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]