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Policies, procedures and guidelines
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HSC R&D Manager Contact Details
2015-16 Compliance Statement pdf
PICS leaflet
NHSCT 17-18 Meeting dates
WHSCT RGC Meetings 2017 pdf
Informed Consent April 2017 Flyer
BHSCT 1718 Meeting Dates
HTA Licensing Structure 2017
QUB-ADRE-001 Creation, Control, Amendment v 6.0
QUB-ADRE-002 Development, Review & Amendment v 5.0
QUB-ADRE-004 Informed Consent for Research v 8.0
QUB-ADRE-005 Delegation of Responsibilities v 5.0
QUB-ADRE-006 Reporting and Managing Research Related Adverse Events v 5.0
QUB-ADRE-007 Preparation, Completion, Signing and Correcting Case Report Forms v
QUB-ADRE-008 CTIMPS Files v 5.0
QUB-ADRE-009 Education, Training and Experience v 5.0
QUB-ADRE-010 Application to MHRA for Clinical Trials Authorisation v 5.0
QUB-ADRE-011 Amendments to Protocols and Essential Documentation v 5.0
QUB-ADRE-012 End of Study Declaration v 5.0
QUB-ADRE-003 The Ethical Approval of Research v 6.0
Community-University Research Guidelines
Consent Form Template
Audit of Labs to GCP Standards
Receipt, Labelling, Tracking and Storage of Human Tissue
Disposal of Human Tissue
Internal Audit of HTA Licenced Premises
Recording HTA related Adverse events
Assessment of Risk to Personnel for the Handling of Human Tissue
Assessment of Risk to Human Tissue
External Transfer and Export of Relevant Material
Import of Relevant Material
Transportation of Human Tissue
Informed Consent for Research
HTA Adverse Events Form v 2.0
HTA Adverse Event Notification Form
Request for External Transfer or Export of Human Tissue Form
Authority to Import Form
Research File Content Checklist
Disposal Form Template
Guidelines for Research Files
Withdrawal of Consent
SOP 13 Production of Progress, Safety and Final Reports 30.03.17
SOP 14 Clinical Investigations of Medical Devices 30.03.2017
SOP 15 Indemnity and Sponsorship of research studies 30.03.17
SOP 16 Good Clinical Practice - Inspections 30.03.17
SOP 17 data Management - Collection, Validation and Storage 30.03.17
SOP 18 Research Governance Audit 30.03.17
SOP 19 Matters of Non-Compliance with Study Protocol 30.03.17
SOP 20 Termination or Suspension of a Research Study 30.03.17
SOP 21 Risk Assessment of Research Studies 30.03.17
SOP 22 Publication and Dissemination of Study Outcomes 30.03.17
SOP 23 Monitoring of Clinical Trials of Investigational Medicinal Products 2017
SOP 24 Complaints from Research Participants 30.03.17
SOP 25 Maintaining Laboratory Book 30.03.17
SOP 26 Breach of Patient Confidentiality in IMP Studies 30.03.17
SOP 27 Archiving Research Study Documents 30.03.17
SOP 28 Contracting Procedure for CTIMPS 30.03.17
Research File Content Checklist
BHSCT RGC 2017 meeting dates pdf
NHSCT RGC 2017
SHSCT RGC 2017
AWERB Annual Report 2015-16
QUB-HTA-010 Withdrawal of Consent Human Tissue April 2017
QUB-HTA-009 Transportation of Human Tissue April 2017
QUB-HTA-008 Import of Relevant Material April 2017
QUB-HTA-007 External Transfer and Export of Relevant Material
QUB-HTA-006 Assessment of Risk to Human Tissue April 2017
QUB-HTA-005 Assessment of Risk to Personnel for the handling of HT April 2017
QUB-HTA-004 Recording HTA Related Adverse Events April 2017
QUB-HTA-003 Internal Audit of HTA Licensed premises, Facilities and Equipment Ap
QUB-HTA-002 Disposal of Human Tissue April 2017
QUB-HTA-001 Receipt, Labelling, Tracking and Storage of HT April 2017
QUB-ADRE-011 Amendments to Protocols and Essential Documentation v 5.0.unsignpdf
QUB-ADRE-010 Application to MHRA for CT Authorisation unsigned v 5.0
QUB-ADRE-026 Breach of Patient Confidentiality in IMP Studies unsigned
QUB-ADRE-014 Clinical Investigations of Medical Devices unsigned
QUB-ADRE-024 Complaints from Research Participants unsigned
QUB-ADRE-028 Contracting Procedure for CTIMPS unsigned
QUB-ADRE-017 Data Management Collection, Validation & Storage unsigned
QUB-ADRE-005 Delegation of Responsibilities v 5.0 unsigned
QUB-ADRE-002 Development Review and Amendment v 5.0 unsigned
QUB-ADRE-009 Education, Training and Experience v 5.0 unsigned
QUB-ADRE-012 End of Study Declaration v 5.0 unsigned
QUB-ADRE-012 End of Study Declaration v 5.0 unsigned
QUB-ADRE-016 GCP Inspections unsigned
QUB-ADRE-015 Indemnity and Sponsorship of research studies unsigned
QUB-ADRE-025 Maintaining Lab Books unsigned
QUB-ADRE-019 Matters of non-compliance with study protocol unsigned
QUB-ADRE-023 Monitoring of CTIMPS unsigned
QUB-ADRE-007 Preparation, Completion, Signing and Correcting Case Report Forms U
QUB-ADRE-013 Production of Progress, Safety and Final Reports unsigned
QUB-ADRE-022 Publication & Dissemination of Study Outcomes unsigned
QUB-ADRE-006 Reporting & managing Research Related AE's unsigned
QUB-ADRE-018 RG Audit
QUB-ADRE-021 Risk Assessment of Research Studies unsigned
QUB-ADRE-008 CTIMPS Files v 5.0 unsigned
QUB-ADRE-020 Termination or Suspension of Research study unsigned
QUB-ADRE-003 The Ethical Approval of Research v 6.0 unsigned
HTA 3 2019 review
HTA 5 2019 review
HTA 7 2019 review
HTA 9 2019 review
QUB-ADRE-027 Archiving Research Study Documents unsigned
QUB-ADRE-001 Creation Control Amendment v 6.0 unsigned
QUB-ADRE-021 Risk Assessment of Research Studies unsigned
Informed Consent for Research unsigned v 4.0
QUB-ADRE-010 Application to MHRA for Clinical Trials Authorisation unsigned
Professional Bodies
EPS Proportionate Review Application Form (New Brand)
EPS Full Ethical Approval Form (New Brand)
EPS Confirmation of Existing Ethical Approval Form (New Brand)
Annual Progress Report Form
Notification of Amendment Form September 2019
Notification of End of Study Form
HTA Training 2017-18
SHSCT 2018 Meetings.pdf
Frequently Asked Questions
Proportionate Review Application - Question Specific Guidance
Full Ethical Approval Form - Question Specific Guidance
Faculty REC Application Workstreams - revised Nov 2017
Proportionate Review Screening Tool v2
SEHSCT RG Dates 2018
Northern HSC Trust RG Committee Dates 2018
2016-17 Compliance Statement
HTA Training Schedule Summer 2017/18
Trust RG Guide for Applicants - June 2018
BHSCT RGC 2018 dates
WHSCT RGC 2018 dates
NHSCT RGC 2018 dates
SEHSCT RGC 2018 dates
SHSCT RGC 2018 dates
Faculty REC Meeting Dates 2018-19
Regulations Governing Allegation & Investigation of MiR - Senate June 2018
EPS Faculty REC - FAQ
HTA Training Schedule 2018/19
BHSCT RGC 2018 dates updated
Common Pitfalls for Applicants and How to Avoid Them
SUMMARY OF PROCESS TO APPLY FOR NHS REC & HSC R&D APPROVAL
HTA Training Schedule Summer 2018/19 Update 1
QUB Policy on Fieldwork in Conflict Zones
BHSCT RGC 2018 dates further update
NHSCT RG Committee Dates 2019
SHSCT RG Committee Dates 2019
WHSCT RG Committee Dates 2019
HTA Summer Schedule 2018-19
Policy on the Ethical Approval of Research January 2019
Annual Statement on Compliance 2017-18
HTA Training Schedule 2018-19 (Revised)
BHSCT RG Meeting dates 2019 Updated
Application Summary Flowchart
Misconduct in Research Regulations _SENATE APPROVED May 2019
Informed Consent for Research v10.0
Research Governance Audit v 7.0
Complaints from Research Participants v 6.0
HTA SOP Import of Relevant Material V4 May 2019
HTA SOP Withdrawal of Consent - Human Tissue V3 May 2019
HTA SOP Transportation of Human Tissue V4 May 2019
HTA SOP External Transfer and Export of Relevant Material V4 May 2019
HTA SOP Assessment of Risk to Human Tissue V4 May 2019
HTA SOP Assessment of Risk to Personnel for the Handling of HT V4 May 2019
HTA SOP Recording Human Tissue Act Related Adverse Events V4 May 2019
HTA SOP Internal Audit of HTA Licensed Premises V6 May 2019
HTA SOP Disposal of Human Tissue V6 May 2019
HTA SOP Receipt, Labelling, Tracking and Storage of Human Tissue V5 May 2019
HTA Training Schedule 2019-2020
Policy on the Ethical Approval of Research Jan 2019
Gov 2 form Aug 2019
FREC Flowchat No Risk FINAL
QUB Summary Sponsor flowchart v5.0
Gov 4 Aug 2019
HTA Licensing Structure Aug 2019
HTA Quality Manual v6.0 Apr 2019
EPS Faculty REC Meeting Schedule 19/20
SEHSCT Committee dates Aug 2019
MHLS FREC Proportionate Review Ethics Application
MHLS Full Review Ethics Application
MHLS Confirmation of Existing Ethical Approval Form
MHLS Faculty REC Meeting Schedule 2021 2022
Faculty REC Application Process flowchart v4 27.08.19
EPS Screening Tool 06.09.2019 v3
MHLS Screening Tool 06.09.2019 v1
FREC PIS Consent Form Template Guidance
FREC PIS Template
FREC Consent Form Template
Gov1
Peer Review Gov4
Animal Procedures per annum up to 2017
Schedule 1 2013 - 2017
BHSCT RG Meeting dates 2020
Compliance statement for 2018-19
EPS Animal Welfare Ethics Application
MHLS Animal Welfare Ethics Application
NHSCT RG Meeting dates 2020
SEHSCT RG meeting dates 2020
SHSCT RG Meeting dates 2020
WHSCT RG Meeting dates 2020
SEHSCT RG meeting dates 2020 - Update
HSC R&D Manager Details updated 19_07_16
HSC R&D Manager Details updated 13_01_2020
HTA Adverse Events Form v 4.0
External Transfer or Export of Human Tissue v3.0
Import Form v3.0
Consent Form Template
the-concordat-to-support-research-integrity 2019
Terms of Reference and Membership for RGEIC Sept 2019
Covid-19 FAQ's
Final approved Conflict Zone Policy_Updated 2020
Principles for Human Participant Research during COVID-19 Pandemic
EPS FREC 21/22 Meeting Schedule
HTA Schedule 2020-2021
HTA updated schedule 20-21
HTA Training schedule 20-21 updated 2
Regulations for Research Involving Human Participants 2020
Policy on the Ethical Approval of Research September 2020
HTA Schedule 2021 Update 2
Complaince statement for 2019-20 approved
HTA Schedule 2021/22
Creation, Control, Amendment and Storage of SOPs for Res Gov
SOP 002 Development and Review Research Protocol_Plan
SOP 003 The Ethical Approval of Research
SOP 004 Informed Consent for Research
SOP 005 Delegation of Responsibilities
SOP 006 Reporting and Managing Research Related Adverse Events
SOP 007 Preparation, Completion, Signing and Correcting Case Report Forms
SOP 008 Setting Up, Maintaining and Archiving Research Files
SOP 009 Education Training and Experience v1.0 FINAL
SOP 010 Amendments to Study Documentation
SOP 011 End of Study Declaration, Early Termination & Final Report
SOP 012 Production of Progress Reports
SOP 013 Indemnity and Sponsorship of Research Studies
SOP 014 Data Management_Collection Validation and Storage
SOP 015 Research Governance Audit
SOP 016 Matters of Non-compliance with Study Protocol
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