Amendment 8
Documents in this amendment
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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 |