Trial Documentation

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

The PREDNOS trial is now open to recruitment. Please use the links below to download PREDNOS documentation.


PREDNOS Protocol

PREDNOS Protocol v2.0 (7th April 2011)

PREDNOS PIS/GP Letters/Consent Forms

PREDNOS Letter to GP v1.0 (01/09/10)

PREDNOS Parent Information Sheet v1.1 (01/02/11)

PREDNOS Assent Form v1.0 (01/09/10)

PREDNOS Parent Consent Form v1.1 (01/02/11)

PREDNOS Older Child Information Sheet v1.1 (01/02/11)

PREDNOS Younger Child Information Sheet v1.1 (01/02/11)

 

PREDNOS Appendices

Appendix 1: PREDNOS Trial Schema v1 (01/09/10)

Appendix 2: PREDNOS Expected AEs Prednisolone v1 (01/09/10)

Appendix 3: PREDNOS Unblinding Procedure v1 (01/09/10)

Appendix 4: PREDNOS Parent Information Sheet v1.1 (01/02/11)

Appendix 5:PREDNOS Older Child Information Sheet v1.1 (01/02/11)

Appendix 6: PREDNOS Younger Child Information Sheet v1.1 (01/02/11)

Appendix 7: PREDNOS Parent Consent Form v1.1 (01/02/11)

Appendix 8: PREDNOS Assent Form v1.0 (01/09/10)


PREDNOS CRFs

Please use the links below for copies of the following forms:

Follow Up Form v1.0 (07/04/11)

Follow Up Form Continuation v1.0 (07/04/11)

Patient Diary Weeks 4-16 v1.1 (05/04/11)

Randomisation Notepad v1.0 (07/04/11)

Serious Adverse Event Form v1.0 (05/04/11)

Please contact us for copies of the following forms (we cannot add these questionnaires to the website for download as they are copyright protected):

Achenbach

CHU 9D

PedsQL

Please ensure you use the correct form for the age of the patient:

Table of Questionnaires Completed by Age