Managing Risk in Clinical Research. Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey
|
|
- Edwin Farmer
- 8 years ago
- Views:
Transcription
1 Managing Risk in Clinical Research Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey
2 Aim of the session To explore the risks associated with clinical research and understand how these are mitigated Provide an opportunity for discussion and debate concerning how risk for clinical research is identified and accessed Key Objective Link the research assessment to the NHS Litigation Authority (NHSLA)
3 World Health Organization Definition for Clinical Research A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. (
4 What do you think are the risks associated with conducting clinical research? And how could these risks be addressed?
5 NHS Litigation Authority The NHS Litigation Authority (NHSLA) is a Special Health Authority that was set up in The NHSLA handles negligence claims made against NHS organisations and works to improve risk management practices in the NHS.
6 Why have the standards been developed? improve the safety of patients, staff and others; provide a framework within which to focus risk management activities in order to support the delivery of quality improvements in patient care, organisational governance, and the safety of patients assist in the identification of risk contribute to embedding risk management into the organisation s culture (ref: NHSLA Risk Management Standards Version 2 July 2012)
7 NHS Litigation Authority OVERVIEW OF RISK AREAS
8
9 Why we need standards for research Safeguard and protect research participants Risk reduction Quality data Excellent research Good science Trustworthy findings
10 Central philosophy: Protection of the rights, safety and well-being of our patients and participants
11 Standard 1 Governance Risk Management Strategy Policy on Procedural Documents Risk Management Committee Risk Register Dealing with external recommendations
12 Governance Three tiers of approval for research: Medicines and Health Care products Regulatory Agency (MHRA) Independent ethics review Trust review (R&D approval / NHS Permission)
13 MHRA Established in 2003, bringing together the medicines Control Agency and the Medical Devices Agency The UK competent authority responsible for the regulation of medicines, including the regulation of clinical trials, and devices and equipment used in healthcare
14 National Research Ethics Service (NRES) Studies submitted to the UK Integrated Research Application System (IRAS) An independent body of medical and lay members The rights, safety and well-being of the trial subject are the most important consideration and should prevail over interests of science and safety Health Research Authority newly established Dec Coordination and streamlining ethics processes.
15 R&D Departments Research Governance Framework Issued by the Department of Health in April 2001 to provide a framework from which health and social care organisations can host and support safe, high quality research. Implemented by 2004, R&D Departments established Identifies responsibilities to be adopted by NHS organisations hosting the research Must be adhered to for all trials conducted within the NHS in England
16 Standard 2 Learning from experience Clinical Audit Incident Reporting Concerns and Complaints Investigations Being open
17 Nuremberg Trials The Doctors Trial considered the fate of twenty-three German physicians who either participated in the Nazi program to euthanize persons deemed "unworthy of life" (the mentally ill, mentally retarded, or physically disabled) or who conducted experiments on concentration camp prisoners without their consent. The Doctors Trial lasted 140 days. Eighty-five witnesses testified and almost 1,500 documents were introduced. Sixteen of the doctors charged were found guilty. Seven were executed.
18 Nuremberg Code 1947 Voluntary consent Results for the good of society, unprocurable by other means Avoid unnecessary suffering Based on scientific principles Conducted by scientifically qualified persons Interests of subject prevail over those of science and society Adequate information about risks and benefits Subjects are free to withdrawn Written informed consent obtained
19 Declaration of Helsinki (1964) Forms the ethical basis for all clinical research involving human subjects The guiding principle is that the physician must safeguard the health of their people
20 Why the need? Prior to 2004 the standards were guidelines and dual standards existed for pharmaceutical companies working to ICH GCP and academic institutions and the NHS working to MRC and GCP standards After 2004 ethical and scientific standards for the set-up and conduct of clinical research involving human subjects receiving medical products, became subject to the law
21 UK Regulations for Clinical Research Set of interwoven laws, guidelines and frameworks which govern UK clinical research Research Governance Framework The EU Directives and Statutory Instruments (GCP) ICH GCP Medicines for Human Use (Clinical Trials) Act 2006 The Mental Capacity Act (2005) Human Tissue Act (2004)
22 Learning from experience - Thalidomide First developed as an anticonvulsant drug. Had sedative properties, overdose simply caused prolonged sleep. Mid 1950s no guidelines for the development, production and marketing of medicinal products First marketed in Germany in 1957 as Contergral, in the UK in 1958 as Distaval Between 1958 and 1961 it was used by expectant mothers to control morning sickness
23 Learning from experience - Thalidomide Tragically many babies were born often with severe physical disabilities Estimated that 10,000 people worldwide were affected 1965 the first European Community Directive (65/65/EEC) was issued, in order to prevent a recurrence of this disaster which shook the health authorities and general public No medicinal product was ever to be marketed again without prior authorisation Medicines Act 1968
24 Standard 3 Competent and Capable Workforce Induction Risk management training Risk awareness training Supporting staff involved in an incident
25 Good Clinical Practice (GCP) is an international ethical & scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects 14 principles Legal requirement that everyone involved in clinical research has GCP training Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki and that the clinical trial data are credible
26 Responsibilities Clear delineation of responsibility: Sponsor Initiation, management and financing Initiation, management and financing, quality assurance, trial design, data, insurance or indemnity, safety reporting Chief Investigator One per member state. Ethics application Principal Investigator At individual sites Delegation of duties, safety reporting Sub-investigator Delegated responsibilities by the PI
27 Induction and Training Training logs CVs GCP certificates Set-up meetings Confidentiality Agreements Financial Disclosures
28 Delegation of duties Only perform activities in a clinical study which are delegated to them Identifies the individuals who have been delegated by the Principal Investigator, to carry out specific duties Competent and qualified Individuals are informed of their involvement and their required duties Delegation log signed by the Principal Investigator
29 Standard 4 Safe Environment Secure environment The deteriorating patient
30 Phases of drug development Phase 1: Usually paid volunteers Often healthy people, but can be patients Small numbers of participants Specialist units or hospitals Short term follow-up Intensive investigations
31 Phases of drug development Phase 2: Small numbers of patients Mainly in hospitals or specialised units Aim is to evaluate the dose and regimen for further studies Looking at the application of the drug Follow-up usually weeks may be months
32 Phases of drug development Phase 3: Evaluating new treatments in terms of use and safety Large numbers of patients 100s and 1,000s Patient group will have multiple problems Multi-centred Follow up usually 12 months or more Results should change or challenge practice
33 Phases of drug development Phase 4: Product has how been licensed by the regulatory authorities Continued monitoring and safety evaluation Extension of product license Usually long term
34 Key features of a clinical trial EudraCT (European Union Drug Regulating Authorities Clinical Trials)EU database for all clinical trials Study protocol Design of the study States, in detail, how the study is to be conducted Central research question defines the population Inclusion and exclusion criteria Reporting and reviewing procedures Safety monitoring committee
35 Safety Reporting Pharmacovigilance Continuous process of monitoring, evaluating and improving the safety of investigational medical products Adverse events Untoward medical occurrence Adverse reactions Untoward or unexpected adverse reaction Serious adverse events Resulting in, death, life threatening, hospitalisation, prolonged hospitalisation, disability or incapacity, congenital adnormality, other Serious unexpected adverse reaction Not listed in the investigational brochure
36 SAE Reporting Investigators responsibility to report all serious adverse events to sponsor and host organisation Sponsor responsible for ongoing evaluation Report immediately upon knowledge of event Not need to report non-serious and serious reactions identified in the protocol Ongoing safety issues still reported after study termination
37 Standard 5 Acute, Community and Non-NHS Providers Patient Information Consent Maintenance of equipment Record keeping Medicines management
38 Essential documents Study protocol amendments Investigator brochure Patient information sheet (version control) Consent form Regulatory applications, responses and approvals Delegation log Training log Correspondence Safety reporting
39 Patient Information Patient Information Sheet (PIS) Outlines all the details of the study Identifies potential hazards Contact details Can be 6 to 12 pages in length (!) Amendments Ensuring all information is shared with patients (rats!) Changes made to protocol - consent renewed (eg additional blood pressure readings) Version Control MHRA finding
40 Informed Consent A statutory requirement for clinical research Given freely May be in writing or orally in the presence of a witness Recorded - date and signature by authorised personnel The Mental Capacity Act 2005 states that every adult has the right to make his or her decisions, and must be assumed to have capacity to do so unless it is proved otherwise
41 Informed Consent Patients must have given informed consent to be included in a study No study procedures can take place until consent is obtained aims and methods of the study potential hazards know that involvement is voluntary can withdraw at any time information sheet
42 Source Data / Documentation All data collected for the study is verified in the source data medical notes Source data verification Double entry Case report form and the medical notes Investigations are reviewed and signed by a doctor eg blood tests, ECGs Archiving requirements If it is written down it didn t happen!
43 Medicines Management Standard Operating Procedures (SOPs) completed by pharmacy for every study Separate pharmacy file Prescribed via central system Checked against study ID and randomisation number Accountability log for all medications Returns carefully calculated
44 Safety Monitoring Internal checks External monitoring Data queries Source data verification Compliance checks
45 Food for thought 57,000 NHS litigation claims 6 claims associated with clinical research 2 claims successful Oncology studies (very complicated) Mistake regarding dosage calculation Cost less than ¼ million Conclusion: problem in the conduct of the study not the design (Reference: CLRN Conference 12 th March 2012)
46 Thank you!
TRIAL MASTER FILE- SPONSORED
gsop-06-04 - Management of TMF for ENHT/ WHHT Sponsored CTIMPs Page 1 of 16 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust TRIAL MASTER
More informationEU 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 informationUK Implementation of the EU Clinical Trial Directive 2001/20/EC:
UK Implementation of the EU Clinical Trial Directive 2001/20/EC: GCP Aspects. Dr. Colin Wilsher, FRQA. BARQA GCP Committee Chairman; & Pfizer Worldwide Development Quality Assurance. GIQAR, Roma, October
More 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 informationST. 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
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 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 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 informationAn introduction to Research Management and Governance (RM&G) in the NHS
An introduction to Research Management and Governance (RM&G) in the NHS Rachel Davis Assistant RM&G Project Manager Natassia Embury R&D Facilitator 14/04/2014 Delivering clinical research to make patients,
More 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 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 informationPHARMACY AND POISONS ORDINANCE (Cap. 138) APPLICATION FOR A CLINICAL TRIAL/MEDICINAL TEST CERTIFICATE
PHARMACY AND POISONS ORDINANCE (Cap. 138) APPLICATION FOR A CLINICAL TRIAL/MEDICINAL TEST CERTIFICATE PART A: TRIAL INFORMATION A1. Title of Clinical Trial (as stated in proposed Protocol) Protocol No.
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 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 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 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 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 informationGuidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device
Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device List of Contents Page 1. Introduction 1.1 The Medical Device Administrative Control System and the 3 proposed legislation
More informationMarie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager
Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name
More 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 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 informationTrust/Host Site Approval. Presented by: Anika Kadchha Research Governance Officer
Trust/Host Site Approval Presented by: Anika Kadchha Research Governance Officer Joint Research & Enterprise Office Training 19 th January Outline What is Research NHS Ethics (if required) Host Site Approval
More informationStandard Operating Procedures for Supporting Research Studies
Standard Operating Procedures for Supporting Research Studies February 2011 SOP Supporting Research Studies Page 1 of 13 1 Document Revision History Date Version Description Compiled by 31/01/11 0.1 First
More informationStaff Member Signature Date Direct Supervisor Related Mater Health Services Position Description attached. Theme Leader Signature Date.
POSITION DESCRIPTION Mothers and Babies Theme Position Title Division Position Purpose Position Scope Occupational Category and Level Reporting Relationship Review Date Next Review Due, Mothers and Babies
More informationINTERIM SITE MONITORING PROCEDURE
INTERIM SITE MONITORING PROCEDURE 1. PURPOSE The purpose of this SOP is to describe the interim monitoring procedures conducted at Institution, according to GCP and other applicable local regulations.
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 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 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 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 informationEssential Documentation and the Creation and Maintenance of Trial Master Files
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More 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 informationA Guide to Clinical Trials
A Guide to Clinical Trials For young people with cancer and their parents Children s Cancer and Leukaemia Group www.cclg.org.uk Original booklet produced in conjunction with the CCLG Patient Advocacy Committee.
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 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 informationWeb Meeting 12./13.12.2013: Study Close-out Procedures
SiLVER Study A prospective, randomized, open-labeled trial comparing sirolimuscontaining versus mtor-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma
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 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 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 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 information12.0 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,
More informationThe Trans-Tasman Early Warning System. Processes in Australia and New Zealand
The Trans-Tasman Early Warning System Processes in Australia and New Zealand Version 1.0 May 2013 About Medsafe Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is responsible
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 informationCLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE]
CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities
More informationThis SOP may also be used by staff from other NHS areas, or organisations, with prior agreement.
Standard Operating Procedure: SOP Number: SOP-QA-32 Version No: 1 Author: Date: (Gary Cooper, Named Sponsor Archivist, NHS Grampian and University of Aberdeen) 1-9-15 Approved by: Date: 1-9-15 (Professor
More 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 informationMedical Record Documentation
Good Clinical Practice & Medical Record Documentation Hanne Baekgaard Larsen & Terri Halverson Objectives: Understand the history behind and define some key components of Good Clinical Practice Identify
More informationSCIENTIFIC SUBSTANTIATION OF STANDARD OPERATIONAL PROCEDURES ROLE IN QUALITY ASSURANCE SYSTEM IN CLINICAL DRUG TRIALS
UDC 615:519.076 Dobrova V. Ye., Zupanets K. O., Ratushna K. L. National University of Pharmacy SCIENTIFIC SUBSTANTIATION OF STANDARD OPERATIONAL PROCEDURES ROLE IN QUALITY ASSURANCE SYSTEM IN CLINICAL
More informationDepartment of Health - Research Governance Framework (RGF)
LIVERPOOL JOHN MOORES UNIVERSITY SPONSORSHIP OF RESEARCH PROJECTS UNDER THE RESEARCH GOVERNANCE FRAMEWORK FOR HEALTH AND SOCIAL CARE April 2015 1 Background The Department of Health s Research Governance
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 informationOperational aspects of a clinical trial
Operational aspects of a clinical trial Carlo Tomino Pharm.D. Coordinator Pre-authorization Department Head of Research and Clinical Trial Italian Medicines Agency Mwanza (Tanzania), June 11, 2012 1 Declaration
More informationAct of 26 February 1998, containing rules on medical research involving human subjects (Medical Research (Human Subjects) Act)
[This is an unofficial translation and is provided for reference purposes only. It is not certified and it has not been authorised by the Dutch government; persons using this translation do so entirely
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 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 informationMedicine Safety Glossary
The following definitions are provided as a resource to supplement the information provided in the Medicine Safety Education section of the Pfizer.com Web site; they are not intended as a comprehensive
More informationDocument Title: Trust Approval and Research Governance
Document Title: Trust Approval and Research Governance Document Number: SOP034 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D
More 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 informationDisclaimer. Objectives 5/30/2016
Good Clinical Practice Informed Consent Training Presented by Jacqueline Everett Clinical Trial Governance Manager, Research Integrity Disclaimer The material in this presentation has been prepared by
More informationHollie Goddard Sr. IRB Coordinator McKesson Specialty Health
Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health We are responsible for acquiring, analyzing, and protecting medical information vital to providing quality patient care HIM professionals ensure
More informationStandard Operating Procedures (SOP) Research and Development Office
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Undertaking Risk Assessment of a Research and Development Project SOP Number: 33 Version Number: 1.0 Supercedes: N/A Effective
More 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 informationDocument Title: Project Management of Papworth Sponsored Studies
Document Title: Project Management of Papworth Sponsored Studies Document Number: SOP009 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G
More informationPATIENT INFORMATION SHEET Study name: CT morphology of lung parenchyma pre and post bariatric surgery: correlation with pulmonary function.
Version 2. 8.09.2011 Hammersmith Hospital Du Cane Rd London W12 0HS Tel: 020 8383 1000 www.imperial.nhs.uk PATIENT INFORMATION SHEET Study name: CT morphology of lung parenchyma pre and post bariatric
More informationGood Clinical Practice Guidelines
Good Clinical Practice Guidelines INTRODUCTION The history of Good Clinical Practice (GCP) statute traces back to one of the oldest enduring traditions in the history of medicine: The Hippocratic Oath.
More informationOverview of the national laws on electronic health records in the EU Member States National Report for Lithuania
Overview of the national laws on electronic health records in the EU Member States and their interaction with the provision of cross-border ehealth services Contract 2013 63 02 Overview of the national
More informationKeeping patients safe when they transfer between care providers getting the medicines right
PART 1 Keeping patients safe when they transfer between care providers getting the medicines right Good practice guidance for healthcare professions July 2011 Endorsed by: Foreword Taking a medicine is
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 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 informationRESEARCH AND DEVELOPMENT GAINING NHS RESEARCH PERMISSION FROM CARDIFF AND VALE UHB - GUIDANCE FOR RESEARCHERS. Research Governance Group
RESEARCH AND DEVELOPMENT GAINING NHS RESEARCH PERMISSION FROM CARDIFF AND VALE UHB - GUIDANCE FOR RESEARCHERS Reference No: UHB 074 Version No: 5 Previous Trust / LHB Ref No: N/A Documents to read alongside
More informationR&D Administration Manager. Research and Development. Research and Development
Document Title: Document Number: Patient Recruitment SOP031 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration Manager,
More informationMedical College of Georgia SOP NUMBER: 03 INVESTIGATIONAL DRUG HANDLING Version Number: 1.0, 1.1 Effective Date: 09/12/06, 08/02/10, 3/2/11
Effective Date: 09/12/06, 08/02/10, 3/2/11 Title: 1.0 OBJECTIVE: 1.1 This SOP describes the methods and policies for: Handling investigational drug Dispensing investigational drug 1.2. This procedure applies
More informationDorset Research Consortium. Research Governance: A handbook for Researchers in Dorset
Dorset Research Consortium Research Governance: A handbook for Researchers in Dorset DRC Version 1 dated 25 th July 2012 Research Governance: The Basics... 4 What is Research Governance?... 4 The Research
More informationTEMPLATE DATA MANAGEMENT PLAN
TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager
More informationThe 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
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 informationData Management in Clinical Trials
Data Management in Clinical Trials Introduction to the Principles and Practice of Clinical Research February 19, 2013 Diane St. Germain, RN, MS Nurse Consultant Division of Cancer Prevention National Cancer
More informationSharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com
SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,
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 informationDoes my project require review by a Research Ethics Committee?
National Research Ethics Service Does my project require review by a Research Ethics Committee? This algorithm is designed to assist researchers, sponsors and R&D offices in determining whether a project
More 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 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 informationDocument 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
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 informationJoint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009
Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 1 Updated November 10, 2009 The innovative pharmaceutical industry 2 is committed to the transparency
More 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 information