Serious Breaches. Ian Gravenor. Senior Clinical Project Manager Novo Nordisk Ltd
|
|
|
- Evangeline Clarke
- 8 years ago
- Views:
Transcription
1 Serious Breaches Ian Gravenor Senior Clinical Project Manager Novo Nordisk Ltd
2 Serious Breaches of GCP or the Trial Protocol Agenda Why report? The legislation MHRA Guidance document Timelines Actions Identifying breaches and examples What did Novo Nordisk do? Slide no 2 Serious Breaches ICR Northwest Forum 13th May 2010
3 EU GCP Directive 2005/28/EC Builds on EU Clinical Trials Directive 2001/20/EC Put into UK law as an amendment by means of a Statutory Instrument (2006/1928) Article 29A of this SI contains a requirement for the notification of serious breaches of GCP or the trial protocol Slide no 3 Serious Breaches ICR Northwest Forum 13th May 2010
4 Serious Breaches Article 29A 29A (1) The Sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of (a) the conditions and principles of GCP in connection with that trial; or (b) the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25, within 7 days of becoming aware of that breach Slide no 4 Serious Breaches ICR Northwest Forum 13th May 2010
5 Serious Breaches Article 29A Article 29A (2) For the purpose of this regulation, a serious breach is a breach which is likely to affect to a significant degree (a) the safety or physical or mental integrity of the subjects of the trial; or (b) the scientific value of the trial Slide no 5 Serious Breaches ICR Northwest Forum 13th May 2010
6 Serious Breaches why? Enhance the safety of trial subjects by seeking to ensure that the licensing authority is promptly informed of such serious breaches, in order to take appropriate action in response to the breach and/or, To take the information regarding serious breaches into account when assessing future applications for clinical trial authorisation, and applications for marketing authorisation, which include data from trials affected by serious breaches Slide no 6 Serious Breaches ICR Northwest Forum 13th May 2010
7 Guidance on Serious Breaches MHRA Guidance document that: outlines the practical arrangements for notification provides advice on what should and should not be classified as a serious breach and what must be reported outline possible actions that may be taken by the MHRA in response to notifications of serious breaches Serious Breaches Guidance Version 2 (Final, 15/10/09) Article from CRFocus that summarises the MHRA guidance document (Vol 18, No. 4, April ) Slide no 7 Serious Breaches ICR Northwest Forum 13th May 2010
8 Timelines Notification has to be made within 7 days of the Sponsor becoming aware of the breach If this function has been delegated by the Sponsor the 7 day timeframe applies to whoever has been delegate the task The Sponsor should obtain written agreement from others, i.e. CRO, investigators, etc that they will promptly report serious breaches Slide no 8 Serious Breaches ICR Northwest Forum 13th May 2010
9 Timelines The Sponsor should define the requirements in their SOPs As with SUSAR reporting, the clock starts when the Sponsor becomes aware of the serious breach Sponsors might need to investigate the deviation to be able to assess whether or not a breach is serious Once identified as a serious breach this triggers the 7 days in which to notify the MHRA However, the Sponsor should not wait for ALL details of the breach prior to notification Slide no 9 Serious Breaches ICR Northwest Forum 13th May 2010
10 Timelines If an inspector considers the notification to have been inappropriately delayed, this might also be classed as non-compliance The MHRA GCP group are willing to discuss whether a particular breach needs to be notified. Slide no 10 Serious Breaches ICR Northwest Forum 13th May 2010
11 Actions The matter does not stop once notification is made The Sponsor must take and document appropriate corrective and preventative actions in response to the serious breach The actions and documentation will be reviewed during an MHRA inspection Slide no 11 Serious Breaches ICR Northwest Forum 13th May 2010
12 Identifying Serious Breaches Not all deviations from the protocol are considered serious Deviations from the protocol and from GCP do occur; most are regarded as technical deviations which do not result in harm to the trial subjects or affect the scientific value of the study These are usually documented and commented upon in the final study report Slide no 12 Serious Breaches ICR Northwest Forum 13th May 2010
13 Identifying Serious Breaches For the purposes of this regulation, a serious breach is a breach which is likely to effect to a significant degree (a) the safety or physical or mental integrity of the subjects of the trial; or (b) the scientific value of the trial Slide no 13 Serious Breaches ICR Northwest Forum 13th May 2010
14 Identifying Serious Breaches The difficulty is judging whether or not a given breach is serious This judgement can be complex, depending on a variety of factors, such as type of trial, complexity of the study etc. Inaccurate judgement can lead to problems in audit/inspection or in later regulatory submissions It is the responsibility of the Sponsor to assess the impact of the breach on the scientific value of the trial Slide no 14 Serious Breaches ICR Northwest Forum 13th May 2010
15 Examples A breach of GCP or protocol deviation leading to the death, hospitalisation or disability of a trial subject in the UK. Not all SAE/SUSARs would routinely be regarded as serious breaches, but those that are a result of GCP or protocol non-compliance might. If a SUSAR is notified as a serious breach, it will still need to be reported and submitted to the EudraVigilance database Slide no 15 Serious Breaches ICR Northwest Forum 13th May 2010
16 Examples Failure to report AEs, SAEs or SUSARs in accordance with the UK legislation, such that subjects are put at risk Proof of fraud relating to clinical trial records or data that impacts on the integrity of trial subjects or scientific value of the data Slide no 16 Serious Breaches ICR Northwest Forum 13th May 2010
17 Examples Persistent or systematic non-compliance with GCP or the protocol that has a significant impact on the integrity of trial subjects in the UK or on the scientific value of the trial. Failure to control investigational medicinal product such that subjects or the public are put at risk or the scientific value of the trial is compromised. Serious breaches in non-uk sites that impact on UK subject integrity and/or that affects the scientific value of the trial Slide no 17 Serious Breaches ICR Northwest Forum 13th May 2010
18 What Did Novo Nordisk do in response to the requirement to report serious breaches? Started local in the UK affiliate set up mailbox to report cases set up quorum to review cases quickly to decide whether to report or not wrote local UK SOP Going global expanding SOP across the company globally in progress. Slide no 18 Serious Breaches ICR Northwest Forum 13th May 2010
19 Local SOP Mailbox set up to report breaches avoids reliance of one person to pick up and act on it Quorum to review each case reported 5 members, of which minimum of 3 will make decision Quorum to consist of 2 x PM, 2 x CRA, 1 x CRM Quorum to consult other experts e.g. Safety dept, DM dept where needed If no consensus reaches seek advice from MHRA or report as a potential serious breach Slide no 19 Serious Breaches ICR Northwest Forum 13th May 2010
20 Documentation Database of cases maintain a DB of all cases reported and not Keep a file of each case so that there is an audit trail particularly important to have documentation on when it was first identified within the company and when it was reported Summary list of each case for quick review/identification Inspections Inspectors will want to see procedure and list of all cases to date NN provided the list and brief summary of each case and cases were chosen to look at in more detail Slide no 20 Serious Breaches ICR Northwest Forum 13th May 2010
21 Deciding is it or isn t it??? Cases are not straightforward Guidance is grey and vague Timelines are very short Information available at the time is limited Slide no 21 Serious Breaches ICR Northwest Forum 13th May 2010
22 Completing the Form what is the breach why you think it s a breach what action you have taken what action you are currently taking what action and follow up you will take provide updates to the MHRA as new information becomes available and document the impact of this information on the case Slide no 22 Serious Breaches ICR Northwest Forum 13th May 2010
23 Cases at NN To date 11 cases have been reviewed by NN quorum 5 were reported as serious breaches or potential serious breaches cases included temperature monitoring of trial products, informed consent, trial product handling, source data issues, trial data issues NN were inspected by the MHRA in 2008 reporting procedure was praised cases looked at were well documented and reported correctly minor comment one case that involved Ireland as well as UK it was recommended that the IMB could have notified of the breach as well as the MHRA however no formal requirement Slide no 23 Serious Breaches ICR Northwest Forum 13th May 2010
24 Experience to date.. Inspectors are very helpful and approachable about cases Always good to report potential breaches and state following up on the case Shows that you are pro-active and monitoring your procedures Interested in the procedure that you have in place Always interested in documentation! If in doubt either discuss with MHRA or report as potential breach Slide no 24 Serious Breaches ICR Northwest Forum 13th May 2010
25 Thank You!
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
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
EU Clinical Trials Regulation Regulation EU 536/2014
EU Clinical Trials Regulation Regulation EU 536/2014 María Jesús Zafra Director, QA & Compliance Table of contents 1 2 3 4 Introduction Timelines and main changes Highlights 5 Impact on company processes
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,
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
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
The EU Clinical Trial Regulation A regulator s perspective
5 The EU Clinical Trial A regulator s perspective Author Martyn Ward, Group Manager, Licensing, Medicines and Healthcare products Regulatory Agency (MHRA), UK. Keywords Clinical Trial Directive (the Directive);
ICRIN Seminar on EU Regulation of Clinical Trials
ICRIN Seminar on EU Regulation of Clinical Trials 12 th March 2013, Dublin J. Michael Morris Director Scientific Affairs IRISH MEDICINES BOARD 28/03/2013 Slide 1 Overview Clinical Trial (CT) legislation
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,
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:
Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals
Detailed guidance AEs reporting in clinical trials ( CT-3 ) Stefano Bonato, M.D. Pharmacovigilance Country Head Bayer HealthCare Pharmaceuticals Pharmacovigilance costs 0.12%-0.22% of hospital admissions
Site visit inspection report on compliance with HTA minimum standards. London School of Hygiene & Tropical Medicine. HTA licensing number 12066
Site visit inspection report on compliance with HTA minimum standards London School of Hygiene & Tropical Medicine HTA licensing number 12066 Licensed under the Human Tissue Act 2004 for the storage of
The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations
The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations Maria Luisa Paoloni OPBG Clinical & Research Services Monitoring and Responsible of monitoring:
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
GCP Inspection of Ti Trial Master Files
Safeguarding public health GCP Inspection of Ti Trial Master Files DIA, 12th Conference on European Electronic Document Management/ EDM Crown copyright 2011 The materials featured within these MHRA presentation
Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity
Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good
Essential Documents for Clinical Trial Research. Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office
Essential Documents for Clinical Trial Research Erin Cherban, MSc., CCRP Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office Document Examples See the following
The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Russia
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Russia Question 1: What laws or regulations apply to an application for conducting a clinical
DESCRIPTION OF THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004
DESCRIPTION OF THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004 Page 1 of 17 TABLE OF CONTENTS INTRODUCTION 4 EXECUTIVE SUMMARY 4 PUBLIC HEALTH BENEFITS 5 Good clinical practice 5 Good manufacturing
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
Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP.
Role of IRB/IEC in GCP Benjamin Kuo, MD, Dr.PH, CIP. Institutional Review Board (IRB) An independent body constituted of medical, scientific and non scientific members Responsible for ensuring protection
and Regulatory Aspects
Good Clinical Practice and Regulatory Aspects Nora Espiritu MD, MPh, PhD (c) Former Executive Director of Research and Technology Transfer. Peruvian National Institute t of Health. Member of the Ethics
New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)
Safeguarding public health New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Tony Orme, Senior GDP Inspector Inspection, Enforcement and Standards Division
Quality Monitoring Checklist
Quality Monitoring Checklist Instructions: For each task below, the Quality Monitor indicates in the appropriate column if the Monitor accomplished the task by using the following codes Yes No N/A = Monitor
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
Industry Experience in Clinical Trials Management. Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels
Industry Experience in Clinical Trials Management Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels Stakeholders in clinical research Critical activities to ensure patient
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
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,
An Overview of Clinical Archiving. Russell Joyce Records & Information Manager
An Overview of Clinical Archiving Russell Joyce Records & Information Manager Objectives To understand the Historical context of archiving Importance of archiving Regulatory & legal frameworks Archiving
Clinical trials: from European perspective to National implementation. CTFG / FAMHP / pharma.be. Brussels, 19 November 2010
Clinical trials: from European perspective to National implementation CTFG / FAMHP / pharma.be Brussels, 19 November 2010 Safety in clinical trials: From detection to decision How safety events are captured
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:
The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly
A Full-Service International CRO The New EU Clinical Trials Regulation: The Good, the Bad, the Ugly Dr. Martine Dehlinger-Kremer Vice President, Global Medical and Regulatory Affairs The original intent
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
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
Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples
28 February 2012 EMA/INS/GCP/532137/2010 GCP Inspectors Working Group Reflection paper for laboratories that perform the analysis or evaluation of clinical trial Draft agreed by GCP Inspectors Working
The New EU Clinical Trial Regulation Potential Impacts on Sites
The New EU Clinical Trial Regulation Potential Impacts on Sites Angela Papa Associate Director, Clinical Management PPD Pierre-Frédéric Omnes Director, Site Start-Up and Regulatory INC Research Faculty
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
EFPIA Principles for the Development of the EU Clinical Trials Portal and Database
Position Paper EFPIA Principles for the Development of the EU Clinical Trials Portal and Database Executive summary EFPIA sees the implementation of the Clinical Trials Regulation 1 as an opportunity to
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
European Medicines Agency Veterinary Medicines and Inspections London, 18 May 2006 Doc. Ref. EMEA/CVMP/32995/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON THE PROCEDURE FOR
Clinical research: where are we with the new (Paediatric) RC trial Regulation
where are we with the new (Paediatric) RC trial Regulation, MD, PhD Ethical Committee DEEP Former member of the PDCO EMA With the aid of Fabio D'Atri European commission and Anabela Marcal of EMA The new
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
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
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
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
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 17 July 2006 Doc. Ref. EMEA/419127/05 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PROCEDURE
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.
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
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
The Monitoring Visit. Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis
The Monitoring Visit Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis Disclosure The information herein is not intended to
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
The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Norway
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Norway Question 1: What laws or regulations apply to an application for conducting a clinical
EMA Update Clinical Trials
EMA Update Clinical Trials Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency 16 October 2012 An agency of the European Union Disclaimer The views presented in this presentation/these
APEC Preliminary Workshop: Review of Drug
APEC Preliminary Workshop: Review of Drug Development in Clinical Trials Session 1.4 -Clinical Trial Environment United States (FDA) and European Union (EMEA) Susan D Amico Vice President and Global Head
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
Clinical trials regulation
Clinical trials regulation The Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001/20/EC an update
The Clinical Trials Directive in the EU: Present and Future Elisabethann Wright, Partner Maurits Lugard, Partner. May 2010
The Clinical Trials Directive in the EU: Present and Future Elisabethann Wright, Partner Maurits Lugard, Partner May 2010 Background (1) The Clinical Trials Directive 2001/20/EC The intention of this Directive
Clinical trials in developing countries submitted to EMEA for regulatory purposes
Clinical trials in developing countries submitted to EMEA for regulatory purposes Rome, UNICRI/AIFA December 2008 Hans-Georg Eichler Agenda Challenges EU regulatory requirements for clinical trials Facts
Standard Operating Procedure for the Recording, Management and Reporting of Adverse Events by Investigators
ASR\INV_S05_SOP for AE_SAE_Reporting by Inv_V06.doc Page 1 of 19 Standard Operating Procedure for the Recording, Management and Reporting of Adverse Events by Investigators SOP Number: Effective Date:
Adventist HealthCare, Inc.
IRB POLICY ON HUMAN RESEARCH PROTECTION (HRP) AND GOOD CLINICAL PRACTICE (GCP) TRAINING Collaborative Institutional Training Initiative (CITI) Requirements at Adventist Healthcare, Inc. I. Required Human
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) Joanne Thompson Clinical Trials Monitor and Trainer, UHL Dec 2011 1 1 What is GCP? An international ethical and scientific quality standard for designing, conducting, recording
SOP Number: SOP-QA-20 Version No: 1. Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen)
Standard Operating Procedure: SOP Number: SOP-QA-20 Version No: 1 Author: Date: 1-9-15 (Patricia Burns, Research Governance Manager, University of Aberdeen) Approved by: Date: 1-9-15 (Professor Julie Brittenden,
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
The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor
The Concept of Quality in Clinical Research Dorota Śwituła Senior Clinical Quality Assurance Advisor 1 Agenda What is quality? How we define quality in clinical research? The standard components of a Quality
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
Quality Management in Clinical Trials
CLINICAL CASE STUDY SERIES Quality Management in Clinical Trials Clinical trials are conducted to collect the data necessary to provide information for academia, industry, and regulators to make decisions
Audit and Risk Committee Charter. 1. Membership of the Committee. 2. Administrative matters
Audit and Risk Committee Charter The Audit and Risk Committee (the Committee ) is a Committee of the Board established with the specific powers delegated to it under Clause 8.15 of the Company s Constitution
Document Title: Supply of Clinical Trials Investigational Material: Dispensing, Returns and Accountability
Document Title: Supply of Clinical Trials Investigational Material: Document Number: SOP072 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G
Regulation of clinical trials with medicinal products: Where are we now?
Regulation of clinical trials with medicinal products: Where are we now? Mariantonia Serrano Castro Department of Medicines for Human Use Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
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
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,
GCP INSPECTORS WORKING GROUP <DRAFT> REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS
European Medicines Agency London, 17 October 2007 Doc. Ref. EMEA/505620/2007 GCP INSPECTORS WORKING GROUP REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS
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?
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
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
Guideline on good pharmacovigilance practices (GVP)
1 2 20 February 2012 EMA/541760/2011 3 4 Guideline on good pharmacovigilance practices (GVP) Module I Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration
The European Clinical Trials Framework Update on the Draft Clinical Trials Regulation
The European Clinical Trials Framework Update on the Draft Clinical Trials Regulation Dr. Ilona Reischl BASG/AGES Austrian Agency for Health and Food Safety GmbH Content - References "Proposal for a Regulation
New Investigator Collaborations and Interactions: Regulatory
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials
Your duties as a registrant. How to complete your continuing professional development profile
Your duties as a registrant How to complete your continuing professional development profile Contents About this document 1 Section 1: Submitting your CPD profile 2 Auditing the CPD of health and care
Working Party on Control of Medicines and Inspections. Final Version of Annex 16 to the EU Guide to Good Manufacturing Practice
Version 8 (final) EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 S\common\legal-legislation\75-319nd81-851\91-356\eudralexvol4\Annex
Effective Date: October 2015
University of Maryland Greenebaum Cancer Center UMGCC Standard Operating Procedure Title: Data & Safety Monitoring Plan Effective Date: October 2015 Procedure No: DSM001 University of Maryland Greenebaum
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
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...
Resources Based, Manufacturing and Consumer Goods Industries Chemicals Industry
EUROPEAN COMMISSION Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs Resources Based, Manufacturing and Consumer Goods Industries Chemicals Industry Version March 2015 QUESTIONS
How To Inspect A Blood Bank
Site visit inspection report on compliance with HTA minimum standards Belfast Cord Blood Bank HTA licensing number 11077 Licensed for the procurement, processing, testing, storage, distribution and import/export
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
20 & 21 October 2005 Clinical trials Risk issues within a wider Europe. Adrien Collovray Marsh Life Science Conference 2005 Berlin, Germany
20 & 21 October 2005 Clinical trials Risk issues within a wider Europe Adrien Collovray Life Science Conference 2005 Berlin, Germany Clinical trials EC Directive on clinical trials Insurance Requirements
Adoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012
10 December 2013 EMA/INS/GCP/600788/2011 Compliance and Inspection Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular
Internal controls Guidance for trustees
Regulatory code of practice no. 9 Internal controls Guidance for trustees Contents Paragraph Page 1 Introduction 3 5 The status of codes of practice 3 6 Other regulatory requirements 3 7 Terminology 4
12.0 Investigator Responsibilities
v. 5.13.13 12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement,
Guidance for CTUs on Assessing the Suitability of Laboratories Processing Research Samples
Guidance for CTUs on Assessing the Suitability of Laboratories Processing Research Samples UKCRC Registered CTUs Network Guidance for CTUs on Assessing the Suitability of Laboratories Processing Research
Guidance notes. for Patient Safety and Pharmacovigilance in Patient Support Programmes
Guidance notes for Patient Safety and Pharmacovigilance in Patient Support Programmes 9 May 2011 Approval Status Authors The ABPI Pharmacovigilance Expert Network Change History N/A Approval Date 9 May
PROCEDURE FOR PREPARING GCP INSPECTIONS REQUESTED BY THE EMEA. GCP Inspectors Working Group
European Medicines Agency Inspections London, 20 September 2007 EMEA/INS/GCP/197228/2005 Procedure no.: INS/GCP/2 PROCEDURE FOR PREPARING GCP INSPECTIONS REQUESTED BY THE EMEA GCP Inspectors Working Group
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
THE ACTIVITIES AND FUTURE DEVELOPMENT OF GCP INSPECTIONS IN TANZANIA
THE ACTIVITIES AND FUTURE DEVELOPMENT OF GCP INSPECTIONS IN TANZANIA Godwin D. Ndossi, PhD Chairman Tanzania National Health Research Forum Formerly, Managing Director Tanzania Food and Nutrition Centre
The Regulatory Reform (Fire Safety) Order 2005: Enforcement Policy
COMMUNITY SAFETY The Regulatory Reform (Fire Safety) Order 2005: Enforcement Policy Relevant legislation The Fire and Rescue Services Act 2004 The Regulatory Reform (Fire Safety) Order 2005 Legislative
ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014
ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014 1. Introduction The St. Michael s Hospital (SMH) REB
The Clinical Trials Regulation EU No 536/2014: and Phase I trials
The Clinical Trials Regulation EU No 536/2014: and Phase I trials EUFEMED, Brussels, 20 May 2015 Presented by Fergus Sweeney Head, Inspections and Human Medicines Pharmacovigilance An agency of the European
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
We are the regulator: Our job is to check whether hospitals, care homes and care services are meeting essential standards.
Inspection Report We are the regulator: Our job is to check whether hospitals, care homes and care services are meeting essential standards. Harrow Health Limited 37 Love Lane, Pinner, Harrow, HA5 3EE
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