Amendment 12

Study Amendment 12 to BADBIR has implementation date of 06/10/2020

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

  • Please be aware that occasionally BABDIR may make minor changes to the Clinical Baseline Questionnaire and the Clinical Follow-Up Questionnaire outside of amendments. Please check the ‘Questionnaires’ section within the database for the latest versions.