Documentation for Existing Centres

Prior to randomising patients, centres must have sent copies of their SSA approval, R&D approval, Site Agreement and completed Centre Registration Form (and CTA or equivalent if a non-UK centre) to the AML Trials Office.

AML16 Patient Record Book

AML16 Intensive Patient Record Book

AML16 Non-Intensive Patient Record Book

AML16 Randomisation Notepad

Randomisation Notepad Intensive 1st Randomisation

Randomisation Notepad Intensive 2nd Rand (Cons/Main)

Randomisation Notepad Non-Intensive LD Ara-C v LD Clofarabine v Sapacitabine

Other Trial Documenation

AML16 Change of Trial Staff Form

AML16 Serious Adverse Event Form

AML16 Trial Guides and Information

NCI Toxicity Criteria

AML16 PowerPoint Presentation (please contact AML Trials Office)

AML16 Important Reference Numbers and Dates

AML16 Lay Summary (please contact AML Trials Office)

AML16 Sample Requirements

AML16 Azacytadine - Gene methylation status assessment form

AML16 Online Randomisation Guide for External Users

AML16 Online Data Entry Guide for External Users

Per Patient Payments

There will not be any Per Patient Payments in the AML16 trial.