Amendment 10

Documents in this amendment

You can download all 14 of the files for this amendment in one go using the link below.

Download all amendment 10 files

Site file documents

* - these documents should be prepared on Trust-headed paper.

Section Details Version Date
Section 1: Protocol BADBIR Protocol 17 01/09/2017
Section 2: PIL Participants over 16 years of age:
Patient Information Sheet* (Word version) 5 01/08/2017
Patient Consent Form* (Word version) 5 01/08/2017
Participants under 16 years of age:
Patient Assent Form* (Word version) 5 01/08/2017
Participant Consent Form (parent or guardian)* (Word version) 5 01/08/2017
Participant Information Sheet (for children)* 2 01/08/2017
Participant Information Sheet (for young children)* 2 01/08/2017
Participant Information Sheet (for very young children)* 2 01/08/2017
Section 3: Regulatory and other essential documents Notice of Substantial Amendment (non-CTIMP) and Favourable Approval Letter* 10 11/09/2017
HRA IRAS Confirmation of Amendment Assessment 11/09/2017

Other documents

Name Version Date
Conditional Approval to Access Hospital Episode Statistics Data 24/03/2016
Clinical Baseline Questionnaire 9 01/08/2017
Clinical Follow-up Questionnaire 9 01/08/2017