UK Implementation of the EU Clinical Trial Directive 2001/20/EC:
|
|
- Dorothy Burke
- 8 years ago
- Views:
Transcription
1 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 2005 Version 09 Sept 05 1 UK Statutory Instrument 1031/2004, transposed the European Union Directive 2001/20/EC into UK law and was effective from 1 st May Version 09 Sept
2 MHRA own Summary of SI 1031/2004 Pharmacology studies in healthy human volunteers (Phase 1 studies) require authorisation from the MHRA where previously they only needed a favourable opinion of an ethics committee; Investigational medicinal products (IMPs) must be manufactured to good manufacturing practice (GMP) standards and the manufacturer must have a manufacturing licence; Each trial must have an identified sponsor who takes responsibility for its initiation, management and conduct. To establish our ethics committee system on a statutory basis (Regulations 5 to 10, and Schedule 2); Version 09 Sept 05 3 MHRA own Summary of SI 1031/2004 (cont) To require all clinical trials to be conducted in accordance with the principles of good clinical practice (GCP) (Regulations 28 to 31, and Schedules 1 and 5); To provide additional protection for minors and physically or mentally incapacitated adults who are candidates for clinical trials (Regulations 14 to16 and Parts 3 & 5 of Schedule 1 for incapacitated adults and Regulation 15 and Part 4 of Schedule 1 for minors ); Version 09 Sept
3 MHRA own Summary of SI 1031/2004 (cont) To require sponsors to provide trial medicines free of charge to patients if they are not covered by a prescription charge (Regulation 28); To provide for inspection by the MHRA for GCP and GMP to help ensure those standards are maintained (Regulations 47 to 52, Parts 2 & 3 of Schedule7,and Schedule 9; and To provide for enforcement of these new provisions (Regulations 47 to 52 and Schedule 9). Version 09 Sept 05 5 So what are the differences between the EU Clinical Trial Directive (2001/20/EC) and the UK Statutory Instrument (1031/2004)? Version 09 Sept
4 Good clinical practice and protection of clinical trial subjects Section 28. (1) No person shall (a) conduct a clinical trial; or (b) perform the functions of the sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor), otherwise than in accordance with the conditions and principles of good clinical practice. Version 09 Sept 05 7 New legal definition of adult in the UK. Section 2. adult means a person who has attained the age of 16 years Version 09 Sept
5 Nurses & Pharmacists can become Investigators and Chief Investigators. investigator means, in relation to a clinical trial, the authorised health professional responsible for the conduct of that trial at a trial site, and if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is the leader responsible for that team chief investigator means (a) in relation to a clinical trial conducted at a single trial site, the investigator for that site, or (b) in relation to a clinical trial conducted at more than one trial site, the authorised health care professional, whether or not he is an investigator at any particular site, who takes primary responsibility for the conduct of the trial; authorised health professional means (a) a doctor, (b) a dentist, (c) a nurse, or (d) a pharmacist; Version 09 Sept 05 9 Definition of Electronic Signature electronic signature means data in electronic form which are attached to or logically associated with other electronic data and which serve as a method of authentication; Version 09 Sept
6 Sponsor. Definition of sponsor changed from ICH and EU CTDir (wording changed with regard to individual, company, institution or organisation ) sponsor means, in relation to a clinical trial, the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial. 3(11) A person who is a sponsor of a clinical trial in accordance with this regulation must (a) be established in the European Community, or (b) have a legal representative who is so established. Version 09 Sept Urgent safety measures Reporting 3 days from date of urgent safety measures. In contrast fatal & life threatening SUSARs only require notification 7 day after sponsor is first aware. There could be several days before a sponsor is aware of action taken independently by the investigator. 30. (1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety. (2) If measures are taken pursuant to paragraph (1), the sponsor shall immediately, and in any event no later than 3 days from the date the measures are taken, give written notice to the licensing authority and the relevant ethics committee of the measures taken and the circumstances giving rise to those measures. Version 09 Sept
7 NEW Principles of GCP. (Changes / differences from ICH in Red) SCHEDULE 1 PART 2 CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline(a) 1. Clinical trials shall be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with good clinical practice and the requirements of these Regulations. 2. Before the trial is initiated, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A trial should be initiated and continued only if the anticipated benefits justify the risks. 3. The rights, safety, and well-being of the trial subjects are the most important considerations and shall prevail over interests of science and society. Version 09 Sept The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the NEW Principles of GCP. (Changes / differences from ICH in Red) cont. 5. Clinical trials shall be scientifically sound, and described in a clear, detailed protocol. 6. A trial shall be conducted in compliance with the protocol that has a favourable opinion from an ethics committee. 7. The medical care given to, and medical decisions made on behalf of, subjects shall always be the responsibility of an appropriately qualified doctor or, when appropriate, of a qualified dentist. 8. Each individual involved in conducting a trial shall be qualified by education, training, and experience to perform his or her respective task(s). 9. Subject to the other provisions of this Schedule relating to consent, freely given informed consent shall be obtained from every subject prior to clinical trial participation. Version 09 Sept All clinical trial information shall be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and 7
8 NEW Principles of GCP. (Changes / differences from ICH in Red) cont. 11. The confidentiality of records that could identify subjects shall be protected, respecting the privacy and confidentiality rules in accordance with the requirements of the Data Protection Act 1998 and the law relating to confidentiality. 12. Investigational medicinal products used in the trial shall be (a) manufactured or imported, and handled and stored, in accordance with the principles and guidelines of good manufacturing practice, and (b) used in accordance with the approved protocol. 13. Systems with procedures that assure the quality of every aspect of the trial shall be implemented. Version 09 Sept NEW Principles of GCP. (Changes / differences from ICH in Red) cont. Conditions based on Article 3 of the Directive 14. A trial shall be initiated only if an ethics committee and the licensing authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored. 15. The rights of each subject to physical and mental integrity, to privacy and to the protection of the data concerning him in accordance with the Data Protection Act 1998 are safeguarded. 16. Provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor which may arise in relation to the clinical trial. Version 09 Sept
9 Ethics Committee (EC) ONE Application for ethics committee opinion 14. (1) An application for an ethics committee opinion in relation to a clinical trial shall be made by the chief investigator for that trial. (2) A chief investigator for a trial shall make an application for an ethics committee opinion in relation to that trial to one ethics committee only, regardless of the number of trial sites at which the trial is to be conducted. New UKECA United Kingdom Ethics Committees Authority formed. Version 09 Sept Workings of Ethics Committee (differences from the Directive in red) Includes contract between sponsor & site. (h) if the subjects are to include persons incapable of giving informed consent, whether the research is justified having regard to the conditions and principles specified in Part 5 of Schedule 1; (l) the terms of any agreement between the sponsor and the owner or occupier of the trial site which are relevant to the arrangements referred to in sub-paragraph (k); and Version 09 Sept
10 Workings of Ethics Committee (Cont.) The UK may have taken a provision from the EU guidance note on submissions to EC [ENTR/F2/BL D (2003) April 2003 & ENTR/CT2 revision 1 April 2004] and put it into the UK Law: Financial arrangements. This includes information on financial transactions, and compensation to subjects and investigator/site. It might be the responsibility of either the Ethics Committee or the competent authority to review the arrangements for rewarding or compensating investigator(s) / sites and trial subjects as well as the relevant aspects of any agreement between the sponsor and the site according to national provisions. Version 09 Sept Most importantly UK SI 1031 has given powers for GCP Inspections. Version 09 Sept
11 MHRA Inspection Findings Most frequent non-compliances from the Statutory Programme Version 09 Sept UK MHRA GCP Inspection Findings Contracts, agreements and insurance Contracts not in place Responsibilities not clearly defined Unclear ownership of documents and data Lack of consistency between protocol and contract Insurance includes exemptions which may not cover certain patient populations Version 09 Sept
12 UK MHRA GCP Inspection Findings Quality Systems Lack of essential SOPs SOPs not updated SOPs do not reflect current practice or current legislation Insufficient time between SOP issues and becoming effective, which leads to training issues Lack of QA activity, no involvement in vendor selection Meetings and decisions not documented Version 09 Sept UK MHRA GCP Inspection Findings Investigational Medicinal Product Missing documentation: shipping records, accountability, dosing records Emergency codes not supplied prior to study start Ethical approval Lack of approval for study advertising Version 09 Sept
13 UK MHRA GCP Inspection Findings Informed Consent Missing elements Inconsistencies with protocol, not updated with protocol amendments Poor version control Incorrect form used Unclear process Version 09 Sept UK MHRA GCP Inspection Findings Subject safety and confidentiality Lack of involvement of PI Unclear procedures (and testing of procedures) for out of hours emergency contacts Subjects not provided with emergency contact details Subject details sent into Sponsor company Ineligible subjects entered into studies Version 09 Sept
14 UK MHRA GCP Inspection Findings Miscellaneous Findings Lack of documentation of validation of computer systems Uncontrolled database unlock/re-lock Lack of GCP training Lack of documented calibration of equipment Unidentified or unexpected laboratory samples analysed for a range of tests - this may be outside the protocol and therefore without consent. Version 09 Sept Any Questions? Version 09 Sept
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 informationDESCRIPTION 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
More informationStandard 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 informationStandard 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 informationManaging 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 informationWhat 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 informationTRIAL 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 informationMRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council
MRC Clinical Trials Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 Medical Research Council MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 MRC GUIDELINES FOR
More informationHaving regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
L 121/34 DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to
More informationSTANDARD 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 informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2001L0020 EN 07.08.2009 002.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT
More informationSheffield Kidney Institute. Planning a Clinical Trial
Planning a Clinical Trial Clinical Trials Testing a new drug Ethical Issues Liability and Indemnity Trial Design Trial Protocol Statistical analysis Clinical Trials Phase I: Phase II: Phase III: Phase
More informationThe 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
More informationThe EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Denmark Question 1: What laws or regulations apply to an application for conducting a clinical
More informationGuidance to Research Ethics Committees on Initial Facility Assessment
Guidance to Research Ethics Committees on Initial Facility Assessment Introduction One of the roles of a Research Ethics Committee is to provide an opinion on a proposed study, based on the suitability
More informationGood Clinical Practice 101: An Introduction
Good Clinical Practice 101: An Introduction Presented by: Lester Jao Lacorte, MD Medical Officer Commissioner s Fellow Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological
More informationArchiving 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 informationMedicines for Human Use (Clinical Trials Regulations) 2004. Informed consent in clinical trials
Medicines for Human Use (Clinical Trials Regulations) 2004 Informed consent in clinical trials Introduction 1. This information note summarises the statutory requirements for informed consent of participants
More informationIntroduction 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 informationgsop-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 informationClinical 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
More informationEssentials of RESEARCH GOVERNANCE
Promoting Good Practice in Research Essentials of RESEARCH GOVERNANCE Information for Researchers, Students and Support Staff involved in Health & Social Care Research 2005 Reproduced with the permission
More informationA responsible approach to clinical trials. Bioethics in action
A responsible approach to clinical trials Bioethics in action What is bioethics? At Novo Nordisk bioethics is the expression used for all ethical issues related to the use of life science technologies
More informationArchiving 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 informationThe 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);
More informationOECD Recommendation on the Governance of Clinical Trials
OECD Recommendation on the Governance of Clinical Trials Marketing authorisation status of the medicinal products Non-authorised medicine Authorised medicine, treatment regimen outside
More informationClinical 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
More informationCNE Disclosures. To change this title, go to Notes Master
CNE Disclosures Successful Completion: Participants must complete an evaluation form to receive a certificate of completion Contact Hours: 1 contact hour is available to those who meet the successful completion
More informationClinical 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
More informationHistory and Principles of Good Clinical Practice
History and Principles of Good Clinical Practice Cristina E. Torres, Ph.D. Social Science Professor, UPM-NIH FERCAP Coordinator ICH: International Conference on Harmonization GCP: Good Clinical Practices
More informationResponse of the German Medical Association
Response of the German Medical Association to the European Commission proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and
More informationRESEARCH 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 informationInsurance and compensation in the event of injury in Phase I clinical trials
Insurance and compensation in the event of injury in Phase I clinical trials Guidance developed by the Association for the British Pharmaceutical Industry, the BioIndustry Association and the Clinical
More informationICRIN 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
More informationSerious Breaches. Ian Gravenor. Senior Clinical Project Manager Novo Nordisk Ltd
Serious Breaches Ian Gravenor Senior Clinical Project Manager Novo Nordisk Ltd Serious Breaches of GCP or the Trial Protocol Agenda Why report? The legislation MHRA Guidance document Timelines Actions
More informationInformation for members
Information for members I-04-63 Suggested distribution Vice-Chancellors and Principals, Pro Vice- Chancellors (Research), University Registrars and Secretaries, Directors of Human Resources, Deans/Heads
More informationThe 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
More informationThe EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2012) Sweden
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe Sweden Question 1: What laws or regulations apply to an application for conducting a clinical trial in Sweden?
More informationChemicals and Life Sciences Industry Practice. Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom
Chemicals and Life Sciences Industry Practice Insurance and compensation in the event of injury in Phase I clinical trials in the United Kingdom i Insurance and compensation in the event of injury in Phase
More informationROLES, 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 informationStudy-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 informationCLINICAL TRIALS WITH MEDICINES IN EUROPE
CLINICAL TRIALS WITH MEDICINES IN EUROPE REGULATORY FRAMEWORK FOR CLINICAL TRIALS WITH MEDICINES IN EUROPE The pharmaceutical industry is the most highly regulated sector in Europe. The Commission has
More informationStandard 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 informationHealth Canada s GCP Compliance Program. GCP Information Sessions November 2010
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010 Objective To describe the role that Health
More informationCLINICAL RESEARCH IN EUROPE AFTER THE EU DIRECTIVE ON CLINICAL TRIALS. DOMENICO CRISCUOLO, MD, FFPM CMO at CREABILIS THERAPEUTICS IFAPP PAST PRESIDENT
CLINICAL RESEARCH IN EUROPE AFTER THE EU DIRECTIVE ON CLINICAL TRIALS DOMENICO CRISCUOLO, MD, FFPM CMO at CREABILIS THERAPEUTICS IFAPP PAST PRESIDENT EU : SOME FACTS 25 MEMBERS + 3 CANDIDATES 500.000.000
More informationEMA 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,
More informationEthics 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 informationClinical 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 informationGOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE
ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investigator's
More informationBiotech Concerto #3. European Clinical Trial Environment
Biotech Concerto #3 European Clinical Trial Environment December 2008 Index EU Directive EU Approval System European Authority: EMEA The Guidance Documents Route Map Challenges EMEA Organization Chart
More informationRECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING
RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Introduction 2 2. Scope 2 3. Documents to be archived 2 4. Quality of essential documents 10 5.
More informationThe 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
More informationTHE CLINICAL TRIALS BILL (No. XIX of 2010) Explanatory Memorandum
THE CLINICAL TRIALS BILL (No. XIX of 2010) Explanatory Memorandum 1. The object of this Bill is to provide the legal framework for the conduct of clinical trials for the purpose of discovering or verifying
More informationClinical Trials - Insurance and Indemnity
Policy Directive Clinical Trials - Insurance and Indemnity Document Number PD2011_006 Publication date 25-Jan-2011 Functional Sub group Corporate Administration - Governance Clinical/ Patient Services
More informationJoint 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 informationGuidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials
More informationBackground Definition Why do we need it? The process of obtaining informed consent A brief overview of special situations Conclusion
Joanna Forbes Senior Clinical Research Nurse Ethical and legal considerations Background Definition Why do we need it? The process of obtaining informed consent A brief overview of special situations Conclusion
More informationGLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com
GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process
More informationCONTROLLED 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 informationSummary 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 informationA 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 informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: SOP number: SOP category: Document Control GE-003 General SOP history Version number: 01 Version date: 1 March 2013 Effective
More informationRoles & Responsibilities of the Sponsor
Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from
More informationThe 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 informationLegal and governance framework
Annex A Legal and governance framework This annex is a brief guide to the legal and governance framework relevant to research in the UK. It is not intended to be a comprehensive statement of the law or
More informationOversight of Clinical Trials in Europe - Member State perspective. Gunnar Danielsson Senior Expert Pharmaceutical Inspector
Oversight of Clinical Trials in Europe - Member State perspective Gunnar Danielsson Senior Expert Pharmaceutical Inspector Oversight of Clinical Trials Oversight of clinical trials occur on many different
More informationand 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
More informationDate : Date of start of procedure: Authorisation/ positive opinion :
Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use,
More informationEUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/F2/BL D(2003) CT 1 Revision 2
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, ENTR/F2/BL D(2003)
More informationFederal agency for medicines and health products
Federal agency for medicines and health products A critical review of the proposed EU Clinical Trial regulation Walter Janssens Kristof Bonnarens April 2013 CT regulation - general Commission adopted the
More informationSOP 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,
More informationThe 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
More informationGuide to Clinical Trial Applications
Guide to Clinical Trial Applications AUT-G0001-9 DATE 29 JUNE 2015 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS ABBREVIATIONS
More informationThe 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
More informationManaging & Validating Research Data
Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical
More informationReflection 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
More informationGuide to Regulatory Requirements for the Procurement of Human Tissues and Cells intended for Human Application
Guide to Regulatory Requirements for the Procurement of Human Tissues and Cells intended for Human AUT-G0102-1 3 JANUARY 2013 This guide does not purport to be an interpretation of law and/or regulations
More informationRegulation 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)
More informationWORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by
More informationThe 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
More informationResources 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
More informationGOOD CLINICAL PRACTICE*)
GOOD CLINICAL PRACTICE*) Guideline Title Good Clinical Practice*) Legislative basis Directive 75/318/EEC as amended Date of first adoption July 1990 This version July 1996 Date of entry into January 1997
More informationAdoption 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
More informationSTANDARD 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 informationResearch Governance Framework for Health and Social Care
Research Governance Framework for Health and Social Care Second edition, 2005 Research Governance Framework for Health and Social Care Foreword The Research Governance Framework outlines principles of
More informationICH Topic E 6 (R1) Guideline for Good Clinical Practice. Step 5 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95)
European Medicines Agency July 2002 CPMP/ICH/135/95 ICH Topic E 6 (R1) Guideline for Good Clinical Practice Step 5 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) TRANSMISSION TO CPMP July
More informationResearch 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 informationAppendix 1 Waiver of the requirement for informed consent for a clinical trial in a medical emergency Page 1 of 2
Appendix 1 Waiver of the requirement for informed consent for a clinical trial in a medical emergency Page 1 of 2 The Helsinki Committee may approve a clinical trial without the requirement to obtain informed
More informationClinical Trial Compensation Guidelines
Clinical Trial Compensation Guidelines Preface These guidelines contain two distinct sections: Phase I Clinical Trials Compensation Guidelines Phases II, III and IV Clinical Trials Compensation Guidelines
More informationICH Topic E 6 Guideline for Good Clinical Practice NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) *
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit ICH Topic E 6 Guideline for Good Clinical Practice Step 5, Consolidated Guideline 1.5.96 NOTE FOR GUIDANCE ON
More informationGood 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
More informationThe 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
More informationReflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
1 2 3 5 August 2011 EMA/INS/GCP/600788/2011 Compliance and Inspection 4 5 6 7 Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
More informationSTANDARD 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 informationThe Changing Regulatory Requirements for Applied Human Pharmacology. Thomas Sudhop Federal Institute for Drugs and Medical Devices (BfArM)
The Changing Regulatory Requirements for Applied Human Pharmacology Thomas Sudhop Federal Institute for Drugs and Medical Devices (BfArM) What was first The Regulatory Past Rules for Marketing Authorisation
More informationThe EU portal and database
The EU portal and database ECPC General Assembly - 20 June 2015 Presented by Laura Pioppo Clinical and Non-clinical Compliance Service An agency of the European Union Table of contents Legal basis CT programme
More information2002 No. 618 CONSUMER PROTECTION. The Medical Devices Regulations 2002
STATUTORY INSTRUMENTS 2002 No. 618 CONSUMER PROTECTION The Medical Devices Regulations 2002 Made - - - - - 20th May 2002 Laid before Parliament 21st May 2002 Coming into force - - 13th June 2002 ARRANGEMENT
More informationGCP 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
More informationEUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/CT 1. Revision 1
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, ENTR/CT 1 Revision
More informationGood Clinical Laboratory Practice (GCLP) An international quality system for laboratories which undertake the analysis of samples from clinical trials
Good Clinical Laboratory Practice (GCLP) An international quality system for laboratories which undertake the analysis of samples from clinical trials Vanessa Grant and Tim Stiles VERSION 2 Published by
More information