Amendment 13

Study Amendment 13 to BADBIR has an implementation date of 06/03/2023

Documents in this amendment

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

Download all amendment 13 files

If you would like the tracked changes versions of the documents to see exactly what's changed since the last amendment, you can download the file below.

Download tracked changes amendment 13 files

Site file documents

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

Section Details Version Date
Section 1: Protocol BADBIR Protocol 20 01/08/2022
Section 2: PIL Participants over 16 years of age:
Patient Information Sheet* 5.3 01/08/2022
Patient Consent Form* 5.3 01/08/2022
Participants under 16 years of age:
Children's Information Sheet 2.2 01/08/2022
Very Young Children's Information Sheet 2.2 01/08/2022
Young Person's Information Sheet 2.2 01/08/2022
Patient Assent Form* 5.3 01/08/2022
Participant Consent Form (parent or guardian)* 5.3 01/08/2022
Other Documents:
Patient Portal Invitation Letter* 1 01/08/2022
Section 3: Regulatory and other essential documents Amendment Tool for Substantial Amendment 13 (non-CTIMP) 13 01/08/2022
HRA Approval 13 19/01/2023
REC Approval 13 19/01/2023

Other documents

Name Version Date
Clinical Baseline Questionnaire 11 01/08/2022
Clinical Follow-Up Questionnaire 11 01/08/2022
Patient Baseline Questionnaire 6 01/08/2022
Patient Follow-Up Questionnaire 7 01/08/2022
Under 16 Patient Baseline Questionnaire 2 01/08/2022
  • Please be aware that 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.