Amendment 13
Documents in this amendment
You can download all of the files for this amendment in one go using the link below.
Download all amendment 13 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.
Download tracked changes amendment 13 files
Site file documents
* - these documents should be prepared on Trust-headed paper.
Section | Details | Version | Date |
---|---|---|---|
Section 1: Protocol | BADBIR Protocol | 20 | 01/08/2022 |
Section 2: PIL | Participants over 16 years of age: | ||
Patient Information Sheet* | 5.3 | 01/08/2022 | |
Patient Consent Form* | 5.3 | 01/08/2022 | |
Participants under 16 years of age: | |||
Children's Information Sheet | 2.2 | 01/08/2022 | |
Very Young Children's Information Sheet | 2.2 | 01/08/2022 | |
Young Person's Information Sheet | 2.2 | 01/08/2022 | |
Patient Assent Form* | 5.3 | 01/08/2022 | |
Participant Consent Form (parent or guardian)* | 5.3 | 01/08/2022 | |
Other Documents: | |||
Patient Portal Invitation Letter* | 1 | 01/08/2022 | |
Section 3: Regulatory and other essential documents | Amendment Tool for Substantial Amendment 13 (non-CTIMP) | 13 | 01/08/2022 |
HRA Approval | 13 | 19/01/2023 | |
REC Approval | 13 | 19/01/2023 |
Other documents
Name | Version | Date |
Clinical Baseline Questionnaire | 11 | 01/08/2022 |
Clinical Follow-Up Questionnaire | 11 | 01/08/2022 |
Patient Baseline Questionnaire | 6 | 01/08/2022 |
Patient Follow-Up Questionnaire | 7 | 01/08/2022 |
Under 16 Patient Baseline Questionnaire | 2 | 01/08/2022 |
- 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.