AZTEC

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(s), Informed Consent Form(s) 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 AZTEC Trial Office.

• Protocol version 3.0 11-Jul-17 [.pdf]
• Patient Information Sheet version 4.0 05-Jul-18 [.pdf]
• Informed Consent Form version 3.0 02-Dec-16 [.pdf]
• GP Letter version 1.0 30-Jul-15  [.pdf]

 

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.

• ISF checklist v5.0 17-Aug-2018 [.pdf]

• Pharmacy version control v3.0 26-Apr-2018 [.pdf]

 

Amendments

 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.

• Amendment 01 - Addition of new site/change of PI only
• Amendment 02 - Change of site/PI details only
• Amendment 03 [opens new page]
• Amendment 04 [opens new page]
• Amendment 05 [opens new page]

 

Case Report Forms

• Registration form
• Elligibility form
• Disease History form
• Baseline form
• Treatment cycle form
• GvHD Assessment form
• Adverse Event form
• Concomitant Medication form
• End of Treatment form
• Month 3 and 6 Follow up visit form
• Death form
• Treatment Discontinutation form
• Deviation form
• Withdrawal form
  
• SAE form

 

 Guidelines

• eCRF User Manual
• SAE completion guidelines
• Sample collection guidelines

 

Other Trial Documents

• Pharmacy manual
• SAE fax cover sheet
• SmPC - Azacitadine

No publications to date

• Newsletter - June 2018
• Newsletter - March 2018
• Newsletter - June 2017
• Newsletter - June 2016

Chief Investigator

Dr Ram Malladi
Senior Lecturer/Consultant Haematologist
Centre for Clinical Haematology
Queen Elizabeth Hospital
Birmingham
B15 2TH

Tel: +444 (0)121 371 4365
Fax: +44 (0)121 371 4398
Email: ram.malladi@uhb.nhs.uk

AZTEC Trial Office
Trial Coordinator: Tina McLeod                          
Trial Monitor: Karen James                            
Trial Management Team Leader: Shamyla Siddique 
Trial Statistician: Ikhlaaq Ahmed                            

Centre for Clinical Haematology
Research Office
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH

Enquiries
Telephone: +44 (0)121 371 4365
Fax:             +44 (0)121 371 7874
Email:         AZTEC@trials.bham.ac.uk

Serious Adverse Event Reporting
Fax: +44 (0)121 371 7874

Sponsor

University of Birmingham

Correspondence to:
Cancer Research UK Clinical Trials Unit (CRCTU)
University of Birmingham
Edgbaston
Birmingham
B15 2TT