Amendment 12
Documents in this amendment
You can download all of the files for this amendment in one go using the link below.
Download all amendment 12 files
Site file documents
* - these documents should be prepared on Trust-headed paper.
Section | Details | Version | Date |
---|---|---|---|
Section 1: Protocol | BADBIR Protocol | 19 | 01/06/2020 |
Section 2: PIL | Participants over 16 years of age: | ||
Patient Information Sheet* | 5.2 | 01/06/2020 | |
Patient Consent Form* | 5.2 | 01/06/2020 | |
Participants under 16 years of age: | |||
Patient Assent Form* | 5.2 | 01/06/2020 | |
Participant Consent Form (parent or guardian)* | 5.2 | 01/06/2020 | |
Other Documents: | |||
Patient Invitation Letter* | 2 | 01/06/2020 | |
Patient Poster | 2 | 01/06/2020 | |
Section 3: Regulatory and other essential documents | Amendment Tool for Substantial Amendment 12(non-CTIMP) | 12 | 01/07/2020 |
HRA Approval | 12 | 26/08/2020 | |
REC Approval | 12 | 26/08/2020 |
Other documents
Name | Version | Date |
Clinical Baseline Questionnaire | 10 | 01/06/2020 |
Clinical Follow-Up Questionnaire | 10 | 01/06/2020 |
System Level Security Policy (SLSP) | v3 | 10/12/2018 |
Zip File of Tracked Changes Documentation
- Please be aware that occasionally 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.