Trial Documentation

Protocol

These documents are for use by collaborators involved in the GloMY trial. They are the property of the University of Birmingham and University Hospital Birmingham NHS Foundation Trust and do not constitute any form of advice to participants.

The GloMY trial is now open to randomisation. Please use the links below to download GloMY trial documentation.


GloMY Protocol

GloMY Protocol Version 3.2 (Jan 3rd 2012)

GloMY CRFs

Randomisation Notepad Form V3.2 (Jan 3rd 2012)

Follow Up Data Form V3.1 (Aug 1st 2011)

SAE Form

GloMY Appendices

Appendix 1: Trial Schema v3.2 (03/01/12)

Appendix 2: IgA Nephropathy Classification v2.1 (17/05/10)

Appendix 3: FSGS Patient Information Sheet v3.1 (01/08/11)

Appendix 4: FSGS Patient Consent Form v3.1 (01/08/11)

Appendix 5: IgA Nephropathy Patient Information Sheet v3.1 (01/08/11)

Appendix 6: IgA Nephropathy Consent Form v3.1 (01/08/11)

Appendix 7: Sample GP Letter v2.1 (17/05/10)

Appendix 8: Randomisation Notepad v3.2 (03/01/12)

Appendix 9: Steroid Taper Schedule v2.1 (17/05/10)

Appendix 10: Follow Up Data Collection Form v3.1 (01/08/11)

Appendix 11: Renal Biopsy Patient Information Sheet v2.1 (17/05/10)

Appendix 12: Renal Biopsy Consent Form v2.1 (17/05/10)

Appendix 13: Sample Renal Biopsy GP Letter v2.1 (17/05/10)

Appendix 14: Expected Adverse Events v2.1 (17/05/10)

Appendix 15: Serious Adverse Event Form v2.1 (17/05/11)

Appendix 16: Guidelines for Blood and Urine sample preparation v3.2 (03/01/12) 

Other Trial Documentation

Change/Addition of Staff Form

Randomisation Procedure

Data Entry Procedure

Samples Procedure