CLARITY Amendments

Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Protocol v3.0_20-May-2016 [.pdf]
• Patient Information Sheet v4.0_20-May-2016 [.docx]
• Patient Information Sheet v4.0_20-May-2016 [.pdf]
• Notice of Substantial Amendment_03_20-May-2016 [.pdf]
• REC Cover Letter for SA03_24-May-2016 [.pdf]
• REC Approval for SA03_07-Jun-2016 [.pdf]
• MHRA Cover Letter for SA03_24-May-2016 [.pdf]
• MHRA Approval for SA03_23-Jun-2016 [.pdf]
• HRA Confirmation of amendment categorisation SA03_05-Jul-2016 [.pdf]
• HRA Confirmation of amendment assessment SA03_12-Jul-2016 [.pdf]

Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents:

• Patient diary weeks 1-8 v1.0_07-Mar-2016 [.pdf]
• Patient diary weeks 9-15 v1.0_07-Mar-2016 [.pdf]
• Patient diary months 4-26 v1.0_07-Mar-2016 [.pdf]
• Notice of Substantial Amendment_02_20-Apr-2016 [.pdf]
• REC Cover Letter for SA02_29-Apr-2016 [.pdf]
• REC Approval for SA02_09-May-2016 [.pdf]
• HRA Confirmation of amendment categorisation SA02_05-Jul-2016 [.pdf]
• HRA Confirmation of amendment assessment SA02_11-Jul-2016 [.pdf]

• Summary of Amendments [.pdf]
• Substantial Amendment 1.0 - amended documents submitted to gain initial approval from REC

Non-Substantial Amendment 01

• Notification of non-substantial amendent 10-Aug-2016 [.pdf]
• CLARITY Protocol v3.0a_10-Aug-2016 (clean) [.pdf]
• CLARITY Protocol v3.0a_10-Aug-2016 (tracked changes) [.pdf]
• CLARITY Patient Information Sheet [.docx]
• HRA Categorisation of NSA01_26-Aug-2016 [.pdf]