PHITT: For Investigators

Paediatric Hepatic International Tumour Trial - PHITT

Change of Staff

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 PHITT Trial Office.

Trial Documents

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 PHITT Trials Office.

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.

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-03 - Urgent Safety Measure Protocol v2.0 [link opens in popup]
  • SA-04 Change of PI Oxford [link opens in popup]
  • SA-05 Change of PI Southampton [link opens in popup]
  • A-06 Non substantial ammendment Protocl v2.0a vd17-Jan-2018 [link opens in popup]
  • SA-07 Addition of new site, Kings College London [link opens in popup]

Case Report Form

Guidelines

Other Trial Documents

Summary of Product Characteristics

 

Contact Details

Chief Investigator

Professor Bruce Morland                                                                                  

Cancer Research UK Consultant in Paediatric Oncology

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

Tel: +44 (0) 121 414 1061

Email: Bruce Morland

PHITT Trial Office

Senior Trial Coordinator: Jennifer Laidler
Trial Coordinator:  Steve Baker
Trial Administrator:  Duncan Gordon
Data Manager: Neil Werrett
Trial Monitor:  Jennifer Keely
Trial Management Team Leader:  Nicola Fenwick
Trial Statistician:  Veronica Moroz

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

Enquiries

Telephone: +44 (0) 121 415 1061 or +44 (0) 121 415 8211
Fax: +44 (0) 121 414 9520
Email: phitt@trials.bham.ac.uk

Trial Entry - Currently registration and randomisation should be performed via the Trial Team by calling +44 (0) 1214158211 or +44 (0) 1214151061

Randomisation service supplied by the CRCTU at the University of Birmingham

Randomisation should be performed by sites online at:

https://www.chilternproject.eu/study/CHI

In case of any problems with online randomisation, randomisation can be performed via the telephone by the CRCTU on:

Tel: +44 (0) 121 425 8211 or Tel: +44 (0) 121 415 1061

Serious Adverse Event Reporting

SAE's should be faxed to the PHITT Trial Office, CRCTU, University of Birmingham, UK

Fax: +44 (0) 121 414 9520 or +44 (0) 121 414 3700

Sponsor

University of Birmingham

CRCTU Home Page

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