LIVERPOOL JOHN MOORES UNIVERSITY SPONSORSHIP OF RESEARCH PROJECTS UNDER THE RESEARCH GOVERNANCE FRAMEWORK FOR HEALTH AND SOCIAL CARE

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "LIVERPOOL JOHN MOORES UNIVERSITY SPONSORSHIP OF RESEARCH PROJECTS UNDER THE RESEARCH GOVERNANCE FRAMEWORK FOR HEALTH AND SOCIAL CARE"

Transcription

1 LIVERPOOL JOHN MOORES UNIVERSITY SPONSORSHIP OF RESEARCH PROJECTS UNDER THE RESEARCH GOVERNANCE FRAMEWORK FOR HEALTH AND SOCIAL CARE April

2 Background The Department of Health s Research Governance Framework for Health and Social Care (RGF) defines the broad principles of good research practice and is key to ensuring that health and social care research is conducted to high scientific and ethical standards. The RGF is designed to support research, protecting the participants and researchers by reducing unacceptable variations in research practice, promoting good practice and learning from mistakes. The RGF is not law but it does bring together existing legislation and guidance including The Data Protection Act, Health and Safety Legislation, Medicines for Human Use (Clinical Trials) Regulations The RGF sets out responsibilities for all involved in research: researchers (including students and their supervisors), care professionals, funding bodies, hosts, employers and sponsors of research. The standards and principles of the RGF currently apply to all research that relates to the responsibilities of the Secretary of State for Health and this includes any research undertaken by academic or independent bodies/individuals, in or with social care agencies, as well as research undertaken by those agencies themselves. A full copy of the Department of Health s Research Governance Framework for Health and Social Care (RGF) can be obtained from Department of Health: Research and Development Sponsorship All research conducted under the RGF must have an identified sponsor which the RGF defines as an individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study. Liverpool John Moores University (LJMU) would, in principle, expect to act as sole Sponsor for the following types of research where the principal investigator is a substantive employee or student of LJMU: Educational research for LJMU students where the Supervisor is an employee of the University. (Unless the research project is part of a clinical project and/or Sponsorship arrangements have already been agreed). Primarily laboratory based research at one of the LJMU sites where little clinical intervention is necessary (eg taking a blood sample from patients to take to laboratory for analysis) Questionnaire/Interview/Analysis of patient data based research involving non-clinical intervention. Should research be intrinsically clinical with prolonged intervention with NHS patients, LJMU would in the first instance expect that the lead NHS Trust involved in the research would act as the sole Sponsor of the research. 2

3 Where large multi-centre research involving a number of NHS Trusts are involved or the project appears to be more complicated than the above LJMU would expect to negotiate a specific co-sponsorship agreement with the other parties involved to clearly outline responsibilities. In these instances Research and Innovation Services will assist in drafting such an agreement. It is expected that, where research is commercially funded, the commercial organisation will accept the role of Sponsor for the work. Responsibilities Responsibilities of Principle Investigators where LJMU has agreed to be Sponsor: To ensure that: The research proposal respects the dignity, rights, safety and well-being of participants and the relationship with care professionals. The research proposal is worthwhile, of high scientific quality and represents good value for money. The research proposal has been approved by an appropriate research ethics committee. Where appropriate arrangements are in place for the registration of trials. The principal investigator and other key researchers have the necessary expertise and experience and have access to the resources needed to conduct the proposed research successfully The arrangements and resources proposed will allow the collection of high quality, accurate data and the systems and resources being proposed are those required to allow appropriate data analysis and data protection. Intellectual property rights and their management are appropriately addressed in research contracts or terms of grant awards. Arrangements proposed for the work are consistent with the Department of Health Research Governance Framework and where applicable the Medicines for Human Use (Clinical Trials) Regulations Organisations and Individuals involved in the research all agree the division of responsibilities between them. Arrangements are in place for the sponsor and other stakeholder organisations to be alerted if significant developments occur as the study progresses, whether in relation to the safety of individuals or to scientific direction. An agreement has been reached about the provision of compensation in the event of non-negligent harm. The University does not routinely provide cover for non-negligent harm, any specific requirement to provide such cover must be discussed with the University s Insurers and it is likely that an additional premium will be charged for such cover. Arrangements are proposed for disseminating the findings. Assistance is provided to any enquiry, audit or investigation related to the funded work. 3

4 Responsibilities of Schools/Departments Developing and promoting a quality research culture and ensuring staff are supported in, and held to account for, the professional conduct research. To ensure that principal investigators and/or other research staff are aware of, understand and comply with the Department of Health Research Governance Framework and that the principal investigator and other key researchers have the necessary expertise and experience and have access to the resources needed to conduct the proposed research successfully. Demonstrating systems for continuous professional development of staff at all levels. Responsibilities of LJMU To ensure: Compliance with all current employment and health and safety legislation. Promotion of clear codes of practice and mechanisms to monitor and assess compliance. To ensure that principal investigators and/or other research staff are aware of, understand and comply with this framework. Discharging their agreed role in the management and monitoring of work undertaken by their organisation. Demonstrating systems for continuous professional development of staff at all levels. Having agreements and systems in place to identify, protect and exploit intellectual property. Ensuring they are able to compensate anyone harmed as a result of negligence on the part of their staff and, if they have agreed to do so, for non-negligent harm arising from the research. Having in place systems to detect and address fraud and other scientific or professional misconduct by their staff. Having in place systems to process, address and learn lessons from any complaints brought against their employees. Permitting and assisting in any investigation arising from complaints received in respect of actions. Monitoring and Audit of Research under RGF The RGF requires that research conduct is monitored / audited appropriately before commencement, during the study and when the study is completed to ensure compliance with both the protocol and the requirements of the RGF. Broadly LJMU will act as sole sponsor for two categories of research: Undergraduate and postgraduate taught research ie student dissertations Postgraduate research studies and staff research In the case of undergraduate and postgraduate taught research studies responsibility for monitoring is delegated to the student s supervisor. The supervisor is expected to: 4

5 review the student s proposal to ensure appropriate levels of quality, feasibility and value; ensure that the student obtains the appropriate approvals to commence the study ie ethical approval, R&D approval etc; ensure that the student conducts the study in line with the protocol and any ethical requirements such as adverse event reporting ensure that the findings of the study are appropriately reported and disseminated In the case of postgraduate research studies and staff research responsibility for monitoring will rest with the University s Research Ethics Committee. Once agreement has been reached that the University will act as sole sponsor for a postgraduate research study or study conducted by a member of staff such research studies will be subjected to annual monitoring to ensure compliance with the protocol and the requirements of the RGF. This will normally take the form of a written report by the Principle Investigator to the University REC although in some cases a formal audit of all paperwork associated with the study may be conducted. In the case where LJMU is acting as co-sponsor for a study formal agreement on who will monitor the study will be made prior to commencement. A record of all studies where the University act as either sole sponsor or co-sponsorship will be kept by Research and Innovation Services All staff and students should note that where the University is required to act as sponsor for a study being conducted under the RGF this must be clearly stated in the appropriate application for ethical approval. The authorised signatory for LJMU sponsorship via the NRES application process is: Dr Diana Leighton

Essentials of RESEARCH GOVERNANCE

Essentials of RESEARCH GOVERNANCE Promoting Good Practice in Research Essentials of RESEARCH GOVERNANCE Information for Researchers, Students and Support Staff involved in Health & Social Care Research 2005 Reproduced with the permission

More information

RESEARCH GOVERNANCE FRAMEWORK

RESEARCH GOVERNANCE FRAMEWORK RESEARCH GOVERNANCE FRAMEWORK April 2006 1 of 7 Canterbury Christ Church University Research Governance Framework 1. INTRODUCTION This Framework is designed to ensure that research in the University meets

More information

Information for members

Information for members Information for members I-04-63 Suggested distribution Vice-Chancellors and Principals, Pro Vice- Chancellors (Research), University Registrars and Secretaries, Directors of Human Resources, Deans/Heads

More information

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:

More information

Research Governance Framework for Health and Social Care in Wales Second Edition

Research Governance Framework for Health and Social Care in Wales Second Edition Research Governance Framework for Health and Social Care in Wales Second Edition Contents Foreword 1 1. Purpose and Scope 3 2. Standards 7 2.1 Introduction 7 2.2 Ethics 8 2.3 Science 13 2.4 Information

More information

UNIVERSITY OF LEICESTER & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES

UNIVERSITY OF LEICESTER & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES UNIVERSITY OF LEICESTER & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL) SOP S-1005 UoL Sponsor Management

More information

Research Governance Framework for Health and Social Care

Research Governance Framework for Health and Social Care Research Governance Framework for Health and Social Care Second edition, 2005 Research Governance Framework for Health and Social Care Foreword The Research Governance Framework outlines principles of

More information

New Research Governance arrangements at the University of Sheffield

New Research Governance arrangements at the University of Sheffield New Research Governance arrangements at the University of Sheffield Foreword I am pleased to introduce this special edition on Research Governance, which demonstrates the University of Sheffield s commitment

More information

NORTH STAFFORDSHIRE R&D CONSORTIUM RESEARCH AND DEVELOPMENT DEPARTMENT POLICY ON RESEARCH GOVERNANCE

NORTH STAFFORDSHIRE R&D CONSORTIUM RESEARCH AND DEVELOPMENT DEPARTMENT POLICY ON RESEARCH GOVERNANCE NORTH STAFFORDSHIRE R&D CONSORTIUM NORTH STAFFORDSHIRE HOSPITAL NHS TRUST NORTH STAFFORDSHIRE COMBINED HEALTHCARE TRUST RESEARCH AND DEVELOPMENT DEPARTMENT POLICY ON RESEARCH GOVERNANCE POLICY NO: G02

More information

RESEARCH GOVERNANCE FRAMEWORK. for OSTEOPATHS

RESEARCH GOVERNANCE FRAMEWORK. for OSTEOPATHS Research governance framework Version: July 2007 RESEARCH GOVERNANCE FRAMEWORK for OSTEOPATHS Executive Summary The Research Governance Framework for Osteopathy is intended to demonstrate best practice

More information

RESEARCH GOVERNANCE POLICY

RESEARCH GOVERNANCE POLICY RESEARCH GOVERNANCE POLICY Policy Title Version: Approved by: Date of approval: 29 June 2015 Policy supersedes: Lead Board Director: Policy Lead (and author if different): Name of responsible committee/group:

More information

FELLOWSHIP AND TRAINING GRANTS. Terms and Conditions of Award

FELLOWSHIP AND TRAINING GRANTS. Terms and Conditions of Award FELLOWSHIP AND TRAINING GRANTS Terms and Conditions of Award These terms and conditions relate to fellowships and training grants awarded by the June Hancock Mesothelioma Research Fund (JHMRF). Acceptance

More information

gsop-32-02 - Vendor Assessment SOP page 1 of 10

gsop-32-02 - Vendor Assessment SOP page 1 of 10 gsop-32-02 - Vendor Assessment SOP page 1 of 10 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust VENDOR ASSESSMENT Research & Development

More information

Summary of the role and operation of NHS Research Management Offices in England

Summary of the role and operation of NHS Research Management Offices in England Summary of the role and operation of NHS Research Management Offices in England The purpose of this document is to clearly explain, at the operational level, the activities undertaken by NHS R&D Offices

More information

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL Page 1 of 10 Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL SOP ID Number: Effective Date:01/08/2012 Version Number & Date of Authorisation: V02,

More information

Introduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6

Introduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6 Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication

More information

Commissioning Policy (EMSCGP005V2) Defining the boundaries between NHS and Private Healthcare

Commissioning Policy (EMSCGP005V2) Defining the boundaries between NHS and Private Healthcare Commissioning Policy (EMSCGP005V2) Defining the boundaries between NHS and Private Healthcare Although Primary Care Trusts (PCTs) and East Midlands Specialised Commissioning Group (EMSCG) were abolished

More information

Legal Advice Procedure

Legal Advice Procedure Lincolnshire Partnership NHS Foundation Trust (LPFT) Legal Advice Procedure Document Type and Title: DOCUMENT VERSION CONTROL Corporate Governance Document Authorised Document Folder: New or Replacing:

More information

STANDARD OPERATING PROCEDURE. Risk Assessment of STH sponsored CTIMPs

STANDARD OPERATING PROCEDURE. Risk Assessment of STH sponsored CTIMPs Research Department STANDARD OPERATING PROCEDURE of STH sponsored CTIMPs SOP History None SOP Number C118 Created STH Research Department (EW) Reviewed STH Research Department (EW) Superseded Version 1.0,

More information

SOP Number: SOP-QA-34 Version No: 1. Version Description of Changes Date Effective. Change of number for Q-Pulse (Replaces UoA-NHSG-SOP-051 V1)

SOP Number: SOP-QA-34 Version No: 1. Version Description of Changes Date Effective. Change of number for Q-Pulse (Replaces UoA-NHSG-SOP-051 V1) Standard Operating Procedure: SOP Number: SOP-QA-34 Version No: 1 Author: Date: 1-9-15 (Carole Edwards, Lead Research Nurse, NHS Grampian) Approved by: Date: 1-9-15 (Professor Julie Brittenden, R&D Director,

More information

Research Management Framework

Research Management Framework Research Management Framework August 2010 1 1 Contents ABOUT THE RESEARCH MANAGEMENT FRAMEWORK... 3 Defining Research... 4 RESEARCH PROJECT ADMINISTRATION GUIDELINE... 6 Approval, Endorsement & Agreements...

More information

Defining the boundaries between NHS and Private Healthcare

Defining the boundaries between NHS and Private Healthcare West Midlands Strategic Commissioning Group Commissioning Policy (WM/13) Defining the boundaries between NHS and Private Healthcare Version 1 April 2010 1. Definitions Private patients are patients who

More information

Managing Risk in Clinical Research. Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey

Managing Risk in Clinical Research. Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Managing Risk in Clinical Research Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Aim of the session To explore the risks associated with clinical research and understand how

More information

P1415-956. Research Integrity. A Policy Framework on Research Ethics & Governance

P1415-956. Research Integrity. A Policy Framework on Research Ethics & Governance P1415-956 Research Integrity A Policy Framework on Research Ethics & Governance CONTENTS Section Topic Pages Forward by Pro Vice Chancellor 4 Scope 5 Executive Summary 6 1 Introduction 7 2 Responsibility

More information

ESKITP7145.01 Manage IT service delivery performance metrics

ESKITP7145.01 Manage IT service delivery performance metrics Overview This sub-discipline covers the competencies required to manage the monitoring, analysis and communication of IT service delivery performance metrics. Monitoring service level performance is a

More information

Information about research

Information about research Information about research Welcome to Papworth Hospital a focus on research As a specialist centre we pride ourselves on the quality of care that we provide for our patients. Knowledge in health care

More information

Implementing the Research Governance Framework Guidelines for New Researchers. Juliet MacArthur Alison Goulbourne

Implementing the Research Governance Framework Guidelines for New Researchers. Juliet MacArthur Alison Goulbourne Implementing the Research Governance Framework Guidelines for New Researchers Juliet MacArthur Alison Goulbourne March 2007 0 Note from the authors This document is designed to provide a step by step guide

More information

Document Title: Trust Approval and Research Governance

Document Title: Trust Approval and Research Governance Document Title: Trust Approval and Research Governance Document Number: SOP034 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D

More information

RD SOP17 Research data management and security

RD SOP17 Research data management and security RD SOP17 Research data management and security Version Number: V2 Name of originator/author: Dr Andy Mee, R&I Manager Name of responsible committee: R&I Committee Name of executive lead: Medical Director

More information

Research governance policy

Research governance policy Research governance policy Responsible Officer Author Ben Bennett, Business Planning & Resources Director Sarah Garner, Associate Director, Science Policy & Research Programme Date effective from July

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Estonia

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Estonia The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Estonia Question 1: What laws or regulations apply to an application for conducting a clinical

More information

Research Governance Policy

Research Governance Policy Research Office Research Governance Policy University of West London: Research Office, June 2008 Updated June 2015. Please note: 1. The information given in this publication is accurate at the time of

More information

Nursing Agencies. Minimum Standards

Nursing Agencies. Minimum Standards Nursing Agencies Minimum Standards 1 Contents Page Introduction 3 Values underpinning the standards 6 SECTION 1 - MINIMUM STANDARDS Management of the nursing agency 1. Management and control of operations

More information

PG Certificate / PG Diploma / MSc in Clinical Pharmacy

PG Certificate / PG Diploma / MSc in Clinical Pharmacy PG Certificate / PG Diploma / MSc in Clinical Pharmacy Programme Information September 2014 Entry School of Pharmacy Queen s University Belfast Queen s University Belfast - Clinical Pharmacy programme

More information

An introduction to Research Management and Governance (RM&G) in the NHS

An introduction to Research Management and Governance (RM&G) in the NHS An introduction to Research Management and Governance (RM&G) in the NHS Rachel Davis Assistant RM&G Project Manager Natassia Embury R&D Facilitator 14/04/2014 Delivering clinical research to make patients,

More information

STANDARD OPERATING PROCEDURE FOR RESEARCH. 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol

STANDARD OPERATING PROCEDURE FOR RESEARCH. 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 2. Notification of Serious Breaches of Good Clinical Practice or Study Protocol

More information

UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST

UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST CLINICAL NEGLIGENCE, PERSONAL INJURY, AND PROPERTY CLAIMS HANDLING POLICY APPROVED BY: THE TRUST BOARD DATE: 6 TH JUNE 2002 REVIEW: ORIGINATOR: ANNUALLY MICHAEL

More information

SFHAD4 Develop and disseminate information and advice about substance use, health and social well-being

SFHAD4 Develop and disseminate information and advice about substance use, health and social well-being Develop and disseminate information and advice about substance use, Overview For this standard you need to develop a range of information and advice materials to promote substance misuse services, and

More information

Risk Management Strategy

Risk Management Strategy Risk Management Strategy A Summary for Patients & Visitors This leaflet has been designed to provide information on the Trust s Risk Management Strategy and how we involve patients and the public in reducing

More information

Medicines for Human Use (Clinical Trials Regulations) 2004

Medicines for Human Use (Clinical Trials Regulations) 2004 Medicines for Human Use (Clinical Trials Regulations) 2004 Membership of research ethics committees 1. This note summarises the provisions for membership of recognised ethics committees set out in Schedule

More information

Contract Management Guideline

Contract Management Guideline www.spb.sa.gov.au Contract Management Guideline Version 3.2 Date Issued January 2014 Review Date January 2014 Principal Contact State Procurement Board Telephone 8226 5001 Contents Overview... 3 Contract

More information

TRIAL MASTER FILE- SPONSORED

TRIAL MASTER FILE- SPONSORED gsop-06-04 - Management of TMF for ENHT/ WHHT Sponsored CTIMPs Page 1 of 16 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust TRIAL MASTER

More information

Insurance and compensation in the event of injury in Phase I clinical trials

Insurance and compensation in the event of injury in Phase I clinical trials Insurance and compensation in the event of injury in Phase I clinical trials Guidance developed by the Association for the British Pharmaceutical Industry, the BioIndustry Association and the Clinical

More information

List of Illustrations

List of Illustrations Preface This Research Governance Framework for Health and Social Care takes account of a number of developments that have taken place since the framework was issued for consultation in 2002. Regulations

More information

Standards of Business Conduct Policy

Standards of Business Conduct Policy Standards of Business Conduct Policy Author Steph Edusei-Basra, Authorisation Development Lead Owner Alistair Blair, Chief Clinical Officer (designate) Date: 28/09/2012 Version 1.0 Final Previous version

More information

Crown Heights Medical Centre Job Description Nurse Practitioner

Crown Heights Medical Centre Job Description Nurse Practitioner JOB TITLE: REPORTS TO: HOURS: Salary Health Care Assistant Nurse (clinical) Patient Services Manager (Employment) Practice Manager (All other issues) Dependant on advertised post. Negotiable dependant

More information

PG Certificate / PG Diploma / MSc in Clinical Pharmacy

PG Certificate / PG Diploma / MSc in Clinical Pharmacy PG Certificate / PG Diploma / MSc in Clinical Pharmacy Programme Information 2010 2011 School of Pharmacy Queen s University Belfast Queen s University Belfast Clinical Pharmacy programme Distance learning

More information

Research in the NHS HR Good Practice Resource Pack

Research in the NHS HR Good Practice Resource Pack Research in the NHS HR Good Practice Resource Pack Acknowledgements The Research Passport system was first developed in Greater Manchester by a partnership of NHS organisations and the University of Manchester.

More information

MRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council

MRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council MRC Clinical Trials Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 Medical Research Council MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 MRC GUIDELINES FOR

More information

Managing Research in Hospices

Managing Research in Hospices Managing Research in Hospices Paul Perkins Consultant in Palliative Medicine Gloucestershire Hospitals NHS Foundation Trust and Sue Ryder Leckhampton Court Hospice Cheltenham Why? We need to know what

More information

Research & Development Guidance for Students

Research & Development Guidance for Students Research & Development Guidance for Students 2 Contents Introduction 3 Understanding the Research Approval Process 3 Is My Project Audit, Research or Something Else 4 What Next? 4 R&D Step by step Guide

More information

Note that the following document is copyright, details of which are provided on the next page.

Note that the following document is copyright, details of which are provided on the next page. Please note that the following document was created by the former Australian Council for Safety and Quality in Health Care. The former Council ceased its activities on 31 December 2005 and the Australian

More information

CLAIMS MANAGEMENT POLICY

CLAIMS MANAGEMENT POLICY GWASANAETHAU AMBIWLANS CYMRU YMDDIRIEDOLAETH GIG WELSH AMBULANCE SERVICES NHS TRUST CLAIMS MANAGEMENT POLICY Clinical Negligence, Personal Injury, Losses and Compensation Claims Approved by Date Review

More information

Research funding applications involving Cardiff & Vale UHB. Emma Lewis R&D Coordinator. Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a r Fro

Research funding applications involving Cardiff & Vale UHB. Emma Lewis R&D Coordinator. Cardiff and Vale UHB Bwrdd lechyd Prifysgol Caerdydd a r Fro Research funding applications involving Cardiff & Vale UHB Emma Lewis R&D Coordinator Objectives R&D review of grant applications Identifying resources required for your project Attributing costs using

More information

National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP)

National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) Operating Manual Please check the CRN Website for the latest version. Version: 6.0 Status: Consultation in

More information

Managing General Agents (MGAs) Guideline

Managing General Agents (MGAs) Guideline Managing General Agents (MGAs) Guideline JUNE 2013 DRAFT FOR COMMENT BC AUTHORIZED LIFE INSURERS www.fic.gov.bc.ca PURPOSE This draft guideline outlines best practices that the Financial Institutions Commission

More information

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name

More information

ROYAL COLLEGE OF CHIROPRACTORS (RCC) PHD STUDENTSHIP GRANTS TERMS & CONDITIONS OF AWARD

ROYAL COLLEGE OF CHIROPRACTORS (RCC) PHD STUDENTSHIP GRANTS TERMS & CONDITIONS OF AWARD ROYAL COLLEGE OF CHIROPRACTORS (RCC) PHD STUDENTSHIP GRANTS TERMS & CONDITIONS OF AWARD Introduction These terms and conditions relate to RCC PhD Studentship Grants (SGs). An SG is a grant paid by the

More information

The new EU Clinical Trials Regulation How NHS research and patients will benefit

The new EU Clinical Trials Regulation How NHS research and patients will benefit the voice of the NHS in Europe Briefing September 2014 Issue 19 The new EU Clinical Trials Regulation How NHS research and patients will benefit Who should read this briefing? This briefing will be of

More information

ESKISP6056.01 Direct security testing

ESKISP6056.01 Direct security testing Direct security testing Overview This standard covers the competencies concerning with directing security testing activities. It includes setting the strategy and policies for security testing, and being

More information

Managing the boundaries of NHS and privately funded healthcare Policy on the separation of private and NHS treatments

Managing the boundaries of NHS and privately funded healthcare Policy on the separation of private and NHS treatments South Central Priorities Committees (Oxfordshire PCT) Policy Statement 67a: Managing the boundaries of NHS and privately-funded healthcare Clinical Executive decision: September 2009 Date of Issue: April

More information

Document Title: Research Database Application (ReDA)

Document Title: Research Database Application (ReDA) Document Title: Research Database Application (ReDA) Document Number: SOP035 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D

More information

NAVIGATING ETHICAL APPROVAL AND ACCESS IN SOCIAL CARE RESEARCH

NAVIGATING ETHICAL APPROVAL AND ACCESS IN SOCIAL CARE RESEARCH NAVIGATING ETHICAL APPROVAL AND ACCESS IN SOCIAL CARE RESEARCH January 2014 Preamble This document has been produced by the Scottish Government, the Association of Directors of Social Work (ADSW) and the

More information

Clinical Trials - Insurance and Indemnity

Clinical Trials - Insurance and Indemnity Policy Directive Clinical Trials - Insurance and Indemnity Document Number PD2011_006 Publication date 25-Jan-2011 Functional Sub group Corporate Administration - Governance Clinical/ Patient Services

More information

CHILDREN AND ADULTS SERVICE RESEARCH APPROVAL GROUP

CHILDREN AND ADULTS SERVICE RESEARCH APPROVAL GROUP DURHAM COUNTY COUNCIL CHILDREN AND ADULTS SERVICE RESEARCH APPROVAL GROUP INFORMATION PACK Children and Adults Service Version 4 October 2015 Children and Adults Service Research Approval Group Page 1

More information

Definitions used in these Grant Conditions can be found at paragraph 13.

Definitions used in these Grant Conditions can be found at paragraph 13. GRANT CONDITIONS These Grant Conditions, together with the Award Letter and the Policies and Positions Statements, set out the terms and conditions on which the Grant is made by the Funders to the Host

More information

Study-wide considerations: identifies the areas of the criterion the lead reviewer should consider when conducting the review

Study-wide considerations: identifies the areas of the criterion the lead reviewer should consider when conducting the review UK STUDY-WIDE GOVERNANCE CRITERIA FOR R&D REVIEW INTRODUCTION The following document is intended to provide operational guidance to the person taking the UK lead in conducting the R&D Study-Wide review

More information

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009 Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009 The innovative pharmaceutical industry 2 is committed to the transparency

More information

Policy Flowchart. Policy Title: Research Governance, Conduct and Management Policy. Reference and Version No: IG6 Version 5

Policy Flowchart. Policy Title: Research Governance, Conduct and Management Policy. Reference and Version No: IG6 Version 5 Policy Title: Research Governance, Conduct and Management Policy Reference and Version No: IG6 Version 5 Author and Job Title: J Greenaway Research and Development Manager Executive Lead Medical Director

More information

Job Description. Professionally accountable to the Medical Director with respect to Trust-wide Medicines Optimisation.

Job Description. Professionally accountable to the Medical Director with respect to Trust-wide Medicines Optimisation. Job Description JOB DETAILS Job Title: Chief of Pharmacy Band: 9 Hours: 37.5 Department / Ward: Directorate: Pharmacy Cross Site Central Clinical Services ORGANISATIONAL ARRANGEMENTS Operationally accountable

More information

Leading Care Job Description Core Elements For Ward Sisters /Charge Nurses (AfC Band 7)

Leading Care Job Description Core Elements For Ward Sisters /Charge Nurses (AfC Band 7) Leading Care Job Description Core Elements For Ward Sisters /Charge Nurses (AfC Band 7) 15 July 2011 Version 2 Ward Sister Charge Nurse Band 7 Job Description The Chief Nursing Officer requested the Northern

More information

South East Coast Ambulance Service NHS Trust. Information Governance Working Group. Terms of Reference

South East Coast Ambulance Service NHS Trust. Information Governance Working Group. Terms of Reference South East Coast Ambulance Service NHS Trust Information Governance Working Group Terms of Reference 1. Constitution 1.1. The Board hereby resolves to establish a Working Group of the Risk Management &

More information

POLICY FOR THE GOVERNANCE OF RESEARCH INVOLVING HUMAN PARTICIPANTS

POLICY FOR THE GOVERNANCE OF RESEARCH INVOLVING HUMAN PARTICIPANTS POLICY FOR THE GOVERNANCE OF RESEARCH INVOLVING HUMAN PARTICIPANTS Version 4 (10/15) POLICY FOR THE GOVERNANCE OF RESEARCH INVOLVING HUMAN PARTICIPANTS AND THE ACCOMPANYING PROCEDURES CONTENTS Page No.

More information

Date : Date of start of procedure: Authorisation/ positive opinion :

Date : Date of start of procedure: Authorisation/ positive opinion : Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use,

More information

Standard Operating Procedures (SOP) Research and Development Office

Standard Operating Procedures (SOP) Research and Development Office Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Undertaking Risk Assessment of a Research and Development Project SOP Number: 33 Version Number: 1.0 Supercedes: N/A Effective

More information

General Register Office for Scotland information about Scotland s people. Paper NHSCR GB 1/08. NHSCR Scotland Information Governance Standards

General Register Office for Scotland information about Scotland s people. Paper NHSCR GB 1/08. NHSCR Scotland Information Governance Standards General Register Office for Scotland information about Scotland s people Paper NHSCR GB 1/08 NHSCR Scotland Information Governance s This is a draft on which the Board s comments would be welcome. Contents

More information

Guidelines for Managers on receipt of a request for financial compensation from a Complainant (Remedy)

Guidelines for Managers on receipt of a request for financial compensation from a Complainant (Remedy) Guidelines for Managers on receipt of a request for financial compensation from a Complainant (Remedy) Amendments Date Page(s) Comments Approved by Aug 2011 General review and update. Changes Head of Patient

More information

1.2 Evidence-based practice 1.3 Environment 1.4 Multi-professional working 2. Enhance the patient/client experience 2.1 Person-centred care

1.2 Evidence-based practice 1.3 Environment 1.4 Multi-professional working 2. Enhance the patient/client experience 2.1 Person-centred care JOB DESCRIPTION Title of Post: Diabetes Specialist Nurse Grade of Post: Band 7 Reports to: Accountable to: Location: Hours: Clinical Manager Assistant Director Medical Specialties Diabetes Acute Services

More information

Internal Audit FINAL INTERNAL AUDIT REPORT. Management Initiated Review of Child Support Master Program Payments

Internal Audit FINAL INTERNAL AUDIT REPORT. Management Initiated Review of Child Support Master Program Payments Australian Government Department of Human Services Internal Audit FINAL INTERNAL AUDIT REPORT Management Initiated Review of Child Support Master Program Payments Report Number Conducted May - June 2012

More information

The Code Standards of conduct, performance and ethics for nurses and midwives

The Code Standards of conduct, performance and ethics for nurses and midwives The Code Standards of conduct, performance and ethics for nurses and midwives The people in your care must be able to trust you with their health and wellbeing. To justify that trust, you must make the

More information

abcdefghijklmnopqrstu

abcdefghijklmnopqrstu Chief Medical Officer and Public Health Directorate abcdefghijklmnopqrstu T: 0131-244-2235 F: 0131-244-2989 E: veronica.moffat@scotland.gsi.gov.uk Dear Colleague ARRANGEMENTS FOR NHS PATIENTS RECEIVING

More information

Job Description. Pay band 6

Job Description. Pay band 6 Job Description Job title Pay band 6 Reports to eam leader Location Holborn, London WC1 or Harrogate Job summary Promoting the highest possible standards of patient care, and employee and public safety,

More information

The code: Standards of conduct, performance and ethics for nurses and midwives

The code: Standards of conduct, performance and ethics for nurses and midwives The code: Standards of conduct, performance and ethics for nurses and midwives We are the nursing and midwifery regulator for England, Wales, Scotland, Northern Ireland and the Islands. We exist to safeguard

More information

UK policy framework for health and social care research. Issued for public consultation

UK policy framework for health and social care research. Issued for public consultation UK policy framework for health and social care research Issued for public consultation Introduction and background 1. Context... 1 2. Purpose... 2 3. Scope... 3 4. Implementation... 4 5. UK-wide responsibilities...

More information

NHS CHOICES COMPLAINTS POLICY

NHS CHOICES COMPLAINTS POLICY NHS CHOICES COMPLAINTS POLICY 1 TABLE OF CONTENTS: INTRODUCTION... 5 DEFINITIONS... 5 Complaint... 5 Concerns and enquiries (Incidents)... 5 Unreasonable or Persistent Complainant... 5 APPLICATIONS...

More information

1.1 Profession: Senior Academic Health Psychologist

1.1 Profession: Senior Academic Health Psychologist CPD profile 1.1 Profession: Senior Academic Health Psychologist 1.2 CPD number: CPD1234 2. Summary of recent work/practice I have been working as a psychology lecturer in higher education for twenty years

More information

We are the nursing and midwifery regulator for England, Wales, Scotland, Northern Ireland and the Islands.

We are the nursing and midwifery regulator for England, Wales, Scotland, Northern Ireland and the Islands. The Prep handbook We are the nursing and midwifery regulator for England, Wales, Scotland, Northern Ireland and the Islands. We exist to safeguard the health and wellbeing of the public. We set standards

More information

What is necessary to provide good clinical data for a clinical trial?

What is necessary to provide good clinical data for a clinical trial? What is necessary to provide good clinical data for a clinical trial? Alain Barrois, Assistant Clinical Trials Operations Manager #EBMT2015 www.ebmt.org Is this a (typical) clinical trial? 2 Agenda Introduction

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2012) Sweden

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2012) Sweden The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe Sweden Question 1: What laws or regulations apply to an application for conducting a clinical trial in Sweden?

More information

NHS Constitution The NHS belongs to the people. This Constitution principles values rights pledges responsibilities

NHS Constitution The NHS belongs to the people. This Constitution principles values rights pledges responsibilities for England 21 January 2009 2 NHS Constitution The NHS belongs to the people. It is there to improve our health and well-being, supporting us to keep mentally and physically well, to get better when we

More information

Defining the Boundaries Between NHS and Private Healthcare

Defining the Boundaries Between NHS and Private Healthcare Defining the Boundaries Between NHS and Private Healthcare Policy: COM 30 Document Version Control Version 0.1 Draft Pilot version 08/07/09 Version 1.0 Ratified 07/09/09 Version Version Version Version

More information

Good Scientific Practice

Good Scientific Practice Section 1: The purpose of this document There are three key components to the Healthcare Science workforce in the UK: 1. Healthcare Science Associates and Assistants who perform a diverse range of task

More information

Defining the boundaries between NHS and Private Healthcare

Defining the boundaries between NHS and Private Healthcare Commissioning Policy (EMSCGP005V2) Defining the boundaries between NHS and Private Healthcare 1. Definitions Private patients are patients who receive private healthcare, funded on a pay-asyou-go basis

More information

The Research Capability Programme. Peter Knight, Group Programme Director

The Research Capability Programme. Peter Knight, Group Programme Director The Research Capability Programme Peter Knight, Group Programme Director 11/03/2010 RESEARCH FOR PATIENT BENEFIT WORKING PARTY FINAL REPORT For us, science and research constitute a front-line service,

More information

HEALTH AND COMMUNITY EMPLOYEES PSYCHOLOGISTS (STATE) AWARD

HEALTH AND COMMUNITY EMPLOYEES PSYCHOLOGISTS (STATE) AWARD IRC No 423 of 2015 Walton P New Award effective 1 July 2015 IRC IIIRCSCC HEALTH AND COMMUNITY EMPLOYEES PSYCHOLOGISTS (STATE) AWARD INDUSTRIAL RELATIONS COMMISSION OF NEW SOUTH WALES Arrangement Clause

More information

The University of Edinburgh. College of Medicine and Veterinary Medicine. Western General Hospital Site. Royal Edinburgh Hospital Site

The University of Edinburgh. College of Medicine and Veterinary Medicine. Western General Hospital Site. Royal Edinburgh Hospital Site The University of Edinburgh College of Medicine and Veterinary Medicine Western General Hospital Site Royal Edinburgh Hospital Site HEALTH AND SAFETY Insurance Contents Aim 1 Introduction 2 Public Liability

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark Question 1: What laws or regulations apply to an application for conducting a clinical

More information

1.1 An initial request to enter into a contractual arrangement may be initiated by either Massey University or another party (Other Party).

1.1 An initial request to enter into a contractual arrangement may be initiated by either Massey University or another party (Other Party). CONTRACT MANAGEMENT PROCEDURE Section Risk Management Contact Risk Manager Last Review February 2013 Next Review February 2016 Approval Not required Procedures Contract Initiation Request Mandatory Guidance

More information

NHS England Complaints Policy

NHS England Complaints Policy NHS England Complaints Policy 1 2 NHS England Complaints Policy NHS England Policy and Corporate Procedures Version number: 1.1 First published: September 2014 Prepared by: Kerry Thompson, Senior Customer

More information

RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING

RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Introduction 2 2. Scope 2 3. Documents to be archived 2 4. Quality of essential documents 10 5.

More information