Title: Obtaining NHS Permission at UCLH

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Title: Obtaining NHS Permission at UCLH"

Transcription

1 Title: Obtaining NHS Permission at UCLH SOP Number and Version: 3, V1 Effective Date: 24/02/2015 Review Date: 24/02/2018 Please check this is the latest version of the SOP on the Joint Research Office website: Author: Name: Suzanne Binks Position: Quality Assurance Coordinator (Research Governance) Signature Date Approved by: Name: Rajinder Sidhu Position: Director of Research Support Signature Date Authorised by: Name: Nick McNally Position: Director of Research Support Signature Date Page 1 of 10

2 Revision Chronology: Version Number: Effective date: Reason for change: Author: 1 24/02/2015 Initial standardised SOP for use within UCLH. Suzanne Binks ACRONYMS ARSAC CAG CCTU CI CRF CRN CRO CSP CTIMP DCD IMP IRAS ISF JRO LO LWENC MHRA NIHR PI PAF REC SOP SSI TFC Administration of Radioactive Substances Advisory Committee Confidentiality Advisory Group Cancer Clinical Trials Unit Chief Investigator Clinical Research Facility Clinical Research Network Clinical Research Office Coordinated System for Gaining NHS Permission (for all studies going through NIHR portfolio adoption). Clinical Trial of Investigational Medicinal Product Divisional Clinical Director Investigational Medicinal Products Integrated Research Application System Investigator Site File Joint Research Office Liaison Officer Leonard Wolfson Experimental Neurology Centre Medicines and Healthcare Products Regulatory Agency National Institute for Health Research Principal Investigator Portfolio Adoption Form Research Ethics Committee Standard Operating Procedure Site Specific Information Trial Facilitation Committee BACKGROUND The Sponsor is responsible for the management of research studies and therefore must ensure the appropriate governance arrangements are in place, including an favourable ethical opinion from the REC (if applicable) and any other relevant regulatory approvals prior to undertaking research at the Trust site. There is also a need to assess local feasibility and to obtain local NHS Permission (R&D approval). It is a condition of the Research Governance Framework (2 nd edition, 2005) that relevant regulatory approvals and NHS Permission are in place before conducting health and social care research at UCLH. PURPOSE The SOP describes the procedure for obtaining NHS permission from the JRO prior to recruiting participants at UCLH. As part of the Harmonisation process, one of four Trust Page 2 of 10

3 Permission Centres will process and issue NHS Permission for a study to take place at UCLH, depending on the disease area (appendix 1). Harmonisation applies to routes a. and b. below only. There are three pathways to obtaining NHS permission at UCLH; a. Commercially sponsored studies (Commercial Harmonisation - appendix 2). b. Non-commercially sponsored studies proceeding through CSP (Non-commercial Harmonisation appendix 3). c. Non-commercially sponsored studies not proceeding through CSP (appendix 4). Where a study falls under the remit of the harmonisation process (routes a and b) and the permission centre is not UCLH, the JRO will not be involved in issuing NHS Permission. PROCEDURE Actions (When? How?) 1 Creating an IRAS Account The Sponsor representative and CI submitting an application to the REC (and other relevant regulatory bodies) and to the JRO will require an IRAS account to be created. The PI will also require an IRAS account to electronically sign the PI declaration in section 23 of the SSI form. Responsible persons (Who?) Sponsor, CI, PI, or Individuals registering with IRAS for the first time will need to create an account at 2 NIHR Portfolio Adoption Studies funded by industry and non-commercial organisations registered as partner organisations of the NIHR qualify for adoption onto the NIHR portfolio. Sponsor, CI or A Portfolio Adoption Form should be submitted via IRAS for adoption onto the NIHR portfolio. This can be generated by ticking yes to question 5b on the project filter questions on IRAS. 3 Required Forms for Review IRAS will produce the necessary forms for submission to the relevant review bodies (e.g. R&D, REC and MHRA). Not all review bodies will be relevant for every study, and therefore it is very important to answer the filter questions at the beginning of the IRAS dataset accurately to ensure the correct study type is identified and the relevant form sections generated. 4 Trial Facilitation Committee (TFC) and CRF adoption Cancer studies must be submitted to a TFC to assess local feasibility. The requirement for this should be confirmed by the local research team. As part of the feasibility, a local risk assessment will be performed to highlight any issues and consideration given to how to mitigate these risks. Clinical Research Facilities considering studies for adoption will also have their own review committees in place. Sponsor, CI, PI or PI or Studies taking place in a Clinical Research Facility (CRF) must also seek authorisation from the relevant review board for this facility. 5 Transfer of Site Specific Information (SSI) Forms Following TFC agreement that a study can go ahead, the PI/ should confirm this with the Sponsor and obtain timelines. The SSI should then be Sponsor, PI, Page 3 of 10

4 transferred to the PI/delegate for completion of local study site details. 6 Authorisations Check and send the IRAS forms to the relevant persons for authorisation (e.g. CI, Sponsor s representative or PI) for review and electronic authorisation. 7 Submitting Forms and Documentation for Review For studies proceeding through CSP, documents should be submitted for NHS permission through IRAS. For studies that are not proceeding through CSP, documents should be sent directly to the JRO. Authorisation signatories Sponsor or The checklist of documents that are required for the JRO to review can be found in appendices 4 and 5 (requirements for commercial studies and non-commercial studies respectively). 8 Contract Review Not all studies will require a contract. Where a sponsor s template has been provided as part of the submission, this will be reviewed against the correct model agreement template, and finalised ensuring that all legal requirements are in place. The Contracts Manager will determine whether an agreement is required where a template has not been provided by a sponsor. 9 Costing Review For commercially sponsored studies, the NIHR Industry costing template and protocol will be used to ensure the study is appropriately costed. Where the study is not commercially sponsored, the SSI form will be used to ensure adequate funding is in place for the procedures involved. 10 Pharmacy Review For trials including medicinal products a review will be conducted by Pharmacy. 11 Radiology Review For trials involving imaging procedures, a review will be conducted by Radiology. 12 Divisional Clinical Director Review Authorisation will be sought from the Clinical Director of the division in which the research is taking place. 13 Research Passport Where researchers without a UCLH contract are coming onto UCLH premises to conduct research, a Letter of Access or Honorary Contract will need to be obtained from the JRO. Please refer to the guidance on the website. 14 ARSAC Research Licence Where nuclear medicine procedures include radiation doses over and above standard practice as mandated within a protocol, an ARSAC licence will be required. It is important to liaise with the Nuclear Medicine Department who will coordinate the ARSAC application. 15 Issuing NHS Permission Once all the above steps have been completed, NHS permission can be issued. A letter will be sent via to the PI for the study, listing the conditions of approval. JRO Contracts Manager JRO Cost Accountant Clinical Trial Pharmacist Radiology Coordinator Divisional Clinical Director Researcher, JRO Administrator PI or, Nuclear Medicine Sponsor or Delegated Individual Sponsors should not circulate an open to recruitment letter and no participant documentation should be handed to potential participants prior to receiving this letter. 16 Starting the Study Upon receipt of a Trust NHS permission letter, a member of the research team may Delegated Page 4 of 10

5 need to ensure that all necessary approvals and actions have been undertaken. and confirm with Pharmacy that the study (if applicable) has been set-up as a validated protocol on Chemo-care. Once confirmed, the open to recruitment letter should be circulated to all relevant service department staff, Investigators and R&D. REFERENCES Health Research Authority IRAS NIHR Clinical Research Network Portfolio APPENDICES Appendix 1: Permission centres and their disease areas University College London Hospitals NHS Foundation Trust (UCLH) Cancer Non-malignant Haematology Nervous System Disorders Dementias and Neurodegenerative Disorders Stroke Diabetes Endocrine and Metabolic Ophthalmology Great Ormond Street Hospital NHS Foundation Trust (GOSH) Paediatrics Ear, Nose and Throat Reproductive Health and Childbirth Genetics Barts Health NHS Trust (Barts) Gastroenterology Hepatology (non-commercial studies) Surgery, Critical Care, Accidents and Aesthetics Musculoskeletal and Immunology and Inflammation Dermatology Infectious Diseases and Microbiology (noncommercial studies) Renal and Urology Respiratory (non-commercial) Cardiovascular North Central London Research Consortium (NoCLoR) Public Health Research Health Services Research Oral and Dental Mental Health Primary Care Age and Ageing Respiratory (commercial studies) Infectious Diseases and Microbiology (commercial studies) Hepatology (commercial studies) Page 5 of 10

6 Appendix 2: Commercial Harmonisation Pathway UCLH PERMISSION CENTRE (PC) notified of new study via (from CSP team, study team, sponsor or CRO) Study wide /Local checks Study registered on internal database and allocated to a Liaison Officer (LO) LO sends to CI/PI/sponsor introducing the harmonisation process and initiates all applicable internal review processes: Costing review Contract review Pharmacy review (CTIMP studies only) Imaging review (studies involving ionising radiation) Obtain Divisional Clinical Director (DCD) authorisation Confirm review and adoption of study with CRF/TFC Contract finalised. LO requests partially signed agreements from study sponsor LO receives partially signed contract and obtains internal signatures Portfolio adoption form (PAF) list North Thames as Lead LCRN LO conducts study wide review Local SSI submission submitted by study team LO conducts local checks Contracts fully signed Pharmacy, imaging and DCD authorisation obtained Study wide (if applicable) and local checks completed LO request Portfolio Database Administrator (PDA) to grant NHS Permission PDA issues NHS permission letter to PI and sends contract via . LO returns hard copies of the contract to the sponsor/study team. Page 6 of 10

7 Appendix 3: Non-commercial Harmonisation Pathway Permission Centre (PC) is notified about the study at PAF submission stage. Permission Centre initiates costing and contract reviews and completes the Study Wide review Study team completes SSI submission. Divisional Portfolio Officer (DPO) validates and informs the study team of the outcome. Cost Accountant completes the costing and sends to the Divisional Portfolio Officer (DPO) and Contracts Manager DPO initiates all applicable internal review processes: Imaging review (studies involving ionising radiation) Pharmacy review (CTIMPs only) Obtain Divisional Clinical Director (DCD) authorisation Confirm review and adoption of study with CRF/TFC Research Passport application for letter of access or honorary contract Internal reviews complete and confirmed Letter of access/ honorary contract ready for issue The Divisional Portfolio Officer instructs Permission Centre to issue NHS Permission letter. Contract manager completes the Contract Review and sends to PI and Sponsor for review and signatures once costing is confirmed. Permission Centre issues NHS permission letter to PI and sends contract via . Letter of access/honorary contract is issued to research team member(s). Hard copies of the contract sent to the sponsor/study team Receipt of fully signed contracts Portfolio Adoption Team (PAF) Confirms Portfolio Eligibility If North Thames Lead CRN, Permission Centre completes Study Wide Review and requests Quality Check from LCRN Final NHS Permission Divisional Clinical Director (DCD) authorisation Pharmacy authorisation Radiology authorisation Costing review complete Contract fully signed Study Wide review complete Local Review Completed Portfolio Eligibility confirmed Page 7 of 10

8 Appendix 4: Non-commercial Non-harmonisation Pathway Document set for a new study received by JRO through R&D inbox: (see submission checklists in appendices 4 and 5) Study is registered on R&D internal database and allocated to a Portfolio Coordinator (PC) The PC begins local review of the study and initiates all applicable internal review processes: Costing review Contract review Pharmacy review (CTIMP studies only) Imaging review (studies involving ionising radiation) Divisional Clinical Director (DCD) authorisation Research Passport application for letter of access or honorary contract Confirm review and adoption of study with CRF/TFC Documentation checked for completeness Contract/costing finalised. Partially signed agreements requested from the counter party Contracts received and signed by UCLH signatory Internal reviews complete and confirmed Letter of access/ honorary contract ready for issue NHS Permission letter is issued to the Principal Investigator via . Letter of access/honorary contract is issued to research team member(s). Hard copies of contracts sent to counter party/study team. Page 8 of 10

9 Appendix 5: Commercial study submission checklist For studies proceeding through CSP, submit via IRAS. For studies not proceeding through CSP, submit via Item Documents Requirements Tick IRAS Forms 1. R&D Form Fully signed and dated by the CI and Sponsor (and any other signatories) 2. REC form Optional fully signed and dated by the CI and Sponsor (and any other signatories) 3. SSI form Fully signed and dated by the PI Supporting study documents 4. Protocol Latest REC approved version 5. REC approval All the correspondence related to REC, this includes provisional approvals, response to further clarification & any amendments made since the original approval and related correspondence 6. Participant Information Sheet Latest REC approved version localised & on local site headed paper 7. Consent Forms Latest REC approved version localised & on local site headed paper 8. GP Information sheet/letter (If applicable) Latest REC approved version localised & on local site 9. Advertisement & Invitation Letter headed paper (If applicable) Latest REC approved version localised & on local site headed paper e.g. Participant invitation letters, posters, newspaper, website adverts, diary care, questionnaires etc. 10. MHRA approval (If applicable) All correspondence related to MHRA, this includes Objections and response to further clarification and any amendments made since the original approval/objection 11. ARSAC Certificate Applicable where exposure to radioactive material is involved that is in addition to routine care 12. Investigator s Brochure Latest REC approved version - applicable for device trials and CTIMPs only 13. SmPC Latest REC approved version - applicable for trials involving drugs 14. Evidence of valid Insurance Fully signed and dated 15. Contract Template As agreed for harmonisation studies i.e. ABPI 2011 mcta 16. Costing Template Completed NIHR industry costing template Additional Supporting documents 17. CV for Principal Investigator Most up to date version. Please DO NOT include personal details on 18. CVs of all members of the local research team 19. GCP Certificates for all members of the local team (as listed on the SSI form) the CV e.g. home address, date of birth For those listed on SSI form. Most up to date. DO NOT include personal home addresses & details on the CV s Applicable for CTIMPs only. Please ensure this is no more than 2 years old. 20. Other Regulatory approvals Any other e.g. CAG, GTAG, etc. and all correspondence 21. Research Passports Applicable where members of the local research team are not directly employed by the local research site. 22. Anticipated site initiation date Optional: This information will help us to work towards a deadline Page 9 of 10

10 Appendix 6: Non-commercial study submission checklist For studies proceeding through CSP, submit via IRAS. For studies not proceeding through CSP, submit via Item Documents Requirements Tick IRAS Forms 1. R&D Form Fully signed and dated by the CI and Sponsor (and any other signatories) 2. REC form Optional fully signed and dated by the CI and Sponsor (and any other signatories) 3. SSI form Fully signed and dated by the PI 4. Portfolio CSP Reference No Applicable if the study is going through the NIHR CSP Portfolio route Supporting study documents 5. Protocol Latest REC approved version 6. REC approval All the correspondence related to REC, this includes provisional approvals, response to further clarification & any amendments made since the original approval and related correspondence 7. Participant Information Sheet Latest REC approved version localised & on local site headed paper 8. Consent Forms Latest REC approved version localised & on local site headed paper 9. GP Information sheet/letter (If applicable) Latest REC approved version localised & on local site headed paper 10. Advertisement & Invitation (If applicable) Latest REC approved version localised & on local site Letter headed paper e.g. Participant invitation letters, posters, newspaper, website adverts, diary care, questionnaires etc. 11. MHRA approval (If applicable) All correspondence related to MHRA, this includes Objections and response to further clarification and any amendments made since the original approval/objection 12. ARSAC Certificate Applicable where exposure to radioactive material is involved that is in addition to routine care 13. Investigator s Brochure Latest REC approved version - applicable for device studies and CTIMPs only 14. SmPC Latest REC approved version - applicable for trials involving drugs only 15. Evidence of valid Insurance Fully signed and dated 16. Contract Template (If applicable) e.g. mnca, MTA, DTA 17. Funding or Grant award letter Fully signed and dated Additional Supporting documents 18. CV for Principal Investigator Most up to date version. Please DO NOT include personal details on the 19. CVs of all members of the local research team 20. GCP Certificates for all members of the local team (as listed on the SSI form) CV e.g. home address, date of birth For those listed on SSI form. Most up to date. DO NOT include personal home addresses & details on the CV s Applicable for CTIMPs only. Please ensure this is no more than 2 years old. 21. Other Regulatory approvals Any other e.g. CAG, GTAC, etc. and all correspondence 22. Research Passports Applicable where members of the local research team are not directly employed by the local research site. 23. Anticipated site initiation date Optional: This information will help us to work towards a deadline Page 10 of 10

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

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

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

CLINICAL RESEARCH NETWORK

CLINICAL RESEARCH NETWORK CLINICAL RESEARCH NETWORK Introduction The vision of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. This document sets out how the

More information

Trust/Host Site Approval. Presented by: Anika Kadchha Research Governance Officer

Trust/Host Site Approval. Presented by: Anika Kadchha Research Governance Officer Trust/Host Site Approval Presented by: Anika Kadchha Research Governance Officer Joint Research & Enterprise Office Training 19 th January Outline What is Research NHS Ethics (if required) Host Site Approval

More information

Joint Research Office

Joint Research Office Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Postal Address: UCL, Gower Street London WC1E 6BT Email: hameedah.bogle-dawoud@nhs.net Tel No. 020

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

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

JRO RMG RSS SOP 12. Standard Operating Procedure (SOP) for Study Closedown and Archiving Royal Free site specific SOP

JRO RMG RSS SOP 12. Standard Operating Procedure (SOP) for Study Closedown and Archiving Royal Free site specific SOP Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Tel No. 0845 1555 000 Web-sites: www.uclh.nhs.uk; www.ucl.ac.uk/jro Postal Address: UCL, Gower Street

More information

RESEARCH AND DEVELOPMENT GAINING NHS RESEARCH PERMISSION FROM CARDIFF AND VALE UHB - GUIDANCE FOR RESEARCHERS. Research Governance Group

RESEARCH AND DEVELOPMENT GAINING NHS RESEARCH PERMISSION FROM CARDIFF AND VALE UHB - GUIDANCE FOR RESEARCHERS. Research Governance Group RESEARCH AND DEVELOPMENT GAINING NHS RESEARCH PERMISSION FROM CARDIFF AND VALE UHB - GUIDANCE FOR RESEARCHERS Reference No: UHB 074 Version No: 5 Previous Trust / LHB Ref No: N/A Documents to read alongside

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

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

CONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator

CONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator Research Department STANDARD OPERATING PROCEDURE STH Investigator Archiving of Essential Documentation Generated During Clinical Research SOP Number A127 Version Number V1.3 Effective Date Author Zoe Whiteley

More information

Health and Care Research Wales Specialty Leads. Information Pack

Health and Care Research Wales Specialty Leads. Information Pack Health and Care Research Wales Specialty Leads Information Pack Background Health and Care Research Wales funds an extensive research development and delivery infrastructure to support high-quality clinical

More information

Document Title: Project Management of Papworth Sponsored Studies

Document Title: Project Management of Papworth Sponsored Studies Document Title: Project Management of Papworth Sponsored Studies Document Number: SOP009 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G

More information

Clinical Research Facility: Feasibility Form

Clinical Research Facility: Feasibility Form SHEFFIELD CLINICAL RESEARCH FACILITY FEASIBILITY REVIEW The Clinical Research Facility (CRF) is a resource available to all clinical researchers within Sheffield which provides a specialist environment

More information

Best research for best practice: policy and practice in clinical research nursing. RCN Research Society Supported by Nurse Researcher

Best research for best practice: policy and practice in clinical research nursing. RCN Research Society Supported by Nurse Researcher Best research for best practice: policy and practice in clinical research nursing RCN Research Society Supported by Nurse Researcher Understand new research infrastructures and opportunities within the

More information

Archiving of Research Documentation

Archiving of Research Documentation Suspension, Termination & Completion Standard Operating Procedure VERSION / REVISION: 2.0 EFFECTIVE DATE: 28 05 12 REVIEW DATE: 28 05 14 AUTHOR(S): CONTROLLER: APPROVED BY: Clinical Trials Manager; Recruitment

More information

PERFORMANCE IN INITIATING CLINICAL RESEARCH (PI) CLINICAL TRIALS DATA RECORD ADJUSTMENT PROCESS

PERFORMANCE IN INITIATING CLINICAL RESEARCH (PI) CLINICAL TRIALS DATA RECORD ADJUSTMENT PROCESS PERFORMANCE IN INITIATING CLINICAL RESEARCH (PI) CLINICAL TRIALS DATA RECORD ADJUSTMENT PROCESS Version Control Amended small error in Acronyms table (page 2) 1 Acronyms CTP FPR MHRA REC SOP TMB VRA Clinical

More information

Proportionate Review (PR) IRAS Application & Documents. Authorisations & Signatures. Contact CBS Team

Proportionate Review (PR) IRAS Application & Documents. Authorisations & Signatures. Contact CBS Team Proportionate Review (PR) What is Proportionate Review? Is my study suitable for Proportionate Review? IRAS Application & Documents What is an IRAS application form? What documents do I need? Completing

More information

NIHR Guideline B01 Research & Development Operational Capability Statement V 5 2015-16 Updated March 20145

NIHR Guideline B01 Research & Development Operational Capability Statement V 5 2015-16 Updated March 20145 NIHR Guideline B01 Research & Development Operational Capability Statement V 5 2015-16 Updated March 20145 Version History Version number Valid from Valid to Date approved Approved by Updated by RDOCS

More information

Dorset Research Consortium. Research Governance: A handbook for Researchers in Dorset

Dorset Research Consortium. Research Governance: A handbook for Researchers in Dorset Dorset Research Consortium Research Governance: A handbook for Researchers in Dorset DRC Version 1 dated 25 th July 2012 Research Governance: The Basics... 4 What is Research Governance?... 4 The Research

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

SOP ID Number: JRO/INV/S02/04 Effective Date: 17/10/11. Version Number & Date of Authorisation:V04,10/10/11 Review Date: 17/10/13

SOP ID Number: JRO/INV/S02/04 Effective Date: 17/10/11. Version Number & Date of Authorisation:V04,10/10/11 Review Date: 17/10/13 File\INV_S02_SOP for the preparation and maintenance of the TMF-ISF_V04.doc Page 1 of 7 Standard Operating Procedure for the Preparation and Maintenance of the Trial Master File (TMF) / Investigator Site

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

STANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders

STANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders STANDARD OPERATING PROCEDURE FOR RESEARCH Management of Essential Documents and Trial Folders Author Linda Ward Author s Job Title QA Coordinator Division Department Version number 2 Ref SOP/CLN/001/2

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

This document explains the main differences between two sets of performance metrics:

This document explains the main differences between two sets of performance metrics: Document Version 2.0 Date November 2013 The (70 day benchmark) and the NIHR Clinical Research Network High Level Objectives: a description of purpose, definition and differences Introduction This document

More information

The Health Research Authority. Janet Wisely. April 2015

The Health Research Authority. Janet Wisely. April 2015 The Health Research Authority Janet Wisely April 2015 The HRA as an organisation A Non-Departmental Public Body January 2015 Public sector employees on NHS terms Volunteer members of committees A Special

More information

Measures. SOP Number: UoA-NHSG-SOP-045 Version No: 1

Measures. SOP Number: UoA-NHSG-SOP-045 Version No: 1 Standard Operating Procedure: Management of Deviations, Breaches and Urgent Safety SOP Number: UoA-NHSG-SOP-045 Version No: 1 Author: Date: 27 th March 2015 (Patricia Burns, Research Governance Manager,

More information

The Study Site Master File and Essential Documents

The Study Site Master File and Essential Documents The Study Site Master File and Essential Documents Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 002 Version number: 1 Effective date: 01 June 2010

More information

This SOP may also be used by staff from other NHS areas, or organisations, with prior agreement.

This SOP may also be used by staff from other NHS areas, or organisations, with prior agreement. Standard Operating Procedure: SOP Number: SOP-QA-32 Version No: 1 Author: Date: (Gary Cooper, Named Sponsor Archivist, NHS Grampian and University of Aberdeen) 1-9-15 Approved by: Date: 1-9-15 (Professor

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

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

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

The Practicalities of Data Standards

The Practicalities of Data Standards The Practicalities of Data Standards Provided by Catherine Carpenter-Clawson, Research Network Manager For EDGE User Conference 2014 17 th March 2014 Contents Example 1: Local challenges with study arm

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

Guidance Document for HRA Statement of Activities for Participating NHS Organisations in England (version 4.1)

Guidance Document for HRA Statement of Activities for Participating NHS Organisations in England (version 4.1) Guidance Document for HRA Statement of Activities for Participating NHS Organisations in England (version 4.1) What is the HRA Statement of Activities? The Statement of Activities is part of the application

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

Research & Development Directorate

Research & Development Directorate Research & Development Directorate Type of Document Standard Operating Procedure Name SOP10: Routine Audit Version 3.0 Author Miss Jennifer Boyle (Research Governance Co-ordinator) Version Superseded 2.4

More information

Trial Delivery SOP 05 Trial Archiving

Trial Delivery SOP 05 Trial Archiving Gloucestershire Research and Development Consortium Standard Operating Procedure R&D SOP TD 05Trial Archiving Trial Delivery SOP 05 Trial Archiving IT IS THE RESPONSIBILITY OF ALL USERS OF THIS SOP TO

More information

SOP TD 01: Research Documentation and File Management

SOP TD 01: Research Documentation and File Management Gloucestershire Research and Development Consortium Standard Operating Procedure R&DSOP TD 01 Research Documentation and File Management SOP TD 01: Research Documentation and File Management IT IS THE

More information

Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. Lisa Austin, Research Manager

Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. Lisa Austin, Research Manager Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s Author: Lisa Austin, Research Manager Purpose and Objective: To identify and standardise

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

Essential Documentation and the Creation and Maintenance of Trial Master Files

Essential Documentation and the Creation and Maintenance of Trial Master Files This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document

More information

Site Initiation and Close Out (Sponsored Clinical Trials)

Site Initiation and Close Out (Sponsored Clinical Trials) Site Initiation and Close Out (Sponsored Clinical Trials) Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 008 Version number: 1 Effective date: 01 June

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

CONTROLLED DOCUMENT. Uncontrolled Copy. RDS014 Research Related Archiving. University Hospitals Birmingham NHS Foundation Trust

CONTROLLED DOCUMENT. Uncontrolled Copy. RDS014 Research Related Archiving. University Hospitals Birmingham NHS Foundation Trust University Hospitals Birmingham NHS Foundation Trust CONTROLLED DOCUMENT RDS014 Research Related Archiving CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Version Number: 1 Controlled Document

More information

Healthcare services requiring prior authorisation

Healthcare services requiring prior authorisation Annex 2 Healthcare requiring prior authorisation This list does not include organ transplants and does also not apply to long-term care and the primary purpose of which is to support people in need of

More information

Principle Investigator Training

Principle Investigator Training Principle Investigator Training January 2015, Southampton Dr Waquas Waheed CRN and The University of Manchester Outline Introduction to clinical trials in the UK Role of the networks Role of CSO Role of

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

LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE. Loughborough University (LU) Research Office

LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE. Loughborough University (LU) Research Office LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE Loughborough University (LU) Research Office SOP 1033 LU Process for Assessing Site Feasibility for NHS Research Sponsored by Loughborough

More information

Standard Operating Procedure for Archiving Essential Documentation relating to Clinical Trials of Investigational Medicinal Products (CTIMPs)

Standard Operating Procedure for Archiving Essential Documentation relating to Clinical Trials of Investigational Medicinal Products (CTIMPs) archiving\spon_s21_sop_for_archiving V02.doc Page 1 of 13 Standard Operating Procedure for Archiving Essential Documentation relating to Clinical Trials of Investigational Medicinal Products (CTIMPs) SOP

More information

Protocol Deviations, Non-Compliance and Serious Breaches

Protocol Deviations, Non-Compliance and Serious Breaches Protocol Deviations, Non-Compliance Clinical Trials SOP Reference ID: Noclor/Spon/S10/01 Version Number 1.0 Effective Date: 1 st March 2016 It is the responsibility of all users of this SOP to ensure that

More information

Research Study Close-down and Archiving Procedures

Research Study Close-down and Archiving Procedures Title: Outcome Statement: Research Study Close-down and Archiving Procedures To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust.

More information

Section 5 onwards provides information aimed at researchers who are interested in working with us.

Section 5 onwards provides information aimed at researchers who are interested in working with us. NORWICH CLINICAL TRIALS UNIT This document provides an overview of the Norwich Clinical Trials Unit: Sections 1 to 3 describe the Norwich Clinical Trials Unit remit and structure for our stakeholders and

More information

MHRA GCP Inspection No: INSP GCP 13605/19486-0003 - Corrective And Preventative Action Plan (CAPA)

MHRA GCP Inspection No: INSP GCP 13605/19486-0003 - Corrective And Preventative Action Plan (CAPA) Finding Number Sponsor Site Findings Finding Class: 1.0 Data Integrity CRITICAL 1.1 1.1.1 All clinical information shall be recorded, handled and stored in such a way that it can be accurately reported,

More information

R&D Administration Manager. Research and Development. Research and Development

R&D Administration Manager. Research and Development. Research and Development Document Title: Document Number: Patient Recruitment SOP031 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration Manager,

More information

JOINT RESEARCH AND DEVELOPMENT OFFICE. Standard Operating Procedure for Investigators and the Joint R&D Office Staff SOP 22

JOINT RESEARCH AND DEVELOPMENT OFFICE. Standard Operating Procedure for Investigators and the Joint R&D Office Staff SOP 22 JOINT RESEARCH AND DEVELOPMENT OFFICE Standard Operating Procedure for Investigators and the Joint R&D Office Staff SOP 22 Updated By Praseeda Thaikalloor Clinical trials Manager Joint R&D office for GOSH/ICH

More information

Archiving of Clinical Trial Data and Essential Documentation JCTO/CT/SOP 4.0. Joint Clinical Trials Office. Stuart Hatcher, JCTO Archivist

Archiving of Clinical Trial Data and Essential Documentation JCTO/CT/SOP 4.0. Joint Clinical Trials Office. Stuart Hatcher, JCTO Archivist Archiving of Clinical Trial Data and Essential Documentation Policy Details Document Type Standard Operating Procedure Document name Change History Date Version Number JCTO/CT/SOP 4.0 Version Final v 2.0-09/11/2010

More information

Working Instruction Template. Instructions for Archiving of Essential Trial Documents at Datatron Off Site Facility

Working Instruction Template. Instructions for Archiving of Essential Trial Documents at Datatron Off Site Facility Working Instruction Template WI number: WI full title: WI-JRO-001 Instructions for Archiving of Essential Trial Documents at Datatron Off Site Facility WI effective: 28 th October 2013 Review date: 28

More information

Attributing the costs of health and social care Research & Development (AcoRD)

Attributing the costs of health and social care Research & Development (AcoRD) Frequently Asked Questions Annex B Q1. Why have you revised the guidance on attributing Research Costs, Support Costs and Treatments Cost in the NHS? A. The definitions of Research Costs, NHS Support Costs

More information

Workstream 4: Trial Management and Monitoring: B) Summary of Trial Management Systems (TMS)

Workstream 4: Trial Management and Monitoring: B) Summary of Trial Management Systems (TMS) Trial Management Workstream 4: Trial Management and Monitoring: B) Summary of Trial Management Systems (TMS) Trial management is the process of ensuring that a trial is run effectively and within budget.

More information

Prerequisite. Course Delivery. ACHI and ACS CLINICAL CODING COURSE INFORMATION

Prerequisite. Course Delivery. ACHI and ACS CLINICAL CODING COURSE INFORMATION Advanced ICD-10-AM ACHI and ACS CLINICAL CODING COURSE INFORMATION Advanced ICD-10-AM, ACHI and ACS will be of value to coders who already have significant experience in clinical coding and who wish to

More information

NORWICH CLINICAL TRIALS UNIT OVERVIEW

NORWICH CLINICAL TRIALS UNIT OVERVIEW NORWICH CLINICAL TRIALS UNIT OVERVIEW This document provides an overview of the Norwich Clinical Trials Unit. Sections 1 to 3 describe the Norwich Clinical Trials Unit remit and structure. Section 4 gives

More information

The Royal Wolverhampton NHS Trust

The Royal Wolverhampton NHS Trust The Royal Wolverhampton NHS Trust Trust Board Report Meeting Date: 23 rd February 2015 Title: National Institute for Health Research Clinical Research Network: West Midlands Annual Plan submission 2015-16

More information

CLINICAL STUDIES GUIDELINE FUNDING APPLICATION

CLINICAL STUDIES GUIDELINE FUNDING APPLICATION CLINICAL STUDIES GUIDELINE FUNDING APPLICATION Applications for Full Study Funding (over 30,000)... 2 Applications for Pilot / Feasibility Funding (Under 30,000)... 2 Applications for Virements (movement

More information

PRACTICE INFORMATION SHEET

PRACTICE INFORMATION SHEET PRACTICE INFORMATION SHEET Study title A feasibility study for a cluster randomised trial of text messaging reminders for influenza vaccine in patients under 65 in clinical risk groups in English primary

More information

Q1. Why have you revised the guidance on attributing Research Costs, Support Costs and Treatments Cost in the NHS?

Q1. Why have you revised the guidance on attributing Research Costs, Support Costs and Treatments Cost in the NHS? Annex B Frequently Asked Questions Updated May 2015 Q1. Why have you revised the guidance on attributing Research Costs, Support Costs and Treatments Cost in the NHS? A. The definitions of Research Costs,

More information

Document Number: SOP/RAD/SEHSCT/007 Page 1 of 17 Version 2.0

Document Number: SOP/RAD/SEHSCT/007 Page 1 of 17 Version 2.0 Standard Operating Procedures (SOPs) Research and Development Office Title of SOP: Computerised Systems for Clinical Trials SOP Number: 7 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013

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

Attributing the costs of health and social care Research & Development (AcoRD)

Attributing the costs of health and social care Research & Development (AcoRD) Frequently Asked Questions Updated December 2015 Annex B Contents 1. Introduction... 2 2. Funding sources... 2 3. Clinical Research Network funding... 5 4. Application advice services/nhs permissions...

More information

DATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS

DATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS Reference Number: UHB 139 Version Number: 2 Date of Next Review: 14 Apr 2018 Previous Trust/LHB Reference Number: N/A DATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS Introduction and Aim

More information

UK Implementation of the EU Clinical Trial Directive 2001/20/EC:

UK Implementation of the EU Clinical Trial Directive 2001/20/EC: UK Implementation of the EU Clinical Trial Directive 2001/20/EC: GCP Aspects. Dr. Colin Wilsher, FRQA. BARQA GCP Committee Chairman; & Pfizer Worldwide Development Quality Assurance. GIQAR, Roma, October

More information

Issue date: October 2009. Guide to the single technology appraisal process

Issue date: October 2009. Guide to the single technology appraisal process Issue date: October 2009 Guide to the single technology appraisal process Guide to the single technology appraisal process Issued: October 2009 This document is one of a series describing the processes

More information

CENTRAL MANCHESTER UNIVERSITY HOSPITALS NHS FOUNDATION TRUST

CENTRAL MANCHESTER UNIVERSITY HOSPITALS NHS FOUNDATION TRUST CENTRAL MANCHESTER UNIVERSITY HOSPITALS NHS FOUNDATION TRUST Agenda Item 9.3 Report of: Paper prepared by: Robert Pearson Medical Director, CMFT Lisa Miles Senior Project Manager, Research & Innovation

More information

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare

More information

OxB01 v1.00. R&D Operational Capability Statement

OxB01 v1.00. R&D Operational Capability Statement OxB01 v1.00 R&D Operational Capability Statement Version History Version number Valid from Valid to Date approved Approved by Updated by OxB01 v1.00 03/03/2011 02/03/2013 03/03/2011 Board of Directors

More information

Points to consider when assessing the feasibility of research

Points to consider when assessing the feasibility of research Points to consider when assessing the feasibility of research Prepared by the: Association of Medical Research Charities (AMRC) and NIHR Medicines for Children Research Network (MCRN) The Medicines for

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

Clinical Research Induction Pack for Nurses, Midwives and other Allied Health Professionals

Clinical Research Induction Pack for Nurses, Midwives and other Allied Health Professionals Clinical Research Induction Pack for Nurses, Midwives and other Allied Health Professionals Leeds Teaching Hospitals NHS Trust & University of Leeds Name... Job Title... Start Date... Line Manager... 1

More information

Does my project require review by a Research Ethics Committee?

Does my project require review by a Research Ethics Committee? National Research Ethics Service Does my project require review by a Research Ethics Committee? This algorithm is designed to assist researchers, sponsors and R&D offices in determining whether a project

More information

Procedure for Non-Medical Staff who wish to Request MRI, Ultrasound and Imaging Examinations under IR(ME)R

Procedure for Non-Medical Staff who wish to Request MRI, Ultrasound and Imaging Examinations under IR(ME)R Procedure for Non-Medical Staff who wish to Request MRI, Ultrasound and Imaging V3.0 December 2013 Page 1 of 11 Table of Contents 1. Introduction... 3 2. Purpose of this Policy/Procedure... 3 3. Scope...

More information

Management of Protocol Deviations, Violations and Urgent Safety Measures

Management of Protocol Deviations, Violations and Urgent Safety Measures This is a controlled document. The master document is posted on the JRO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document

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

Clinical Research in Mauritius

Clinical Research in Mauritius BOARD OF INVESTMENT Clinical Research in Mauritius This document provides an informative summary of the procedure to apply for a clinical research protocol in Mauritius. Contents INTRODUCTION... 2 I. APPLICATION

More information

Annual Plan 2015-16 1

Annual Plan 2015-16 1 Annual Plan 2015-16 1 CRN: [North East and North Cumbria] Annual Plan 2015-16 Contents Table 1 LCRN plans and goals for contributing to NIHR CRN High Level Objectives 2015-16 p.1 Table 2 LCRN plans to

More information

Job Profile Clinical Research Associate III (CRA)

Job Profile Clinical Research Associate III (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

TEMPLATE DATA MANAGEMENT PLAN

TEMPLATE DATA MANAGEMENT PLAN TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager

More information

Sheffield Clinical Trials Research Unit. Cindy Cooper Director, Sheffield CTRU

Sheffield Clinical Trials Research Unit. Cindy Cooper Director, Sheffield CTRU Sheffield Clinical Trials Research Unit Cindy Cooper Director, Sheffield CTRU How do we differ from RDS? Research Design Service Assistance with design (portfolio studies): Clinical Trials Research Unit

More information

A Guide to Efficient Trial Management. Trials Managers Network

A Guide to Efficient Trial Management. Trials Managers Network A Guide to Efficient Trial Management Trials Managers Network The Fourth Edition (2014) of the Guide to Efficient Trial Management was produced by an appointed Editorial Board and a dedicated group of

More information

A Guide to Pharmacy Documentation For Clinical Trials

A Guide to Pharmacy Documentation For Clinical Trials A Guide to Pharmacy Documentation For Clinical Trials Roy Sinclair Clinical Trials Pharmacist St. George s Hospital (to Sep 2007) Lecturer Kingston University January 2008 A Guide to Pharmacy Documentation

More information

INCOME DISTRIBUTION FROM NIHR ADOPTED INDUSTRY SPONSORED STUDIES

INCOME DISTRIBUTION FROM NIHR ADOPTED INDUSTRY SPONSORED STUDIES Title: Outcome Statement: INCOME DISTRIBUTION FROM NIHR ADOPTED INDUSTRY SPONSORED STUDIES To ensure that income distribution from work undertaken within the Trust for National Institute for Health (NIHR)-adopted

More information

Clinical Trial Operations

Clinical Trial Operations Contract Research and Consulting Organisation Consulting Clinical Trial Operations Training Your partner for CLINically remarkable results We are a leading Polish company specializing in clinical research

More information

GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL

GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL Table of Contents A. Legal requirement... 1 B. Purpose of the requirement... 1 C. Purpose of this guidance... 2 D. Arrangements

More information

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015

Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient

More information

PRIVATE HOSPITAL INFORMATION FORM

PRIVATE HOSPITAL INFORMATION FORM PRIVATE HOSPITAL INFORMATION FORM Instructions This application form is designed to be completed electronically and then emailed as an attachment. Complete the form by entering the information in the fields

More information

Guidance linked to the model Industry Collaborative Research Agreement (micra)

Guidance linked to the model Industry Collaborative Research Agreement (micra) GUIDANCE RELATING TO THE MODEL AGREEMENT FOR COLLABORATIVE COMMERCIAL CLINICAL RESEARCH CONDUCTED BY COMPANIES IN THE PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRIES IN ASSOCIATION WITH UNIVERSITIES AND NHS

More information

CRN: South London Funding Model

CRN: South London Funding Model Summary of Partnership Group Agreement to Clinical Research Network: South London Funding Model Proposal 1. Introduction The Clinical Research Network: South London (CRN: South London) was formed in April

More information

Investigator Responsibilities

Investigator Responsibilities Investigator Responsibilities Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 010 Version number: 1 Effective date: 01 June 2010 Review due: May 2011

More information