Links to the current protocol, UK 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. UK Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, UK GP Letter, Release of Medical Information Form etc) can also be found below.
If you cannot find what you are looking for please email the MyeChild 01 Trials Office.
For non UK documentation please contact your National Coordinating Centre. Details can be obtained from the MyeChild 01 Trials office.
Protocol and Trial Synopsis
For the current protocol and trial synopsis, please refer to the home page [link]
Other Trial Related Documents
- MyeChild 01 Laboratory Manual v3.0 21-Nov-2016 (PDF 563KB)
- MyeChild-01 Pharmacy Manual v3.0 22-Nov-2016 (PDF 743KB)
- For the Laboratory Manual for PK and ADA Assessments, please email the MyeChild 01 Trials Office.
Guidelines
- SAE Form Completion Guidelines_v1.0_17Mar16 (PDF 164KB)
- CRF Completion Guidelines v2.0 19-Jul-2017 (PDF 477KB)
- eRDC User Manual v1.0 29-Sep-2016 (PDF 1539KB)
Case Report Forms
Patient Information Sheets
Informed Consent Forms
GP Letters
Release of Medical Information
- Release of Medical Information (MS Word Document 699KB)
Version Control Lists
- Investigator Site File and Pharmacy File Version Control Lists [link]
Amendments
The links 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.
Summary of Product Characteristics & Investigator's Brochure
Gemutuzumab Ozogamicin Order Form
This order form can be completed electronically. Once complete, order forms can be faxed or emailed to the MyeChild 01 Trials Office.
- Gemtuzumab Ozogamicin Order Form_v2.0_25-Aug-2017_editable (PDF 462KB)
Please be aware that contrary to the Pharmacy Manual; you do not need to notify the MyeChild 01 Trial Office of drug receipt.