VERITAS: 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 VERITAS Trial Office.

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Site Signature Delegation Log v1.0 [.pdf]

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 VERITAS Trials Office.

• VERITAS Protocol v2.0 18 Aug 2018 [.pdf]
• VERITAS Synopsis v2.0 18 Aug 2018 [.pdf]
• VERITAS PIS 8-12yrs v2.0 vd28 May 2019 [.pdf] 
• VERITAS PIS 13-15yrs v2.0 vd28 May 2019 [.pdf]
• VERITAS PIS 16+yrs v3.0a vd28 Apr 2020 [.pdf]
• VERITAS PIS Parent-Guardian v3.0a vd28 Apr 2020 [.pdf]
• VERITAS Patient Informed Consent Form (Over 16) v2.0 vd28 May 2019 [.pdf]
• VERITAS Parent-Guardian Informed Consent Form v2.0 vd28 May 2019 [.pdf]
• VERITAS_Child Assent Form_v1.0_22-May-2019 [.pdf]
• VERITAS GP Letter v1.0 21Nov2018 [.pdf]
• Release of Medical Information Form v1.0 30-Jan-2017 [.pdf]
• VERITAS_Patient_ID_Card_v1.0 18Dec2018 [.pdf]

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 in reverse date order.

• VERITAS Version Control List v4.0 vd14 Oct 2021 [.pdf]

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-09 - 17-Mar-2021 - Change of PI at UCLH
• SA-08 - 05-Oct-2020 - Change of PI at Oxford

Case Report Form

• VERITAS Case Report Forms (current) [pdf]

Guidelines

• Instructions for completion of the SAE form [.pdf]
• My eclinical user guide v2.0 vd 18Jan 2016 [.pdf] 
• Validation of SAEs reports via my-clinical by the investigator [.pdf]
• VERITAS User Manual v1.0  [.pdf]

Other Trial Documents

• VERITAS Pharmacy Manual v2.0 30-Jun-2020 [.pdf]

• Newsletter Issue Jan 2021 [.pdf]
• Newsletter Issue Aug 2021 [.pdf]
• Newsletter Issue May 2022  [.pdf]

Chief Investigator

Dr Dominique Valteau-Couanet

Gustave Roussy

114 rue Edouard Vaillant94 805 VillejuifFrance

 

UK Lead Investigator

Dr Guy Makin                                                                           

Honorary Consultant Paediatric Oncologist, Royal Manchester Children's Hospital and Christie Hospital

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: Guy Makin

 

VERITAS Trial Office

Trial Coordinator:  Salma Iqbal
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: veritas@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

Gustave Roussy

CRCTU Home Page

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