Amendment 12

Documents in this amendment

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

Download all amendment 12 files

Site file documents

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

Section Details Version Date
Section 1: Protocol BADBIR Protocol 19 01/06/2020
Section 2: PIL Participants over 16 years of age:
Patient Information Sheet* 5.2 01/06/2020
Patient Consent Form* 5.2 01/06/2020
Participants under 16 years of age:
Patient Assent Form* 5.2 01/06/2020
Participant Consent Form (parent or guardian)* 5.2 01/06/2020
Other Documents:
Patient Invitation Letter* 2 01/06/2020
Patient Poster 2 01/06/2020
Section 3: Regulatory and other essential documents Amendment Tool for Substantial Amendment 12(non-CTIMP) 12 01/07/2020
HRA Approval 12 26/08/2020
REC Approval 12 26/08/2020

Other documents

Name Version Date
Clinical Baseline Questionnaire 10 01/06/2020
Clinical Follow-Up Questionnaire 10 01/06/2020
System Level Security Policy (SLSP) v3 10/12/2018

Zip File of Tracked Changes Documentation