Procedures for research governance, sponsorship responsibilities, and regulatory compliance to uphold integrity and accountability. FA001 Facilitating a Regulated or Complex Project Document FA001 Facilitating a Regulated or Complex Project v7.0 (558.96 KB / PDF) Document FA001-T03 Facilitation Checklist v9.0 (86.55 KB / DOCX) Document FA001-T05 Regulatory Checks Complete Template Email v3.0 (62.95 KB / DOCX) Document FA001-T07 Global Health Facilitation Checklist v2.0 (98.5 KB / DOCX) GH001 Global Health Sponsorship Document GH001 Global Health Sponsorship v4.0 (927.33 KB / 0) Document GH001-T01 Global Health Non-CTIMP Protocol Template v2.0 (192.2 KB / 0 ) Document GH001-T02 Global Health Data Only Protocol Template v2.0 (178.83 KB / 0 ) Document GH001-T03 Global Health Qualitative Protocol Template v2.0 (189.23 KB / 0) Document GH001-T04 Global Health PIS v2.0 (174.71 KB / 0 ) Document GH001-T05 Global Health CF v2.0 (166.41 KB / 0) GH002 Global Health Sponsor Approval of Amendments Document GH002 Global Health Sponsor Approval of Amendments v3.0 (882.05 KB / 0) Document GH002-T01 Global Health Substantial Amendment Checklist v3.0 (163.66 KB / 0 ) GS001 R&D Governance Review of Non-Commercial Studies Document GS001 R&D Governance Review of Non-Commercial Studies v10.0 (954.06 KB / 0) Document GS001-F02 Governance Review Checklist v12.0 (6.72 MB / 0) Document GS001-F04 Service Support Costs v2.0 (88.5 KB / DOC) Document GS001-F05 Study Information Form v3.0 (175.27 KB / 0) Document GS001-W01 Regulated Study Agreement Preparation - Host v5.0 (164.39 KB / 0) GS002 Combined Risk Assessment Document GS002 Combined Risk Assessment v6.0 (494.02 KB / PDF) Document GS002-T01 Combined Risk Assessment Tool Report v9.0 (106.5 KB / DOCX) Document GS002-WI01 Essential Document Checklist v1.0 (182.5 KB / DOC) GS003 Sponsorship Approval Document GS003 Sponsorship Approval v11.0 (516.12 KB / PDF) Document GS003-F01 Sponsorship Checklist v6.0 (528.91 KB / PDF) Document GS003-F02 Country Level Feasibility Questionnaire v1.0 (64.42 KB / DOCX) Document GS003-T01 Sponsorship Review v1.0 (144.5 KB / DOC) Document GS003-T02 NHS Lothian Co-Sponsorship Criteria v1.0 (80.2 KB / DOCX) Document GS003-T03 Sponsorship Guidance v3.0 (226 KB / DOC) Document GS003-T04 Trial Support Responsibilities Record (43.38 KB / DOCX) GS005 Archiving Essential Study Documentation Document GS005 Archiving Essential Study Documentation v6.0 (908.5 KB / PDF) Document GS005-F01 Archive Information Form v7.0 (155.81 KB / 0) Document GS005-T01 Box Labels v1.0 (20.98 KB / DOCX) Document GS005-WI01 Archiving Guidance for Researchers v7.0 (160.06 KB / 0) GS006 Research Passports Document GS006 Research Passports v5.0 (767.01 KB / PDF) Document GS006-F01 Research Passport Checklist v3.0 (156.47 KB / DOCX) GS007 R&D Governance Review of Amendments Document GS007 R&D Governance Review of Amendments v6.0 (864.54 KB / PDF) Document GS007-F01 R&D Amendment Checklist v6.0 (73.9 KB / DOCX) Document GS007-WI01 R&D Receipt of Research Amendments v1.0 (88.33 KB / DOCX) Document GS007-WI02 R&D Processing of Research Amendments v1.0 (95.7 KB / DOCX) Document GS007-WI03 R&D Approval of Research Amendments v2.0 (162.86 KB / 0) GS008 Processing Personal Information - Caldicott Approval & Information Governance Review Document GS008 Processing Personal Information: Caldicott Approval & Information Governance Review v6.0 (900.94 KB / PDF) Document GS008-F01 Local Caldicott/Information Governance Form v4.0 (235.5 KB / 0) Document GS008-F02 Use of Portable Media Checklist v1.0 (141.5 KB / 0) GS009 Recruitment Figures Document GS009 Recruitment Figures v5.0 (554 KB / 0) GS010 Sponsor IMP Management Document GS010 Sponsor IMP Management v5.0 (908.45 KB / 0) Document GS010-T01 Rationale and Procedures for Site to Site Transfer of IMPs v2.0 (206.27 KB / DOCX) Document GS010-T02 Accountability Log Review Checklist v2.0 (156.9 KB / 0) Document GS010-T03 Prescription Review Checklist v2.0 (156.02 KB / 0) Document GS010-T04 Pharmacy Manual IMP Handling Instructions Review Checklist v2.0 (158.78 KB / 0) GS011 Sponsor Approval of Amendments Document GS011 Sponsor Approval of Amendments v8.0 (722.17 KB / PDF) Document GS011-T01 Substantial Amendment Checklist v6.0 (81.22 KB / DOCX) Document GS011-T02 Amendment Implementation Template Email v4.0 (30.15 KB / DOCX) Document GS011-T03 Amendment Classification and Authorisation Template Email v6.0 (40.01 KB / DOCX) Document GS011-T04 Amendment Log v1.0 (62.44 KB / DOCX) Document GS011-T05 Site-PI Amendment Classification and Implementation Template Email v3.0 (35.73 KB / DOCX) GS012 Advanced Therapy and Gene Modification Safety Committee Approval for Research Document GS012 Advanced Therapy and Gene Modification Safety Committee Approval for Research v6.0 (703.15 KB / 0) Document GS012-F01 ATMP Gene Modification Risk Assessment v5.0 (197.89 KB / 0 ) Document GS012-T01 NHSL Risk Assessment Report v2.0 (179.05 KB / 0 ) GS013 Site Feasibility Document GS013 Site Feasibility v3.0 (878 KB / 0) Document GS013-T01 Feasibility Questionnaire v4.0 (163.29 KB / 0) GS014 Sponsorship Approval for DataLoch Research Studies Document GS014 Sponsorship Approval for DataLoch Research Studies v2.0 (511.48 KB / PDF) Document GS014-F01 DataLoch Study Sponsorship Review v2.0 (93.88 KB / DOCX) Document GS014-WI01 Dataloch IG and Sponsorship Review Work Instruction v1.0 (84.74 KB / DOCX) GS015 R&D Governance Review of Commercial Studies Document GS015 R&D Review of Commercial Studies v2.0 (951.74 KB / 0) Document GS015-F01 Commercial Governance Review Checklist v3.0 (5.06 MB / 0) Document GS015-F02 Study Information Form v1.0 (171.63 KB / 0) This article was published on 2024-11-07
