IcICLLe Amendments

• Summary of Amendments  [.pdf]

Please note that not all substantial amendments are notifiable to sites - please refer to the Summary of Amendments documents which states which amendment documentation you need in the ISF.

• IcICLLe Protocol v7.0_05-Sep-2016 [.pdf]
• IcICLLe Protocol v7.0_05-Sep-2016_TC from v6.0 [.pdf]
• IcICLLe PIS-ICF v8.0a_07-Nov-2016 [.docx]
• IcICLLe PIS-ICF v8.0a_07-Nov-2016_TC from v7.0 [.docx]
• IcICLLe PIS-ICF Addendum B(i) to v5.0_08-Nov-2016 [.docx]
• IcICLLe GP letter v6.0a_07-Nov-2016 [.docx]
• IcICLLe GP letter v6.0a_07-Nov-2016_TC from v5.0 [.docx]
• Notice of Substantial Amendment SA08 [.pdf]
• MHRA approval_29-Nov-2016 [.pdf]
• REC approval_25-Sep-2016 [.pdf]
• HRA Categorisation_25-Oct-2016 [.pdf]
• HRA approval_02-Dec-2016 [.pdf]

NB - Substantial Amendment 7.0 was a regulatory submission and approval for this is not needed at Sites.

PI protocol signature sheets:

• Belfast City Hospital
• University Hospital of Wales, Cardiff
• Hammersmith Hospital
• Kings College Hospital
• The Royal Liverpool
• Nottingham City Hospital
• QEH Birmingham
• SJUH Leeds
• The Christie

• IcICLLe Protocol v6.0_19-Aug-2015 [.pdf]
• IcICLLe Protocol v6.0_19-Aug-2015_TC from v4.0 [.docx] 
• IcICLLe Study Synopsis v6.0b_10-Nov-2015
• IcICLLe PIS-ICF v7.0_19-Aug-2016 [.docx]
• IcICLLe PIS-ICF v7.0_19-Aug-2016_TC from v6.0a [.docx]
• IcICLLe PIS and Consent Form Addendum A to vn5.0_09-Jun-2015 [.docx]
• IcICLLe GP letter v5.0_19-Aug-2015 [.docx]
• IcICLLe GP letter v5.0_19-Aug-2015_TC from v4.0 [.docx]
• Ibrutinib SPC_28-Oct-2014
• Obinutuzumab SPC_23-Jul-2014
• Notice of Substantial Amendment SA06 [.pdf] 
• MHRA products form [.pdf] 
• MHRA approval_SA 06_22-Oct-2015 [.pdf] 
• REC approval_SA 06_25-Sep-2015 [.pdf] 
• REC approval_SA 05_23-Jul-2016 [.pdf] (REC approval for addendum A to PIS-ICF v5.0)

The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Amendment 4.0_23-May-2014   [.zip] - protocol v4.0
• Amendment 3.0_14-Mar-2014 - addition of trial site only
• Amendment 2.0_10-Apr-2014  - addition of trial site only
• Amendment 1.0_11-Mar-2014  - protocol v3.0 

No non-substantial amendments have been made to the IcICLLe trial as yet.