IMAT-Neuroblastoma: For Investigators

Investigator Registration Form

• IMAT-Neuroblastoma Investigator Registration Form v2.0 [.doc]

Site Staff Registration Form

• IMAT-Neuroblastoma Staff Registration Form v1.0 [.doc]

Links to the current protocol, Patient Information Sheet and 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 or require Word versions of the PIS and ICF for site localisation please email the IMAT-Neuroblastoma Trials Office.

Protocol

• IMAT-Neuroblastoma Protocol v3.0 vd15-May-2018 [.pdf]

RTTQA Guidelines

• This document is available directly from the RTTQA group website: www.rttrialsqa.org.uk or by contacting the RTTQA Group Trial Physicist

Patient Information Sheets

• IMAT-Neuroblastoma PIS Parent/Guardian v1.0 vd22-Jul-2016 [.pdf]

• IMAT-Neuroblastoma PIS Patient v1.0 vd22-Jul-2016 [.pdf]

• IMAT-Neuroblastoma PIS 13 - 15 v1.0 vd22-Jul-2016 [.pdf]

• IMAT-Neuroblastoma PIS 8 - 12 v1.0 vd22-Jul-2016 [.pdf]

Informed Consent Forms

• IMAT-Neuroblastoma ICF Parent/Guardian v1.0 vd08-Aug-2016 [.pdf]

• IMAT-Neuroblastoma ICF Patient v1.0 vd08-Aug-2016 [.pdf]

Version Control List

The version numbers and dates of all documents used for the trial are captured on a Version Control Log. Links to the Version Control Lists used in this trial are below in reverse date order

• IMAT-Neuroblastoma VCL v1.0 vd16-Feb-2017 [.pdf]

Other Trial Documents

GP Letter

• IMAT-Neuroblastoma GP Letter v1.0 vd22-Jul-2016 [.pdf]

Patient ID Card

• IMAT-Neuroblastoma ID Card v1.0 vd22-Jul-2016 [.pdf]

Case Report Form

• IMAT-Neuroblastoma CRF v1.0 vd07-Feb-2017 [.pdf]

• IMAT-Neuroblastoma Outlining Review Form v1.0 vd07-Feb-2017 [.pdf]

• IMAT-Neuroblastoma Planning Assessment Form v1.0 vd22-Feb-2017 [.xls]

Pharmacovigilance

• IMAT-Neuroblastoma SAE Form v1.0 vd07-Feb-2017 [.pdf]

• IMAT-Neuroblastoma SAE Form Completion Guidelines v3.0 vd13-Mar-2017 [.pdf]

• SAE Fax Cover sheet v1.0 vd07-Feb-2017 [.pdf]

REC Favourable Ethical Opinion

• REC FO Letter 21-12-2016 [.pdf]

HRA approval documentation

• HRA Approval email 17-Jan-2017 [.pdf]

• HRA Approval letter 17-Jan-2017 [.pdf]

HRA Schedules

• Schedule of Events v1.0 vd22-Jul-2016[.pdf]

• Staement of Activities v1.0 vd22-Jul-2016 [.pdf]

21st February 2017 - Trial opens at UCLH

22nd February 2017 - Trials opens at RMH & 1st patient randomised

14th August 2020 - Last patient randomised & trial closed to recruitment

Chief Investigator

Dr Mark Gaze                                                                                 

Cancer Research UK Consultant in Clinical Oncology

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

Tel: 0121 415 1060 

Email: mark.gaze@uclh.nhs.uk

IMAT- Neuroblastoma Trial Office

Trial Coordinator:  Salma Iqbal
Senior Trial Coordinator: Jennifer Laidler
Trial Management Team Leader:  Charlotte Firth

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

Enquiries

Telephone: 0121 415 1060
Email: IMAT@trials.bham.ac.uk

Central Review

Email: UCLH.IMATnbQA@nhs.net

Trial Entry

Randomisation service supplied by the CRCTU at the University of Birmingham

Randomisation can be performed over the phone by the CRCTU on:

Tel: 0121 415 1060

Serious Adverse Event Reporting

SAE's should be emailed to the IMAT-Neuroblastoma Trial Office, CRCTU, University of Birmingham, UK

reg@trials.bham.ac.uk

Sponsor

 University of Birmingham

CRCTU Home Page

 http://www.birmingham.ac.uk/crctu