial Office
Trial Coordinator:  Yolande Jefferson                                             
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)121 415 9179
Fax:             +44 (0)121 414 6061
Email:         De-Iron@trials.bham.ac.uk

 

Serious Adverse Event Reporting
Fax: +44 (0)121 414 6061           or  +44 (0)121 414 3700

Sponsor

The trial is sponsored by the University of Birmingham.

The trial is being conducted under the auspices of the Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham according to their local procedures.