RomiCar

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 RomiCar Trial Office.

• Protocol [.pdf]
• Patient Information Sheet [.pdf]
• Informed Consent Form (v5.0a) [.docx]
• GP Letter  [.pdf]
• Release of Medical Information 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.

Current

• Version Control Checklist - Investigator Site Folder v5.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v5.0 [.pdf]

Previous

• 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]
• Version Control Checklist - Pharmacy Folder v4.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v3.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v2.0 [.pdf]
• Version Control Checklist - Pharmacy Folder 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.

• Amendments (opens new page)

Guidelines

• ICF Completion Guidelines  [.pdf]
• SAE Form Completion Guidelines  [.pdf]
• RomiCar Blood Sample collection and processing [.pdf]
• Circulating DNA protocol for RomiCar [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]

Case Report Forms

• Registration Form [.pdf]
• Eligibility Form [.pdf]
• Screening Form  [.pdf]
• Treatment Form  [.pdf]
• Treatment Continuation Form [.pdf]
• Concomitant Medication Form  [.pdf]
• Adverse Events Form  [.pdf]
• Treatment Discontinuation Form  [.pdf]
• End of Treatment Form  [.pdf]
• Withdrawal Form  [.pdf]
• Disease Progression Form [.pdf]
• Notification of Death Form  [.pdf]
• Deviation Form  [.pdf]
• Follow Up Form  [.pdf]
• Pregnancy notification Form [.pdf]

• Sample collection form [.pdf]

All CRFs [.zip]

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

To date there are no publications for this trial.

RomiCar newsletters

• January 2017 [.pdf]
• Autumn 2016 [.pdf]
• June 2016 [.pdf]
• Christmas 2015 [.pdf]
• July 2015  [.pdf]

Chief Investigator
Graham Collins

Consultant Haematologist, Honorary Senior Clinical Lecturer in Haematology

Oxford Cancer and Haematology Centre, Churchill Hospital, Old Road,Oxford, OX3 7EJ

Tel:      +44 (0) 1865 235886
Fax:     +44 (0) 1865 235260
Email: graham.collins@ouh.nhs.uk

RomiCar Trial Office
Trial Coordinator:                                Eszter Nagy               
                               
Trial Monitor:                                       Poonam Patel          
Trial Management Team Leader:       Shamyla Siddique
Trial Statistician:                                 Kristian Brock

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 7673
Fax:             +44 (0)121 414 6061
Email:         romicar@trials.bham.ac.uk

Trial Entry
Telephone:0121 414 7673                                                               (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting
Fax: 0121 414 6061                                                 or                                                0121 414 3700

Sponsor  University of Birmingham