Amendment 11

by | Jun 21, 2018 | Amendments | 0 comments

Study Amendment 11 to BADBIR was approved on 31/08/2018.

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 11 files

Site file documents

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

Section Details Version Date
Section 1: Protocol BADBIR Protocol 18 01/06/2018
Section 2: PIL Participants over 16 years of age:
Patient Information Sheet* (Word version) 5.1 01/08/2017
Patient Consent Form* (Word version) 5.1 01/08/2017
Participants under 16 years of age:
Patient Assent Form* (Word version) 5.1 01/08/2017
Participant Consent Form (parent or guardian)* (Word version) 5.1 01/08/2017
Participant Information Sheet (for children)* 2.1 01/08/2017
Participant Information Sheet (for young children)* 2.1 01/08/2017
Participant Information Sheet (for very young children)* 2.1 01/08/2017
Section 3: Regulatory and other essential documents Notice of Substantial Amendment (non-CTIMP) and Favourable Approval Letter* 11 31/08/2018
HRA IRAS Confirmation of Amendment 11 Assessment   31/08/2018

Other documents

Name Version Date
Hospital Anxiety and Depression Scale (HADS) – –

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.

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