File Store

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 Sept 2020 2021

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 20/21 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