TIER

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 TIER Trial Office.

Current Essential Documents

• Protocol [.pdf]
• Patient Information Sheet [.docx]
• Legal Representative Information sheet [.docx]
• Informed Consent Form [.docx]
• Legal Representative Consent Form [.docx]
• GP Letter  [.docx]
• Release of medical information form [.docx]

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 v6.0 - Investigator Site folder [pdf]

Previous

• Version Control Checklist v5.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v4.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v3.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v2.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v1.1- Investigator Site Folder [.pdf]
• Version Control Checklist v1.0- Investigator Site Folder [.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

• TIER trial Guidelines  [.pdf]
• MRI Manual  [.pdf]
• Sample Collection manual  [.pdf]

Case Report Forms

• Adverse Event form [.pdf]
• Baseline form [.pdf]
• Concomitant Medication form [.pdf]
• Consolidation form [.pdf]
• Death Form [.pdf]
• Deviation form [.pdf]
• DLT form [.pdf]
• Eligibility form [.pdf]
• Follow-up form [.pdf]
• MRI form [.pdf]
• Pregnancy notification form [.pdf]
• Registration form (v1.0a) [.pdf]
• TIER Treatment form [.pdf]
• Treatment discontinuation form [.pdf]
• Treatment form Cycle 1 [.pdf]
• Treatment form Cycle 2 [.pdf]
• Withdrawal of consent [.pdf]
• Blood sample collection fom [.pdf]
• CSF sample collection form [.pdf]
• Tissue sample collection form [.pdf]

• SAE Fax Cover Sheet  [.pdf]
• SAE form [.pdf]
• SAE coded tables [.pdf]

Activity of Daily living questionnaires:

• Physcial [.pdf]
• Intsrumental [.pdf]
• MMSE [.pdf]

Pharmacy Documents

• Pharmacy Manual [.pdf]
• Thiotepa order form [.pdf]
• Thiotepa SPC [.pdf]
• Ifosfamide SPC [.pdf]
• Etoposide SPC [.pdf]
• Mabthera SPC [.pdf]
• Rixathon SPC [.pdf]
• Truxima SPC [.pdf]

Pharmacy File Version Control Checklists

• Version Control Checklist v7.0 - Pharmacy Folder  [pdf]
• Version Control Checklist v6.0 - Pharmacy Folder  [pdf]
• Version Control Checklist v5.0 - Pharmacy Folder  [pdf]
• Version Control Checklist v4.0 - Pharmacy Folder [.pdf]
• Version Control Checklist v3.0 - Pharmacy Folder [.pdf]
• Version Control Checklist v2.0 - Pharmacy Folder [.pdf]
• Version Control Checklist v1.0 - Pharmacy Folder [.pdf]

To date there are no publications for this trial.

No current news or upcoming events

Tier Newsletters

• May 2017 [.pdf]
• January 2017 [.pdf]
• October 2016 [.pdf]
• June 2016 [.pdf]
• July 2015 [.pdf]

Tier Flyers

• October 2017 [.pdf]

 

Chief Investigator:
Dr Christopher Fox
Centre for Clinical Haematology
Nottingham University Hospitals (City Campus)
Hucknall Road
Nottingham
NG5 1PB

 Email: Tier@trials.bham.ac.uk

Tel: +44 (0)115 969 1169
Fax:+44 (0)115 993 6635

TIER Trial Office     

Trial Coordinator:  Louise Hopkins
Trial Monitor:  Poonam Patel / Semsem Abdulle
Trial Management Team Leader:  Sonia Fox
Trial Statistician:  Anesh Panchal

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:         Tier@trials.bham.ac.uk

Trial Entry
Telephone: +44 (0)121 414 7673

Serious Adverse Event Reporting
Fax:  +44 (0)121 414 6061

Trial Sponsor
Unversity of Birmingham