Amendment 10
Documents in this amendment
You can download all 14 of the files for this amendment in one go using the link below.
Download all amendment 10 files
Site file documents
* - these documents should be prepared on Trust-headed paper.
| Section | Details | Version | Date |
|---|---|---|---|
| Section 1: Protocol | BADBIR Protocol | 17 | 01/09/2017 |
| Section 2: PIL | Participants over 16 years of age: | ||
| Patient Information Sheet* (Word version) | 5 | 01/08/2017 | |
| Patient Consent Form* (Word version) | 5 | 01/08/2017 | |
| Participants under 16 years of age: | |||
| Patient Assent Form* (Word version) | 5 | 01/08/2017 | |
| Participant Consent Form (parent or guardian)* (Word version) | 5 | 01/08/2017 | |
| Participant Information Sheet (for children)* | 2 | 01/08/2017 | |
| Participant Information Sheet (for young children)* | 2 | 01/08/2017 | |
| Participant Information Sheet (for very young children)* | 2 | 01/08/2017 | |
| Section 3: Regulatory and other essential documents | Notice of Substantial Amendment (non-CTIMP) and Favourable Approval Letter* | 10 | 11/09/2017 |
| HRA IRAS Confirmation of Amendment Assessment | 11/09/2017 | ||
Other documents
| Name | Version | Date |
| Conditional Approval to Access Hospital Episode Statistics Data | 24/03/2016 | |
| Clinical Baseline Questionnaire | 9 | 01/08/2017 |
| Clinical Follow-up Questionnaire | 9 | 01/08/2017 |