HR-NBL2: For Investigators

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. Return both documents to the HR-NBL2 Trial Office.

• Investigator Registration Form [.pdf 702KB]
• Site Staff Registration Form [.pdf 620KB]
• Site Signature Delegation Log v2.0 [.pdf 230KB]
• HR-NBL2 Sponsor Database Request Form v1.0_22-Jul-2021 [.pdf 73KB]

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 please email the HR-NBL2 Trials Office.

• HR-NBL2 Protocol v1.1 19 Jul 2018 [.pdf 3656KB]
• HR-NBL2 Synopsis v1.1 19 Jul 2018 [.pdf 301KB]

Patient Documents

• HR-NBL2_Main Study Entry PIS_Parent-Guardian_v2.0 31-Oct-2022 [.pdf 909KB] 
• HR-NBL2_Main Study Entry PIS_Patients Aged 16+_v2.0 31-Oct-2022 [.pdf 906KB]
• HR-NBL2_Main Study Entry PIS_Patients Aged 13-15_v2.0 31-Oct-2022 [.pdf 755KB]
• HR-NBL2_8-12 Years PIS_v1.0_26-Aug-2020 [.pdf 561KB]
• HR-NBL2_Induction PIS_Parent Guardian_v1.0 27-Aug-2020 [.pdf 1022KB]
• HR-NBL2_Induction PIS_Patients Aged 16+_v1.0_27-Aug-2020 [.pdf 785KB]
• HR-NBL2_Induction PIS_Patients Aged 13-15_v1.0_27-Aug-2020 [.pdf 686KB]
• HR-NBL2_Consolidation PIS_Parent Guardian_v1.0_07-Sep-2020 [.pdf 447KB]
• HR-NBL2_Consolidation PIS_Patients Aged 16+_v1.0_07-Sep-2020 [.pdf 784KB]
• HR-NBL2_Consolidation PIS_Patients Aged 13-15_v1.0_28-Aug-2020 [.pdf 684KB]
• HR-NBL2_Radiotherapy PIS_Parent Guardian_v1.0_08-Sep-2020 [.pdf 892KB]
• HR-NBL2_Radiotherapy PIS_Patients Aged 16+ Years_v1.0_08-Sep-2020 [.pdf 695KB]
• HR-NBL2_Radiotherapy PIS_Patients Aged 13-15_v1.0_08-Sep-2020 [.pdf 685KB]

• HR-NBL2_Parent-Guardian Main Study Entry_ICF_v1.0_27-Aug-2020 [.pdf 234KB]
• HR-NBL2_16+ Years Main Study Entry_ICF_v1.0_27-Aug-2020 [.pdf 46KB]
• HR-NBL2_Parent-Guardian_Subsequent Randomisations_ICF_v1.0_27-Aug-2020 [.pdf 368KB]
• HR-NBL2_16+ Years_Subsequent Randomisations_ICF_v1.0_27-Aug-2020 [.pdf 280KB]

• HR-NBL2_GP Letter - Induction_v1.0_12-Jun-2020 [.pdf 378KB]
• HR-NBL2_GP Letter - Consolidation_v1.0_12-Jun-2020 [.pdf 364KB]
• HR-NBL2_GP Letter - Radiotherapy_v1.0_24-Jun-2020 [.pdf 364KB]

• HR-NBL2 Patient ID Cards v1.0 12-Jun-2020 [.pdf 419KB]
• HR-NBL2_RMIF_v1.0a_20-Oct-2020 [.pdf 404KB]

Version Control Lists

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.

• HR-NBL2 Version Control List v7.0 vd 14-Feb-2023 [.pdf 264KB]

Amendments

Below will be  links to documents 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.

• SA-06 - 20-Apr-2023 - USM Protocol Appendix and PIS update
• SA-05 - 01-Mar-2023 - Patient Videos
• SA-04 - 31-Oct-2022 - PIS update
• SA-03 - 17-Mar-2021 - Not required for sites 
• SA-02 - 05-Oct-2020 - Update to CTA 

Case Report Form

• HR-NBL2 Case Report Forms (current) [pdf 2369KB]

Guidelines

• HRNBL-2_trial_master_user_manual v5.0 [.pdf 1143KB]
• My eclinical user guide [.pdf 1720KB]
• SAE form instructions [.pdf 39KB]
• Validation of SAEs in My eclinical [.pdf 609KB]

Other Trial Documents

• HR-NBL2 Pharmacy Manual v1.0 19-Feb-2021 [.pdf 940KB]

• Newsletter Issue 1 [.pdf 953KB]

Chief Investigator

Dr Dominique Valteau-Couanet

Institut Gustave Roussy
114 rue Edouard Vaillant
94 805 Villejuif
France

UK Lead Investigator

Dr Martin Elliott                                                                          

Consultant Paediatric Oncologist, Leeds General Infirmary

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

Tel: +44 (0) 121 414 3799

Email: Martin Elliott

 

HR-NBL2 Trial Office

Trial Coordinator:  Hannah Jeffery / Salma Iqbal
Trial Administrator: Faiza Suleman
Senior Trial Coordinator:  Jennifer Laidler
Trial Management Team Leader:  Charlotte Firth

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

 Enquiries

Telephone: +44 (0) 121 414 3799 or +44 (0) 121 415 8211
Fax: +44 (0) 121 414 9520
Email: HighRisk-NBL2@trials.bham.ac.uk

Randomisation service supplied by the Sponsor Gustave Roussy, France

Randomisation should be performed by sites online at:

https://trials.siopen-r-net.org/ 

In case of any problems with online randomisation, contact the Trial Office.

 

Serious Adverse Event Reporting

SAE's should be Reported on the my-eclinical web portal:

https://www.evereport.eu/myeclinical/form/IGR/login.php

In case of any problems, email: reg@trials.bham.ac.uk.

 

Sponsor

Institut Gustave Roussy

CRCTU Home Page

http://www.birmingham.ac.uk/crctu