Amendment 14
Study Amendment 14 to BADBIR has an implementation date of 8th May 2025.
Documents in this amendment
You can download all of the files for this amendment in one go using the link below (.zip file).
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 (.zip).
Site file documents
* – these documents should be prepared on Trust-headed paper.
| Section | Details | Version | Date |
|---|---|---|---|
| Section 1: Protocol | BADBIR Protocol |
21 | 26/09/2024 |
| Section 2: PIL | Other Documents: | ||
| Patient Portal Invitation Letter |
2 | 26/09/2024 | |
| Section 3: Regulatory and other essential documents | Amendment Tool for Substantial Amendment 14 (non-CTIMP) | 14 | 26/09/2024 |
| HRA Approval | 14 | 26/09/2024 | |
| REC Approval | 14 | 26/09/2024 | |
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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