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HSC R&D Manager Contact Details (9 KB)

2015-16 Compliance Statement pdf (135 KB)

PICS leaflet (1,001 KB)

NHSCT 17-18 Meeting dates (31 KB)

WHSCT RGC Meetings 2017 pdf (61 KB)

Informed Consent April 2017 Flyer (29 KB)

BHSCT 1718 Meeting Dates (35 KB)

HTA Licensing Structure 2017 (221 KB)

QUB-ADRE-001 Creation, Control, Amendment v 6.0 (240 KB)

QUB-ADRE-002 Development, Review & Amendment v 5.0 (517 KB)

QUB-ADRE-004 Informed Consent for Research v 8.0 (504 KB)

QUB-ADRE-005 Delegation of Responsibilities v 5.0 (257 KB)

QUB-ADRE-006 Reporting and Managing Research Related Adverse Events v 5.0 (281 KB)

QUB-ADRE-007 Preparation, Completion, Signing and Correcting Case Report Forms v (159 KB)

QUB-ADRE-008 CTIMPS Files v 5.0 (417 KB)

QUB-ADRE-009 Education, Training and Experience v 5.0 (107 KB)

QUB-ADRE-010 Application to MHRA for Clinical Trials Authorisation v 5.0 (137 KB)

QUB-ADRE-011 Amendments to Protocols and Essential Documentation v 5.0 (196 KB)

QUB-ADRE-012 End of Study Declaration v 5.0 (99 KB)

QUB-ADRE-003 The Ethical Approval of Research v 6.0 (176 KB)

Community-University Research Guidelines (89 KB)

Consent Form Template (104 KB)

Audit of Labs to GCP Standards (433 KB)

Receipt, Labelling, Tracking and Storage of Human Tissue (363 KB)

Disposal of Human Tissue (261 KB)

Internal Audit of HTA Licenced Premises (398 KB)

Recording HTA related Adverse events (180 KB)

Assessment of Risk to Personnel for the Handling of Human Tissue (475 KB)

Assessment of Risk to Human Tissue (306 KB)

External Transfer and Export of Relevant Material (175 KB)

Import of Relevant Material (173 KB)

Transportation of Human Tissue (376 KB)

Informed Consent for Research (518 KB)

HTA Adverse Events Form v 2.0 (40 KB)

HTA Adverse Event Notification Form (40 KB)

Request for External Transfer or Export of Human Tissue Form (112 KB)

Authority to Import Form (111 KB)

Research File Content Checklist (17 KB)

Disposal Form Template (57 KB)

Guidelines for Research Files (178 KB)

Withdrawal of Consent (147 KB)

SOP 13 Production of Progress, Safety and Final Reports 30.03.17 (154 KB)

SOP 14 Clinical Investigations of Medical Devices 30.03.2017 (559 KB)

SOP 15 Indemnity and Sponsorship of research studies 30.03.17 (172 KB)

SOP 16 Good Clinical Practice - Inspections 30.03.17 (176 KB)

SOP 17 data Management - Collection, Validation and Storage 30.03.17 (187 KB)

SOP 18 Research Governance Audit 30.03.17 (547 KB)

SOP 19 Matters of Non-Compliance with Study Protocol 30.03.17 (246 KB)

SOP 20 Termination or Suspension of a Research Study 30.03.17 (130 KB)

SOP 21 Risk Assessment of Research Studies 30.03.17 (262 KB)

SOP 22 Publication and Dissemination of Study Outcomes 30.03.17 (202 KB)

SOP 23 Monitoring of Clinical Trials of Investigational Medicinal Products 2017 (176 KB)

SOP 24 Complaints from Research Participants 30.03.17 (170 KB)

SOP 25 Maintaining Laboratory Book 30.03.17 (124 KB)

SOP 26 Breach of Patient Confidentiality in IMP Studies 30.03.17 (105 KB)

SOP 27 Archiving Research Study Documents 30.03.17 (128 KB)

SOP 28 Contracting Procedure for CTIMPS 30.03.17 (157 KB)

Research File Content Checklist (17 KB)

BHSCT RGC 2017 meeting dates pdf (38 KB)

NHSCT RGC 2017 (17 KB)

SHSCT RGC 2017 (32 KB)

AWERB Annual Report 2015-16 (48 KB)

QUB-HTA-010 Withdrawal of Consent Human Tissue April 2017 (70 KB)

QUB-HTA-009 Transportation of Human Tissue April 2017 (86 KB)

QUB-HTA-008 Import of Relevant Material April 2017 (71 KB)

QUB-HTA-007 External Transfer and Export of Relevant Material (71 KB)

QUB-HTA-006 Assessment of Risk to Human Tissue April 2017 (86 KB)

QUB-HTA-005 Assessment of Risk to Personnel for the handling of HT April 2017 (127 KB)

QUB-HTA-004 Recording HTA Related Adverse Events April 2017 (82 KB)

QUB-HTA-003 Internal Audit of HTA Licensed premises, Facilities and Equipment Ap (105 KB)

QUB-HTA-002 Disposal of Human Tissue April 2017 (94 KB)

QUB-HTA-001 Receipt, Labelling, Tracking and Storage of HT April 2017 (223 KB)

QUB-ADRE-011 Amendments to Protocols and Essential Documentation v 5.0.unsignpdf (65 KB)

QUB-ADRE-010 Application to MHRA for CT Authorisation unsigned v 5.0 (60 KB)

QUB-ADRE-026 Breach of Patient Confidentiality in IMP Studies unsigned (41 KB)

QUB-ADRE-014 Clinical Investigations of Medical Devices unsigned (396 KB)

QUB-ADRE-024 Complaints from Research Participants unsigned (58 KB)

QUB-ADRE-028 Contracting Procedure for CTIMPS unsigned (76 KB)

QUB-ADRE-017 Data Management Collection, Validation & Storage unsigned (61 KB)

QUB-ADRE-005 Delegation of Responsibilities v 5.0 unsigned (105 KB)

QUB-ADRE-002 Development Review and Amendment v 5.0 unsigned (124 KB)

QUB-ADRE-009 Education, Training and Experience v 5.0 unsigned (48 KB)

QUB-ADRE-012 End of Study Declaration v 5.0 unsigned (47 KB)

QUB-ADRE-012 End of Study Declaration v 5.0 unsigned (47 KB)

QUB-ADRE-016 GCP Inspections unsigned (69 KB)

QUB-ADRE-015 Indemnity and Sponsorship of research studies unsigned (59 KB)

QUB-ADRE-025 Maintaining Lab Books unsigned (47 KB)

QUB-ADRE-019 Matters of non-compliance with study protocol unsigned (77 KB)

QUB-ADRE-023 Monitoring of CTIMPS unsigned (59 KB)

QUB-ADRE-007 Preparation, Completion, Signing and Correcting Case Report Forms U (57 KB)

QUB-ADRE-013 Production of Progress, Safety and Final Reports unsigned (50 KB)

QUB-ADRE-022 Publication & Dissemination of Study Outcomes unsigned (64 KB)

QUB-ADRE-006 Reporting & managing Research Related AE's unsigned (83 KB)

QUB-ADRE-018 RG Audit (151 KB)

QUB-ADRE-021 Risk Assessment of Research Studies unsigned (86 KB)

QUB-ADRE-008 CTIMPS Files v 5.0 unsigned (95 KB)

QUB-ADRE-020 Termination or Suspension of Research study unsigned (51 KB)

QUB-ADRE-003 The Ethical Approval of Research v 6.0 unsigned (54 KB)

HTA 3 2019 review (105 KB)

HTA 5 2019 review (127 KB)

HTA 7 2019 review (71 KB)

HTA 9 2019 review (86 KB)

QUB-ADRE-027 Archiving Research Study Documents unsigned (94 KB)

QUB-ADRE-001 Creation Control Amendment v 6.0 unsigned (94 KB)

QUB-ADRE-021 Risk Assessment of Research Studies unsigned (83 KB)

Informed Consent for Research unsigned v 4.0 (129 KB)

QUB-ADRE-010 Application to MHRA for Clinical Trials Authorisation unsigned (54 KB)

Professional Bodies (16 KB)

EPS Proportionate Review Application Form (New Brand) (274 KB)

EPS Full Ethical Approval Form (New Brand) (280 KB)

EPS Confirmation of Existing Ethical Approval Form (New Brand) (272 KB)

Annual Progress Report Form (30 KB)

Notification of Amendment Form September 2019 (34 KB)

Notification of End of Study Form (30 KB)

HTA Training 2017-18 (16 KB)

SHSCT 2018 Meetings.pdf (34 KB)

Frequently Asked Questions (240 KB)

Proportionate Review Application - Question Specific Guidance (217 KB)

Full Ethical Approval Form - Question Specific Guidance (282 KB)

Faculty REC Application Workstreams - revised Nov 2017 (162 KB)

Proportionate Review Screening Tool v2 (375 KB)

SEHSCT RG Dates 2018 (16 KB)

Northern HSC Trust RG Committee Dates 2018 (11 KB)

2016-17 Compliance Statement (225 KB)

HTA Training Schedule Summer 2017/18 (12 KB)

Trust RG Guide for Applicants - June 2018 (452 KB)

BHSCT RGC 2018 dates (50 KB)

WHSCT RGC 2018 dates (52 KB)

NHSCT RGC 2018 dates (47 KB)

SEHSCT RGC 2018 dates (52 KB)

SHSCT RGC 2018 dates (53 KB)

Faculty REC Meeting Dates 2018-19 (206 KB)

Regulations Governing Allegation & Investigation of MiR - Senate June 2018 (120 KB)

EPS Faculty REC - FAQ (638 KB)

HTA Training Schedule 2018/19 (17 KB)

BHSCT RGC 2018 dates updated (50 KB)

Common Pitfalls for Applicants and How to Avoid Them (143 KB)

SUMMARY OF PROCESS TO APPLY FOR NHS REC & HSC R&D APPROVAL (179 KB)

HTA Training Schedule Summer 2018/19 Update 1 (17 KB)

QUB Policy on Fieldwork in Conflict Zones (153 KB)

BHSCT RGC 2018 dates further update (51 KB)

NHSCT RG Committee Dates 2019 (50 KB)

SHSCT RG Committee Dates 2019 (50 KB)

WHSCT RG Committee Dates 2019 (59 KB)

HTA Summer Schedule 2018-19 (17 KB)

Policy on the Ethical Approval of Research January 2019 (94 KB)

Annual Statement on Compliance 2017-18 (193 KB)

HTA Training Schedule 2018-19 (Revised) (207 KB)

BHSCT RG Meeting dates 2019 Updated (51 KB)

Application Summary Flowchart (51 KB)

Misconduct in Research Regulations _SENATE APPROVED May 2019 (130 KB)

Informed Consent for Research v10.0 (141 KB)

Research Governance Audit v 7.0 (171 KB)

Complaints from Research Participants v 6.0 (69 KB)

HTA SOP Import of Relevant Material V4 May 2019 (66 KB)

HTA SOP Withdrawal of Consent - Human Tissue V3 May 2019 (70 KB)

HTA SOP Transportation of Human Tissue V4 May 2019 (92 KB)

HTA SOP External Transfer and Export of Relevant Material V4 May 2019 (96 KB)

HTA SOP Assessment of Risk to Human Tissue V4 May 2019 (92 KB)

HTA SOP Assessment of Risk to Personnel for the Handling of HT V4 May 2019 (131 KB)

HTA SOP Recording Human Tissue Act Related Adverse Events V4 May 2019 (83 KB)

HTA SOP Internal Audit of HTA Licensed Premises V6 May 2019 (111 KB)

HTA SOP Disposal of Human Tissue V6 May 2019 (100 KB)

HTA SOP Receipt, Labelling, Tracking and Storage of Human Tissue V5 May 2019 (230 KB)

HTA Training Schedule 2019-2020 (16 KB)

Policy on the Ethical Approval of Research Jan 2019 (94 KB)

Gov 2 form Aug 2019 (59 KB)

FREC Flowchat No Risk FINAL (44 KB)

QUB Summary Sponsor flowchart v5.0 (174 KB)

Gov 4 Aug 2019 (884 KB)

HTA Licensing Structure Aug 2019 (98 KB)

HTA Quality Manual v6.0 Apr 2019 (252 KB)

EPS Faculty REC Meeting Schedule 19/20 (13 KB)

SEHSCT Committee dates Aug 2019 (52 KB)

MHLS FREC Proportionate Review Ethics Application (276 KB)

MHLS Full Review Ethics Application (283 KB)

MHLS Confirmation of Existing Ethical Approval Form (268 KB)

MHLS Faculty REC Meeting Schedule 2022 2023 (13 KB)

Faculty REC Application Process flowchart v4 27.08.19 (52 KB)

EPS Screening Tool 06.09.2019 v3 (78 KB)

MHLS Screening Tool 06.09.2019 v1 (87 KB)

FREC PIS Consent Form Template Guidance (18 KB)

FREC PIS Template (79 KB)

FREC Consent Form Template (104 KB)

Gov1 (53 KB)

Peer Review Gov4 (884 KB)

Animal Procedures per annum up to 2017 (476 KB)

Schedule 1 2013 - 2017 (322 KB)

BHSCT RG Meeting dates 2020 (365 KB)

Compliance statement for 2018-19 (234 KB)

EPS Animal Welfare Ethics Application (273 KB)

MHLS Animal Welfare Ethics Application (267 KB)

NHSCT RG Meeting dates 2020 (362 KB)

SEHSCT RG meeting dates 2020 (52 KB)

SHSCT RG Meeting dates 2020 (362 KB)

WHSCT RG Meeting dates 2020 (396 KB)

SEHSCT RG meeting dates 2020 - Update (384 KB)

HSC R&D Manager Details updated 19_07_16 (9 KB)

HSC R&D Manager Details updated 13_01_2020 (11 KB)

HTA Adverse Events Form v 4.0 (74 KB)

External Transfer or Export of Human Tissue v3.0 (841 KB)

Import Form v3.0 (844 KB)

Consent Form Template (105 KB)

the-concordat-to-support-research-integrity 2019 (371 KB)

Terms of Reference and Membership for RGEIC Sept 2019 (24 KB)

Covid-19 FAQ's (99 KB)

Final approved Conflict Zone Policy_Updated 2020 (496 KB)

Principles for Human Participant Research during COVID-19 Pandemic (307 KB)

EPS FREC 22/23 Meeting Schedule (13 KB)

HTA Schedule 2020-2021 (116 KB)

HTA updated schedule 20-21 (116 KB)

HTA Training schedule 20-21 updated 2 (115 KB)

Regulations for Research Involving Human Participants 2020 (325 KB)

Policy on the Ethical Approval of Research September 2020 (287 KB)

HTA Schedule 2021 Update 2 (290 KB)

Complaince statement for 2019-20 approved (236 KB)

HTA Schedule 2021/22 (290 KB)

Creation, Control, Amendment and Storage of SOPs for Res Gov (290 KB)

SOP 002 Development and Review Research Protocol_Plan (339 KB)

SOP 003 The Ethical Approval of Research (169 KB)

SOP 004 Informed Consent for Research (446 KB)

SOP 005 Delegation of Responsibilities (693 KB)

SOP 006 Reporting and Managing Research Related Adverse Events (173 KB)

SOP 007 Preparation, Completion, Signing and Correcting Case Report Forms (257 KB)

SOP 008 Setting Up, Maintaining and Archiving Research Files (311 KB)

SOP 009 Education Training and Experience v1.0 FINAL (297 KB)

SOP 010 Amendments to Study Documentation (344 KB)

SOP 011 End of Study Declaration, Early Termination & Final Report (187 KB)

SOP 012 Production of Progress Reports (235 KB)

SOP 013 Indemnity and Sponsorship of Research Studies (1,157 KB)

SOP 014 Data Management_Collection Validation and Storage (250 KB)

SOP 015 Research Governance Audit (355 KB)

SOP 016 Matters of Non-compliance with Study Protocol (260 KB)

Compliance Statement for 2020-21 (59 KB)

ATAS FAQ's (538 KB)

Resources - Safeguarding in research (408 KB)

Resources for Trusted Research (519 KB)

QUB HTA-001 v6.0 Receipt, Labelling, Tracking and Storage of Human Tissue (349 KB)

QUB-HTA-002 v6.0 Disposal of human tissue (475 KB)

QUB-HTA-003 v7.0 Internal Audit of HTA Licensed Premises (422 KB)

QUB-HTA-004 v5.0 Recording Human Tissue Act Related Adverse Events (199 KB)

QUB-HTA-005 v5.0 Assessment of Risk to Personnel (303 KB)

QUB-HTA-006 v 5.0 Assessment of Risk to Tissue (214 KB)

QUB-HTA-007 v5.0 Transfer and Export of Relevant Material (192 KB)

QUB-HTA-008 v5.0 Import of Relevant Material (186 KB)

QUB-HTA-009 v5.0 Transportation of Human Tissue (294 KB)

QUB-HTA-010 v4.0 Withdrawal of Consent - Human Tissue (257 KB)

HTA Quality Manual v7.0 November 2021 (487 KB)

SOP 017 Risk Assessment of Research Studies (192 KB)

SOP 018 Monitoring of Research Studies (267 KB)

SOP 019 Complaints from Research Participants (272 KB)

SOP 020 Maintaining Laboratory Books (241 KB)

SOP 021 Breach of Participant Confidentiality (148 KB)

SOP 022 Clinical Trial Sample Analysis in University Laboratories (483 KB)

BHSCT - RGC DATES 2022 (451 KB)

NHSCT - RGC DATES 2022 (453 KB)

SHSCT - RGC DATES 2022 (461 KB)

TBC for 2022 (180 KB)

QUB Summary Sponsor LIP v8.0 (59 KB)

Export Control - Resources (83 KB)

Export Control Policy (552 KB)

Proposed HTA Training Schedule 2022-2023 (121 KB)

Proposed HTA Training Schedule 2022-2023 update (121 KB)

Resources for Trusted Research - Updated (545 KB)

Resources for Trusted Research - 24-06-22 (547 KB)

Table 1 Animal procedures per annum 2022 (488 KB)

HTA Training Schedule 2022-2023 - Final (119 KB)

Misconduct in Research Regulations_Final October 2021 (120 KB)

HTA Quality Manual v7.0 November 2021 (486 KB)

Authority to Import Form (83 KB)

Disposal Form Template (57 KB)

HTA Adverse Events Form v5.0 (72 KB)

Request for External Transfer or Export of Human Tissue (83 KB)

Preventing Harm in Research & Innovation (1,123 KB)

Resources (68 KB)

NSI Act - Resources (58 KB)

Informed Consent for Research (158 KB)

Sponsor Green Light (146 KB)

Registration of Clinical Trials (54 KB)

Convening of Trial Steering Committees and Data Monitoring Committees (53 KB)

Contracting for CTIMPs (58 KB)