ROMAZA

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 ROMAZA Trial Office.

• Protocol [.pdf]
• Trial Summary [.pdf]

Patient Documents

• Patient Information Sheet [.docx]
• Informed Consent Form [.docx]
• GP Letter  [.pdf]
• Release of Medical Information Form [.docx]
• Patient Screening and Enrolment log [.pdf]
• Patient Identification Log [.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 [.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 Archive (opens new page)

 Guidelines

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

Other Trial Documents

• Pharmacy Manual [.pdf]

Case Report Form

• Registration Form[.pdf]
• Eligibility Form [.pdf]
• Baseline Form  [.pdf]
• Disease History Form [.pdf]
• Treatment Cycle Form  [.pdf]
• 28 Days from End of Treatment Form [.pdf]
• DLT Form [.pdf]
• Adverse Events Form  [.pdf]
• Treatment Discontinuation Form  [.pdf]
• Withdrawal Form  [.pdf]
• Notification of Death Form  [.pdf]
• Deviation Form  [.pdf]
• Pregnancy Notification Form  [.pdf]
• SAE Form  [.pdf]

• SAE Fax Cover Sheet [.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

ROMAZA Trial Office
Trial Coordinator:  Emmanouela Gbandi                            
Trial Monitor:  Kavita Mistry                                    
Trial Management Team Leader:  Shamyla Siddique                        

Cancer Research UK Clinical Trials Unit (CRCTU) [opens a new window]
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

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

Trial Entry
Telephone: +44  (0)121 414 9273   (9:00am to 5:00pm Monday to Friday)

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

Sponsor: University of Birmingham