ETHICS, IRAS & DATA PROTECTION
|
|
|
- Clinton Lloyd
- 5 years ago
- Views:
Transcription
1 ETHICS, IRAS & DATA PROTECTION Clinical Research Methods Course 14 th March 2017 Priyanthi Dias Senior Trials Coordinator Adult CriDcal Care Research Unit Queen Mary University of London
2 DefiniDons CI: Chief InvesDgator CTIMP: Clinical Trial of an InvesDgaDonal Medicinal Product IRAS: Integrated Research ApplicaDons system MHRA: Medicines and Healthcare products Regulatory Agency HRA: Health Research Authority REC: Research Ethics CommiSee CRN: Clinical Research Network
3 Who are the main organisadons? HRA/ REC PaDents MHRA Sponsor Sites CRN CI
4 Clinical trial pathway h"p:// toolkit.ac.uk/routemap/
5 Clinical trial pathway h"p:// toolkit.ac.uk/routemap/
6 Where do I start? StaDsDcian Trial Documents Protocol IRAS PaDent InformaDon Sheet Informed Consent GP leser Funding Contracts Collaborators CI Trial Manager/ Coordinator QA Manager Database Manager Sponsor
7 Is Your Study Ethical? Consent Form(s) PaDent InformaDon Sheet Study protocol
8 Ethics applicadon Part 1 Peer reports/ Risk assessments Local Peer Review Trial documents Sponsor Trial team
9 Integrated Research ApplicaDon System (IRAS) Standardised pla_orm for Permissions & Approvals for UK Health Research Register for an IRAS account (hsps:// Create a new project Transcribe study protocol into Project document Provide further clarificahon around study procedures & ethical considerahons Single system for approvals for research in the UK Depending on the type of study, uses filters to ensure the appropriate informahon is collected Add parhcipahng sites and the principal inveshgators
10 IRAS - RegistraDon hsps://
11 IRAS Create New Project hsps://
12 IRAS Core Study QuesDons
13 IRAS Project filter quesdons non- CTIMP
14 IRAS Project filter quesdons CTIMP C
15 IRAS Project filter quesdons CTIMP C CTIMPS need to be registered on EudraCT (ISRCTN for non- CTIMPS) Clinical Trial ApplicaHon Form needs to be completed Provide further informahon on the - InvesHgaHonal Medicinal Products (IMPs) - Placebos if required (h"ps://eudract.ema.europa.eu/eudract- web/index.faces)
16 IRAS Project filter quesdons CTIMP
17 IRAS Check List CTIMPS only
18 Provisional Sponsorship Document check list Provisional Sponsorship and Indemnity h"p://bartshealth.nhs.uk/research/strategy- and- policy/standard- operahng- procedures/
19 IRAS Electronic AuthorisaDons Book meedng with the REC Submission can be made only ader electronic authorisadons If you change any informadon ader authorisadons, signatures will need to be requested again
20 IRAS NIHR Por_olio AdopDon Studies funded as a result of open compeddon in England with high quality peer review Research that is of clear value to the NHS Studies that take appropriate account of the priorides, needs and realides of the NHS hsp:// and- impact/nihr- clinical- research- network- por_olio/
21 REC/HRA Approvals Pathway
22 Capacity and Capability
23 Approvals Checklist REC Favourable opinion LeSer of HRA approval NIHR Por_olio adopdon ConfirmaDon of Capacity and Capability Full Sponsorship
24 IRAS - Amendments
25 Data ProtecDon Act 1998
26 Importance of Consent in Data CollecDon
27 Sharing of Study Materials Study Protocol PIS & Consent Forms Consent logs CRF Study PaDent Data Tissue Local Stores Centralised Repositories
28 Summary YOU NEED CONSENT AND ETHICAL APPROVAL FOR YOUR MATERIALS Partner the Sponsor when seeking ethical approvals for your studies Use DEIDEINTIFIED MATERIALS wherever possible Create applicadon PDFs using IRAS: New projects One system to apply for all the required approvals Changing the study (SubstanDal Amendments) Implement robust documents to protect your study materials: Standardised SOPs (Study protocol, Database, Biobank) Data Usage Agreements (DUA) / Materials Transfer Agreements (MTA)
29 QUESTIONS?
Research Study Amendments
REFERENCE: VERSION NUMBER: 3.2 EFFECTIVE DATE: 05-02-18 REVIEW DATE: 05-02-20 AUTHOR: Clinical Trials Manager; Clinical Trials Officer REVIEWED BY: R&I Senior Team APPROVED BY: Deputy Director of Research
STANDARD OPERATING PROCEDURE FOR RESEARCH. 14. Amendments to Research Studies
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 14. Amendments to Research Studies Amendments are changes made
UK COMPATIBILITY HEALTH RESEARCH AUTHORITY APPROVAL WHAT IS HEALTH RESEARCH AUTHORITY APPROVAL?
UK COMPATIBILITY HEALTH RESEARCH AUTHORITY APPROVAL WHAT IS HEALTH RESEARCH AUTHORITY APPROVAL? Health Research Authority (HRA) Approval is a new process for the NHS in England that assesses a research
Sally Burtles, Director of Research Services & Business Development
Standard Operating Procedures (SOP) for: Process for Researchers - Amendments for Sponsored Studies (including halting studies and early termination) SOP Number: 17c Version Number: 2.0 Effective Date:
Once notified of the end of trial, a Research Manager, on behalf of the Sponsor, will contact the CI to arrange a close down monitoring visit.
1. INTRODUCTION This SOP has been produced in accordance with the requirements of The Medicines for Human Use (Clinical Trials) Regulations 2004, Medicines for Human Use (Clinical Trials) Amendment Regulations
Investigator Site File Index (CTIMP)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol Current version plus all previous versions (or provide file note to detail location of previous
STUDY DOCUMENTS. DOCUMENT NO.: CR007 v4.0. Marise Buçukoğlu ISSUE DATE: 07 MAR 2017 EFFECTIVE DATE: 21 MAR INTRODUCTION
STUDY DOCUMENTS DOCUMENT NO.: CR007 v4.0 AUTHOR: Marise Buçukoğlu ISSUE DATE: 07 MAR 2017 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint office
STANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number End of Study Notification and Premature Discontinuation of a Study SOP-RES-025 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016
Setting up new studies where NBT are sponsor
Setting up new studies where NBT are sponsor Task Why Task Should Happen When Task Should Happen Who Should Complete Task How Task is Completed TASK 1: Apply for confirmation that NBT can sponsor the study
Investigator Site File Index (Medical Devices)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol (Clinical Investigation Plan) Current version plus all previous versions (or provide file note
Research & Development. J Illingworth and S Moffat. Research, pharmacy and R&D staff
Department Title of SOP Research & Development SOP reference no: R&D GCP SOP 08 Authors: Reviewed by Current version number and date: J H Pacynko J Illingworth and S Moffat Version 4, 04.02.19 Next review
Trial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products
1 Trial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products SECTION TITLE DOCUMENTS 1. Contact List Including details of relevant study site staff, responsible
End of Study Notification, Close-Out and Reporting Sponsored Research. Noclor/Spon/S11/01. SOP Reference ID:
End of Study Notification, Close-Out and Sponsored Research SOP Reference ID: Noclor/Spon/S11/01 Version Number 1.0 Effective Date: 6 th June 2016 It is the responsibility of all users of this SOP to ensure
Index of Standard Operating Procedures for all research Sponsored by the UHL
University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the March Please note that with effect from 2015, all SOPs and Appendices use the same
SPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT
SPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT DOCUMENT NO.: GS010 v1.0 AUTHOR: Vikki Young ISSUE DATE: 28 MAY 2018 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research &
Standard Operating Procedure
Standard Operating Procedure Number: UM/UoM TMF/SOP08/6.0 Title: The Creation and Maintenance of Trial Master Files and Essential Documentation Version: 6.0 () Effective Date: Author: Mrs Catherine Barrow
Phase 1 studies and The Over- Volunteering Prevention System (TOPS)
Research Department STANDARD OPERATING PROCEDURE Phase 1 studies and The Over- Volunteering Prevention System () SOP Number C129 Version Number 1.0 Date effective 18 June 2018 Author Luke Barron Related
Marie-Claire Good, RG and GCP Manager James Rickard, Deputy Chief Pharmacist Technical Services Cheryl Lawrence, Senior Research Pharmacist
Standard Operating Procedures (SOP) for: IMP Management BH/QMUL Sponsored CTIMPs SOP Number: 42a Version Number: 3.0 Effective Date: 14 th August 2017 Review Date: 14 th August 2019 Author: Reviewer: Reviewer:
The Pathway of Project Approvals. Charlotte Davies- Research and Development Operations Manager
The Pathway of Project Approvals Charlotte Davies- Research and Development Operations Manager What do R&D do? Advises on relevant regulations and legislation Advises on planning and conduct of research
Index of Standard Operating Procedures for all research Sponsored by the UHL
University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the October Please note that with effect from 2015, all SOPs and Appendices use the same
Louise Brook Clinical Trials Quality Monitor. Date
Details: Author: Louise Brook Clinical Trials Quality Monitor SOP Pages: 12 Version No. of replaced SOP: Effective date of replaced SOP: NA NA Approval: Version No: of the SOP being approved. Name of person
MHRA regulatory centre and Research Ethics Service (RES) combined ways of working pilot Instructions to sponsors (version 2.1)
MHRA regulatory centre and Research Ethics Service (RES) combined ways of working pilot Instructions to sponsors (version 2.1) Document purpose: The purpose of this document is to provide instructions
Standard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies. SOP Number: SOP-QA-9 Version No: 1
Standard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies SOP Number: SOP-QA-9 Version No: 1 Author: Date: 1-9-15 (Carole Edwards, Lead Research Nurse, NHS Grampian)
STANDARD OPERATING PROCEDURE SOP 310
STANDARD OPERATING PROCEDURE SOP 310 DEVELOPMENT OF PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM Version 1.3 Version date 28.03.2017 Effective date 28.03.2017 Number of pages 8 Review date April
RD SOP32 Gaining MHRA Approval
RD SOP32 Gaining MHRA Approval Version Number: 1.0 Name of originator/author: Dr Lloyd Gregory Name of responsible committee: R&I Committee Name of executive lead: Medical Director & Director of Quality
Standard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies. SOP Number: UoA-NHSG-SOP-010 Version No: 2
Standard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies SOP Number: UoA-NHSG-SOP-010 Version No: 2 Author: Date: 27 th March 2015 (Carole Edwards, Lead Research
Date: 23 rd December 2014 Version 5 Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03)
Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03) Approvals Principal Author Name: D. Skelhorn Signature: D. Skelhorn Date: 22/12/2014 Quality Assurance Officer
Writing a Protocol for CTIMPs
REFERENCE: VERSION NUMBER: 4.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: REVIEWED BY: APPROVED BY: CONTROLLER: Clinical Trials Manager; Clinical Trials Officer Research & Innovation Group
How to Apply for Ethics (Non-CTIMPs) including Sponsorship
How to Apply for Ethics (Non-CTIMPs) including Sponsorship Joint Research & Enterprise Office (JREO) St George s University of London Lucy H H Parker Clinical Research Governance Manager Joint Research
Conducting Clinical Trials of Investigational Medicinal Products
Title: Outcome Statement: Written By: Reviewed By: Conducting Clinical Trials of Investigational Medicinal Products Researchers in the Trust and research partners will be informed about the procedures
Trial Committees SOP Number: 47 Version Number: 2.0 Effective Date: 01/02/2017 Review Date: 01/02/2019
Standard Operating Procedures (SOP) for: Trial Committees SOP Number: 47 Version Number: 2.0 Effective Date: 01/02/2017 Review Date: 01/02/2019 Author: Reviewer: Reviewer: Authorisation: Name / Position:
Code break is also known as breaking the blind and involves un-blinding a participant so that the treatment allocation is made known.
1. INTRODUCTION This SOP has been produced in accordance with Medicines for Human Use (Clinical Trials) Regulations 2004. This SOP will outline the procedure for breaking the study code in a NUH sponsored
HRA/Ethics Approval for Health-Related Research
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
IMP Management and Accountability
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
RESEARCH AUDIT Standard Operating Procedure
Reference Number: UHB 236 Version Number: 2 Date of Next Review: 17 th Oct 2020 Previous Trust/LHB Reference Number: N/A RESEARCH AUDIT Standard Operating Procedure Introduction and Aim As a legal Sponsor
Pharmacovigilance and safety reporting for sponsored ATIMPs/CTIMPs
Joint Research Management Office (JRMO) Standard Operating Procedure (SOP) for: Pharmacovigilance and safety reporting for sponsored ATIMPs/CTIMPs SOP Number: 26a Version Number: 13.0 Effective Date: 31
STANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Maintaining Study Files SOP-RES-014 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s)
Research Governance Policy and Procedure
Research Governance Policy and Procedure Version: 5 Name of originator/author: Name of executive lead: Date ratified: Review date: APPLICABLE TO: All staff. EXECUTIVE SUMMARY Dr Lisa Austin- University
STANDARD OPERATING PROCEDURE FOR RESEARCH. 17. Study Close Down
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 17. Study Close Down According to ICH Good Clinical Practice (GCP)
STUDY CLOSURE AND ARCHIVING
STUDY CLOSURE AND ARCHIVING DOCUMENT NO.: CR009 v2.0 AUTHOR: Lynn Smith ISSUE DATE: 15 August 2016 EFFECTIVE DATE: 29 August 2016 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research
Date: 21 st May 2014 Version: 5 Page 1 of 11. Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May 2014
Date: 21 st May 2014 Version: 5 Page 1 of 11 STANDARD OPERATING PROCEDURE FOR MONITORING CLINICAL TRIALS (NWORTH 3.07) Approvals Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May
STANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Training and Development SOP-QMS-007 Version Number 2 Issue Date 15 Apr 2016 Effective Date 26 May 2016 Review Date 26 May 2018 Author(s) Reviewer(s)
STANDARD OPERATING PROCEDURE SOP 410. Set up and Initiation of an Investigator Site
STANDARD OPERATING PROCEDURE SOP 410 Set up and Initiation of an Investigator Site Version 1.2 Version date 4.01.2017 Effective date 5.07.2017 Number of pages 13 Review date July 2019 Author Role NNUH
SOP14a: Standard Operating Procedure Applying for Ethical Approval
SOP14a: Standard Operating Procedure Applying for Ethical Approval Authorship Team: Jemma Hughes for Joint SOP Group on Trial Processes (viz Leanne Quinn, Ian Russell, Anne Seagrove, John Williams, Bridget
STANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Non Compliance and Serious Breach Reporting SOP-RES-017 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov
PERFORMANCE IN INITIATING CLINICAL RESEARCH (PI) CLINICAL TRIAL FEEDBACK PROCESS HRA APPROVED TRIALS
PERFORMANCE IN INITIATING CLINICAL RESEARCH (PI) CLINICAL TRIAL FEEDBACK PROCESS HRA APPROVED TRIALS Version Control New document 1 Acronyms CTP DSC DSS FPR HRA MHRA REC SOP Clinical Trial Performance
COMBINED RISK ASSESSMENT
COMBINED RISK ASSESSMENT DOCUMENT NO.: GS002 v3.0 AUTHOR: Lorn Mackenzie ISSUE DATE: 04 AUG 2017 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint
Scotland A REC 2 nd Floor Waverley Gate 2-4 Waterloo Place Edinburgh EH1 3EG
Scotland A REC 2 nd Floor Waverley Gate 2-4 Waterloo Place Edinburgh EH1 3EG Telephone: 0131-465-5679 19 February 2016 Professor Karim Brohi Professor of Trauma Science Queen Mary University of London
RDSOP28 Randomisation and Unblinding in Clinical Trials of an Investigational Medicinal Product (CTIMPs)
RDSOP28 Randomisation and Unblinding in Clinical Trials of an Investigational Medicinal Greater Manchester Mental Health NHS Foundation Trust Title of Standard Operating Procedure: Document Summary: Document
Combined trial of an investigational medicinal product and an investigational medical device
Welcome to the Integrated Research Application System IRAS Project Filter The integrated dataset required for your project will be created from the answers you give to the following questions. The system
LCRN Guidance Suite. V1.0 March Document Ref No: D05. Version 1.0 March 2016 Page 1 of 8
LCRN Guidance Suite Provision of good practice for Sponsors to enable assesing, arranging and confirming local capacity and capability for participating organisations delivering CRN Portfolio studies V1.0
Marie-Claire Rickard, RG and GCP Manager Cheryl Lawrence, Senior Research Pharmacist Damien Kelly, Barts Pharmacy Site and Clinical Trials Lead
Standard Operating Procedures (SOP) for: Pharmacy Involvement in Hosted Studies SOP Number: 42b Version Number: 2.0 Effective Date: 23 rd November 2015 Review Date: 2 nd November 2017 Author: Reviewer:
Standard Operating Procedure Research Governance
Research and Enterprise Standard Operating Procedure Research Governance Title: Termination or Suspension of a Research Study SOP Reference Number: QUB-ADRE-020 Date prepared 13 August 2008 Version Number:
RESEARCH IN HUMAN SUBJECTS OTHER THAN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS
Page 1 of 5 RESEARCH IN HUMAN SUBJECTS OTHER THAN CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS After ethical review guidance for sponsors and investigators This document sets out important guidance
PERFORMANCE IN INITIATING AND DELIVERING CLINICAL RESEARCH INFORMATION SUBMISSION GUIDELINES
PERFORMANCE IN INITIATING AND DELIVERING CLINICAL RESEARCH INFORMATION SUBMISSION GUIDELINES Version Control Item 19 Items 25, 26 Item 29 Update to the Publication requirements Update of Submission Timetable
Standard Operating Procedure for Archiving
Standard Operating Procedure for Archiving SOP name: NWORTH07/19 archiving Version 2 Authorship Team: Angela Gliddon & Rhiannon Whitaker Meeting date reviewed 16 th April 2008 Designated NWORTH member
Standard Operating Procedure. Vendor Management
REFERENCE: VERSION NUMBER: 2.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Clinical Trials Manager, Contracts & Quality Management Officer REVIEWED BY: Research & Innovation Group APPROVED BY:
Joint Research Office
Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Tel: 020 3447 5557 Fax: 020 3447 9937 Website: www.uclh.nhs.uk; www.ucl.ac.uk; www.ucl.ac.uk/jro Postal
QUEEN S UNIVERSITY BELFAST. Regulations for Research Involving Human Participants
QUEEN S UNIVERSITY BELFAST Regulations for Research Involving Human Participants 1. Introduction Research involving human participants falls into a different category from other research carried out within
Comparison of admission rates to neonatal units between PO screening and non-po screening Units
London - Westminster Research Ethics Committee 4 Minshull Street Manchester M1 3DZ Telephone: 0207 104 8012 Please note: This is the favourable opinion of the REC only and does not allow you to start your
Ethical Approval. Document Number: 012
Ethical Approval Document Number: 012 Version: 1 Ratified by: RFL Committee Date ratified: 03.06.2014 Name of originator/author: Directorate: Department: Name of responsible individual: Liba Stones, Manager
NRES Committee East of England - Cambridge Central Royal Standard Place Nottingham NG1 6FS
22 April 2015 NRES Committee East of England - Cambridge Central Royal Standard Place Nottingham NG1 6FS Professor Willem Ouwehand Wellcome Trust Sanger Institute, Honorary NHSBT Consultant in Haematology.
Document Title: Site Recruitment and Initiation for Papworth Sponsored Studies
Document Title: Site Recruitment and Initiation for Papworth Sponsored Studies Document Number: SOP015 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For
STANDARD OPERATING PROCEDURE SOP 320. Developing a Research Protocol
STANDARD OPERATING PROCEDURE SOP 320 Developing a Research Protocol Version 2.1 Version date 26.03.2017 Effective date 26.03.2017 Number of pages 14 Review date April 2019 Author NNUH UEA Joint Research
Confirming Research Study Capacity and Capability
Title: Outcome Statement: Written By: Confirming Research Study Capacity and Capability Researchers will be informed about the procedures and requirements for obtaining permission to conduct a research
Details: Approval: Distribution & Storage:
Details: Author: Neville Young Quality Assurance Manager SOP Pages: Version No. of replaced SOP: Effective date of replaced SOP: NA NA Approval: Version No: of the SOP being approved. Name of person approving
UK wide consistency and IRAS developments
UK wide consistency and IRAS developments Mary Cubitt Four Nations NHS/HSC Compatibility Programme Manager Operational Leads England, Northern Ireland, Scotland and Wales Four Nations Policy Group Commitment
Marie-Claire Rickard (RG and GCP Manager) Rachel Fay (RG and GCP Manager) Elizabeth Clough (R&D Governance Operations Manager)
Standard Operating Procedures (SOP) for: For researchers: Pharmacovigilance and Safety Reporting for Sponsored CTIMPs/ATMP SOP Number: 026a Version Number: 12.0 Effective Date: 21/4/16 Review Date: 21/4/18
R&D Administration Manager. Research and Development. Research and Development. NHS Staff Trust-Wide THIS IS A CONTROLLED DOCUMENT
Document Title: Document Number: Research Protocol Design for Papworth Sponsored Studies SOP019 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by:
Standard Operating Procedure (SOP) for the Development, Management & Control of Research-Related SOPs
Standard Operating Procedure (SOP) for the Development, Management & Control of Research-Related SOPs For Completion by SOP Author Reference Number Version Document Author(s) Document Reviewer(s) PHT/RDSOP/001
A step by step guide to using IRAS to apply to conduct research in or through the NHS/HSC.
A step by step guide to using IRAS to apply to conduct research in or through the NHS/HSC. 28 June 2017 Summary All project-based research conducted in or through the NHS/HSC in England, Northern Ireland,
ESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL
ESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL THIS INFORMATION SHEET (ISR-RG-014) HAS BEEN TAKEN DIRECTLY FROM THE ICH- GUIDELINE* WITH ADDITIONAL COMMENTS ADDED BY THE RESEARCH GOVERNANCE
Sponsorship of Clinical Research Studies
Sponsorship of Clinical Research Studies Category: Summary: Equality Impact Assessment undertaken: Policy The UK Policy Framework for Health and Social Care 2017 (UKPF) and The Medicines for Human Use
Research Study Close-down and Archiving Procedures
Title: Research Study Close-down and Archiving Procedures Outcome Statement: To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust.
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility Document Detail Document type Standard Operating Procedure CRF-STU-SOP-1: Management and Accountability
APPLICANT'S CHECKLIST
APPLICANT'S CHECKLIST Research tissue bank (or other research biobank) REC Ref: Title of Tissue Bank: Applicant's Name: Name of Designated Individual: Please complete this checklist and send it with your
The role of the Clinical Trials Unit Emma Hall PhD CStat Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
in partnership with The role of the Clinical Trials Unit Emma Hall PhD CStat Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU) CTRad Clinical Trials Workshop 14/10/2014 What is
RDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs. Greater Manchester Mental Health NHS Foundation Trust
RDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs Greater Manchester Mental Health NHS Foundation Trust Title of Standard Operating Procedure: RDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility Document Detail Document type Standard Operating Procedure CRF-STU-SOP-1: Management and Accountability
Writing a Protocol to Good Clinical Practice (GCP)
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
UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH SUPPORT OFFICE
UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL) Research Governance
STANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Archiving and the Destruction of Records SOP-RES-028 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January
Research Governance Policy
Research Governance Policy Version: Status: Title of originator/author: Name of responsible director: Developed/revised by group/committee and Date: Approved by group/committee and Date: Effective date
Recording, Managing and Reporting Adverse Events in the UK
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
Investigational Medicinal Product (IMP) Management Standard Operating Procedure
Reference Number: UHB 040 Version Number: 3 Date of Next Review: 26 Apr 2019 Previous Trust/LHB Reference Number: T 363 Standard Operating Procedure Introduction and Aim This procedure is written to support
Standard Operating Procedures (SOP) Research and Development Office
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Essential Documentation and Creation and Maintenance of Trial Master File SOP Number: 13 Version Number: 2.0 Supercedes:
JOB DESCRIPTION. Position Number various. Job Title Trial Manager. Academic / Service Unit Newcastle Clinical Trials Unit. Effective Date
Job Title Trial Manager Academic / Service Unit Newcastle Clinical Trials Unit Position Number various Effective Date 01.04.2018 Faculty / Central Services Faculty of Medical Sciences Grade F Vacancy Ref
George E. Griffin PhD, FRCP, F Med Sci Professor of Medicine and Infectious Diseases. Amsterdam, Jan. 2010
Good Clinical Practice Guidelines and the European Directive. How Can Investigator-initiated Research Survive? Current UK Situation-Academic Perspective. George E. Griffin PhD, FRCP, F Med Sci Professor
Document Title: Handling of drug alerts and recalls of IMPs
Document Title: Handling of drug alerts and recalls of IMPs Document Number: SOP074 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager,
Use of computerised equipment, software and systems in clinical research
Standard Operating Procedures (SOP) for: Use of computerised equipment, software and systems in clinical research SOP Number: 38a Version Number: 1.0 Effective Date: 21/3/16 Review Date: 21/8/17 Author:
Document Title: Annual Progress Reports (APRs) Document Number: 056
Document Title: Annual Progress Reports (APRs) Document Number: 056 Version: 1 Ratified by: Committee Date ratified: 30/11/2017 Name of originator/author: Directorate: Department: Name of responsible individual:
Development Safety Update Report Guidance
Development Safety Update Report Guidance This document provides instructions for the preparation and submission of a Development Safety Update Report (DSUR) for a Clinical Trial of an Investigational
Standard Operating Procedure Research Governance
Research and Enterprise Standard Operating Procedure Research Governance Title: Development, Review and Amendment: Study Protocol SOP Reference Number: QUB-ADRE-002 Date prepared 28 May 2008 Version Number:
R&D Administration Manager. Research and Development. Research and Development
Document Title: Document Number: Trial Closure and End of Trial SOP021 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration
PREPARING TO RUN A TRIAL
PREPARING TO RUN A TRIAL PHASE 1 STUDIES This phase is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. STUDY DESIGN Phase I clinical trials
Computer System Validation & Backup
REFERENCE: VERSION NUMBER: 1.1 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Clinical Trials Manager, Clinical Trials Officer REVIEWED BY: R&I Senior Team APPROVED BY: Deputy Director of Research
Trial Master File. SOP No. SOP 7
Trial Master File SOP Title Trial Master File SOP No. SOP 7 Author Consultation Departments Date approved Julia Farmery Lincolnshire Clinical Research Facility, Research and Development, Trust consultants
RESEARCH SUPPORT SERVICES FRAMEWORK. Streamlining the management and governance of R&D studies in the NHS
RESEARCH SUPPORT SERVICES FRAMEWORK Streamlining the management and governance of R&D studies in the NHS Page 1 of 22 Contents 1. INTRODUCTION... 3 How to use this document... 3 Background... 4 Purpose
Standard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Creation & Maintenance of an Investigator Brochure SOP Number: 34 Version Number: 1.0 Supercedes: N/A Effective date: August
STANDARD OPERATING PROCEDURE SOP 725 CAPACITY, CAPABILITY AND RISK ASSESSMENT OF TRIALS HOSTED BY NNUH
STANDARD OPERATING PROCEDURE SOP 725 CAPACITY, CAPABILITY AND RISK ASSESSMENT OF TRIALS HOSTED BY NNUH Version 1.0 Version date 13.12.2016 Effective date 13.12.2016 Number of pages 9 pages Review date