Regulatory - Substantial Amendment 01 In 'participating sites' Participating HospitalsCase Report FormsStudy Documents Back to 'Tessa Jowell BRAIN MATRIX' Substantial Amendment 01 Regulatory Approval Documents for the BRAIN MATRIX Study: Please ensure that you have obtained local R&D approval for this amendment before using these documents. All documents require a username and password to login to access - please contact the BRAIN MATRIX Study Office if you require these. HRA IRAS 269228_HRA Amendment Tool SA-01 08-Dec-2020 [PDF, 377 KB] IRAS 269228_HRA & HCRW Approval SA-01 24-Dec-2020 [PDF, 115 KB] REC TJBM REC SA-01 Submission Cover Letter 08-Dec-2020 [PDF, 126 KB] IRAS 269228_19WM0369_SA-01 Amendment Valid 09-Dec-2020 [PDF, 18 KB] IRAS 269228_19WM0369_SA-01 Favourable Opinion 24-Dec-2020 [PDF, 112 KB] Study Documents Study Protocol [PDF, 1,461 KB] Patient Information Sheet [Word, 897 KB] Informed Consent Form [Word, 176 KB] Quality of Life Booklet [PDF, 150 KB] Please note: The PIS and ICF should be localised using hospital headed paper.