Amendment 8

Study Amendment 8 to BADBIR was approved on 28/09/2015.

Documents in this amendment

You can download all 16 files for this amendment in one go using the button below.

Download all amendment 8 files

Site file documents

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

Section Details Version Date
Section 1: Protocol Protocol 15 01/07/2015
Section 2: PIL
Participants under 16 years of age:
Patient Assent Form* 4 14/05/2009
Participant Consent Form (parent or guardian)* 4 14/05/2009
Participant Information Sheet (for children)* 1 01/07/2015
Participant Information Sheet (for young children)* 1 01/07/2015
Participant Information Sheet (for very young children)* 1 01/07/2015
Section 3: Regulatory and other essential documents Notice of Substantial Amendment and Favourable Approval Letter* 8 28/09/2015

Other documents

Name Version Details
Clinical Follow-up Questionnaire 8
CDLQI Children's Dermatology Life Quality Index
CDLQI cartoon version Children's Dermatology Life Quality Index for younger children
EQ-5D-Y Children's EQ-5D (EuroQol)
CHAQ Childhood Health Assessment Questionnaire (applicable if the patient has a diagnosis of Inflammatory Arthritis)
System-level security policy This documents outlines the security of BADBIR data
Conventional cohort switches to biologic A graph detailing the trend of patients switching cohorts