Amendment 15

by | Aug 13, 2026 | Amendments | 0 comments

Study Amendment 15 to BADBIR has an implementation date of 23th September 2026.

Documents in this amendment

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

Download all amendment 15 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 (.zip).

Download all amendment 15 files

Site file documents

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

Section Details Version Date
Section 1: Protocol BADBIR Protocol 22 19/03/2026
Section 2: PIL Parent Guardian Consent Form* 5.4 19/03/2026
Patient Assent Form* 5.4 19/03/2026
Patient Consent Form* 5.4 19/03/2026
Patient Information Sheet* 5.4 19/03/2026
Section 3: Regulatory and other essential documents HRA Approval 15 19/03/2026
REC Approval 15 24/06/2026
Amendment Tool for Substantial Amendment 14 (non-CTIMP) 15 19/03/2026

Other documents

Name Version Date
Clinical Baseline Questionnaire 12 19/03/2026
Clinical Follow-up Questionnaire 12 19/03/2026

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.

0 Comments

Related