EE2012: For Investigators

For UK sites: 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 EE2012 Trial Office.

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Site Signature and Delegation log [.pdf]

 

 

For Non UK sites: contact your national co-ordinating centre.

Links to the current protocol, UK Patient Information Sheet, UK 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, Patient Information Sheets, GP Letter and Patient ID Card can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the EE2012 Trial Office.

• Protocol [.pdf]
• UK Patient Information Sheets [.zip]
• UK Informed Consent Forms [.zip]
• UK GP Letters [.zip]
• UK Patient ID Card and Medical Release From [.zip]
• Patient Identification Log [.pdf]
• Patient Screening Log [.pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control Log. Please see below for the current Version Control Log and a link to previous Version Control List.

• Version Control Log [.pdf]
• Previous Version Control Logs [.zip]

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.

• SA-01 (opens new page)
• SA-02 (opens new page)
• SA-03 (opens new page)
• SA-04 (opens new page)
• SA-05 (opens new page)
• SA-06 (opens new page)
• SA-07 (opens new page)
• SA-08 (opens new page)
• SA-09 (Sponsor use only)
• SA-10 (opens new page)
• SA-11 (opens new page)
• SA-12 (opens new page)
• SA-13 (Sponsor use only)

Case Report Form

• Case Report Forms [.pdf]
• R1 Eligibility checklist [.pdf]
• R1 Randomisation Form [.pdf]
• R2 Eligibility checklist [.pdf]
• R2 Randomisation Form [.pdf]

Serious Adverse Event and Expected SAR Forms

• SAE Form [.pdf]
• SAE Fax cover sheet [.pdf]
• SAE Form - additonal sheet [.pdf]
• Expected SAR Form [.pdf]

Trial Guidelines

• CRF Completion guidelines [.pdf]
• SAE Form Completion guidelines [.pdf]
• Expected SAR Completion guidelines[.pdf]
• Radiotherapy guidelines [.pdf]
• Surgery guidelines [.pdf]
• eRDC User Maual [.pdf]
• PBSC mobilisation and harvesting guidelines [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]
• SPC Vincristine [.pdf]
• SPC Ifosfamide [.pdf]
• SPC Doxorubicin [.pdf]
• SPC Etoposide [.pdf]
• SPC Actinomycin D [.pdf]
• SPC Cyclophosphamide [.pdf]
• SPC Busulfan [.pdf]
• SPC Melphalan [.pdf]
• SPC Zoledronic acid [.pdf]
• Laboratory Manual [.pdf]

To date there are no publications for this trial.

• EE2012 Newsletter September 2014

• EE2012 Newsletter December 2014

• EE2012 Newsletter March 2015

• EE2012 Newslewtter July 2015

• EE2012 Newsletter December 2015

• EE2012 Newsletter March 2016

• EE2012 Newsletter September 2016

• EE2012 Newsletter April 2017

• EE2012 Newsletter March 2018

Chief Investigator

Professor Bernadette Brennan

EE2012 Trial Office

Trial Coordinator:  Jean-Pierre Mahieu
Trial Monitor:  Shaneed Hajee
Trial Management Team Leader:  Nicola Fenwick

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

Enquiries

Telephone: +44 (0)121 415 9877 or +44 (0)121 414 3798
Fax: +44 (0)121 414 9520
Email: ee2012@trials.bham.ac.uk

Trial Entry

Randomisation is done online at site, if unavailable please contact below numbers

Telephone: +44(0)121 415 9877 or +44 (0)121 414 3798 (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting

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

Coordinating Sponsor

University of Birmingham