GCP Basics - refresher

Size: px
Start display at page:

Download "GCP Basics - refresher"

Transcription

1 p. 01 GCP Basics - refresher

2 Agenda: p. 02 Brief History of GCP GCP Regulations Principles of ICH E6 Sponsor Responsibilities Computer Systems Common Compliance Issues

3 Brief History of GCP 3

4 Brief History of GCP Declaration of Helsinki, written by the World Medical Association (WMA), an international organisation representing physicians. Incorporated the Nuremberg code Provided the highest ethical standards at that time

5 Brief History of GCP International Conference on Harmonisation (ICH), consisting of authorities of Europe, US and Japan and experts from pharmaceutical industries. Led to an international, uniform standard to accept the results of clinical trials, as long as they are conducted according to the ICH-GCP guidelines.

6 Brief History of GCP ICH GCP evolved from an economic incentive to a legal requirement in Europe Directive 2001/20/EC Commonly known as The Clinical Trials Directive Came into force in all European member states in May Directive 2005/28/EC Commonly known as The GCP Directive Came into force in all European member states in Jan 2006

7 Brief History of GCP Regulation 536/2014 The Clinical Trial Regulation Applies from May 28th 2016 (at the earliest*) Will be available by October 2018.(according to EMA homepage)

8 GCP Regulations 8

9 GCP Regulations 9 Regulations relating to GCP - US Electronic Records; Electronic Signatures (21 CFR Part 11) Protection of Human Subjects (Informed Consent) (21 CFR Part 50) Financial Disclosure by Clinical Investigators (21 CFR Part 54) Institutional Review Boards (21 CFR Part 56) Investigational New Drug Application (21 CFR Part 312) Foreign Clinical Trials not conducted under an IND (21 CFR Part ) Forms 1571 (Investigational New Drug Application) and 1572 (Statement of Investigator) Applications for FDA Approval to Market a New Drug (21 CFR Part 314) Bioavailability and Bioequivalence Requirements (21 CFR Part 320) Applications for FDA Approval of a Biologic License (21 CFR Part 601)

10 GCP Regulations 10 Regulations relating to GCP - EU Directive 2001/20/EC implementation of GCP in conduct of clinical trials on medicinal products for human use Directive 2005/28/EC detailed guidelines for GCP as regards IMP for human use Directive 2003/94/EC principles and guidelines of GMP in respect of medicinal products for human use and IMP for human use Regulation 536/2014 (not yet applicable)

11 GCP Regulations 11 Regulations relating to GCP - RoW..

12 Good Clinical Practice (GCP) 12 ICH E6 provides a unified standard for the European Union (EU), Japan, and the United States facilitates the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions applicable to drug and biological products

13 What does it mean? p. 013 The Code of Federal Regulation is law in US and non-compliance can in worst case be handled as a criminal offence In Europe the directives and associated GCP regulations have been (country specific) laws since 2004 In Japan GCP is law as stated in MHW Ministerial Ordinance No.28 (Mar.27,1997), No.106 (Jun.12, 2003), No.72 (Mar.31, 2006), No.24 (Feb.29, 2008) & No 161 (Dec 28, 2012)

14 ICH Guideline for GCP 14 Introduction states: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing 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. and by inference, the converse is also true!

15 ICH Guideline for GCP 15 Table of Contents 1. Glossary 2. The Principles of ICH GCP 3. Institutional Review Board / Independent Ethics Committee 4. Investigator 5. Sponsor 6. Clinical Trial Protocol and Protocol Amendments 7. Investigator s Brochure 8. Essential Documents for the Conduct of a Clinical Trial

16 Good Clinical Practice 16 The principles of ICH GCP

17 The Principles of ICH GCP Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements.

18 The Principles of ICH GCP Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

19 The Principles of ICH GCP The rights, safety and well being of trial subjects shall prevail over the interests of science and society: Informed Consent Ethics Committees Records of Adverse Events

20 The Principles of ICH GCP The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial: Investigator s Brochure

21 The Principles of ICH GCP Clinical trials should be scientifically sound and described in a clear, detailed protocol: Input from external medical experts Input from internal medical experts and statisticians Reviewed and accepted by regulatory authorities

22 The Principles of ICH GCP A trial should be conducted in accordance with the protocol that has received prior institutional review board (IRB) / independent ethics committee (IEC) approval / favourable opinion: Regulatory Green Light

23 The Principles of ICH GCP The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist: Principal Investigator (PI) Sub-investigator

24 The Principles of ICH GCP Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective tasks: Maintain: Job description, CV, Training record. Perform: Activities in which you are trained and for which you have documentation.

25 The Principles of ICH GCP Freely given informed consent should be obtained from every subject prior to clinical trial participation. Information should contain details concerning Data Privacy and potential transfer of data outside EU

26 The Principles of ICH GCP All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification: ALCOACC Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent Maintenance of Trial and Site Master Files Archiving Validation

27 The Principles of ICH GCP The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements: Patient ID Numbers Data protection / HIPAA

28 The Principles of ICH GCP Investigational products should be manufactured, handled and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol: Technical Green Light QP release for European IMP

29 The Principles of ICH GCP Systems with procedures that assure the quality of every aspect of the trial should be implemented: Quality Control Monitoring Quality Assurance / Auditing And.. anything else that is necessary!

30 Good Clinical Practice 30 Sponsor Responsibilities

31 Sponsor QA and QC The Sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded) and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s). Follow current versions of SOPs

32 Sponsor QA and QC Quality Control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.

33 Sponsor Contract Research Organisation A sponsor may transfer any or all of the sponsor s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control. Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.

34 Sponsor Trial Design The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports.

35 Sponsor Trial Management etc. When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should: Ensure and document that the system is validated Maintain SOPs for using these systems Ensure an audit trail is maintained Maintain a security system to prevent unauthorised access Maintain a list of individuals who are authorised to make data changes Maintain adequate backup of the data Safeguard the blinding.

36 Sponsor Trial Management etc. The Sponsor, or other owners of the data, should retain all of the sponsor-specific essential documents pertaining to the trial. Trial Master File (8.1.) Any or all of the essential documents may be subject to, and should be available for, audit by the sponsor s auditor or inspection by the regulatory authorities. Maintain TMF up to date at all times

37 Sponsor 5.5.6, -Trial Master File 37 Keep your documents in control!

38 Sponsor Investigator Selection 38 The sponsor should obtain the investigator's agreement: to conduct the trial in compliance with GCP, with the applicable regulatory requirement(s) and with the protocol agreed to by the sponsor and given approval/favourable opinion by the IRB/IEC and document that the system is validated to comply with procedures for data recording/reporting to permit monitoring, auditing and inspection and to retain the trial related essential documents until the sponsor informs the investigator/institution these documents are no longer needed. The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

39 Sponsor & Investigator FDA Form

40 Sponsor IMP: Manufacturing, Packaging, Labelling & Coding The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices for product infusion, if any. The sponsor should inform all involved parties (e.g. monitors, investigators, pharmacists, storage managers) of these determinations.

41 Sponsor IMP: Manufacturing, Packaging, Labelling & Coding In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.

42 Sponsor IMP: Supplying and Handling The sponsor should: Ensure timely delivery of investigational product(s) to the investigator(s). Maintain records that document shipment, receipt, disposition, return, and destruction of the investigational product(s) Maintain a system for retrieving investigational products and documenting this retrieval (e.g. for deficient product recall, reclaim after trial completion, expired product reclaim). Maintain a system for the disposition of unused investigational product(s) and for the documentation of this disposition.

43 Sponsor Safety Information The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC s approval/favorable opinion to continue the trial.

44 Sponsor Monitoring The purposes of trial monitoring are to verify that: The rights and well-being of human subjects are protected The reported trial data are accurate, complete and verifiable from source documents The conduct of the trial is in compliance with the currently approved protocol/amendment, with GCP and with applicable regulatory requirements

45 Sponsor Monitoring The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial. [ ]

46 Sponsor Monitoring Monitor s Responsibilities

47 Sponsor Noncompliance Noncompliance with the protocol, SOPs, GCP and/or applicable regulatory requirements by an investigator or by members of the sponsor s staff should lead to prompt action by the sponsor to secure compliance.

48 Sponsor Noncompliance If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of the investigator/institution, the Sponsor should terminate the investigator/institution s participation in the trial, and promptly notify the regulatory authorities.

49 Sponsor Clinical Trial/Study Reports Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s).

50 Sponsor Clinical Trial/Study Reports The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3). (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports specifies that abbreviated study reports may be acceptable in certain cases.)

51 Computer Systems 51

52 Computer Systems CFR part 11 electronic records; electronic signatures, 1997 Computerized Systems used in Clinical Investigations, FDA, 2007 Volume 10 of The rules governing medicinal products in the European Union, chapter IV, annex III computer systems, Eudralex 2008 Good practices for computerised systems in regulated "gxp" environments, PIC/S, 2007

53 Computer Systems CFR Part 11 Requires: procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine.

54 Computer Systems CFR Part 11 Requires: Validation of Systems Protection of records Limiting access to authorised individuals Secure audit trails Education, training and experience Policies to hold individuals accountable Documentation controls

55 GCP Compliance Issues 55

56 GCP Compliance Issues 56 Procedures The necessary procedures to secure the quality of every aspect of the trials shall be complied with.

57 GCP Compliance Issues 57 Procedures Document Control: Version numbering and traceability Which version of the document was effective on this date? Archiving, retrieval and prevention of inadvertent use Can you provide me with the original, signed document in this version? Awareness and distribution Was the person conducting the activity following the effective version of the document on this date?

58 GCP Compliance Issues 58 Procedures Compliance Current, effective procedures shall be complied with. Procedures shall be maintained up-to-date. Build-in flexibility when writing procedures. Flexibility not ambiguity Document unavoidable non-compliance. (and avoid avoidable non-compliance!)

59 GCP Compliance Issues 59 Procedures Awareness Each person must be able to document contemporary awareness of procedures relevant to their job function. What is relevant?

60 GCP Compliance Issues 60 Training Shall be consistent with the person s job function. Shall be maintained up-to-date. Shall be documented. Shall be planned, especially in connection with internal transfers, promotions and extended absence.

61 Good Clinical Practice 61 Good Clinical Practice is a set of quality requirements for clinical trials that provides assurance that the rights, safety and well-being of patients are protected, and that the results of the clinical trials are credible.

62 Good Clinical Practice (GCP) 62

Annex IV to guidance for the conduct of good clinical practice inspections sponsor and CRO

Annex IV to guidance for the conduct of good clinical practice inspections sponsor and CRO 23 August 2017 EMA/431267/2016 Annex IV to guidance for the conduct of good clinical practice inspections sponsor Adopted by GCP Inspectors Working Group (GCP IWG) 29 November 2017 Keywords GCP inspection,

More information

Quality Assurance in Clinical Trials

Quality Assurance in Clinical Trials Quality Assurance in Clinical Trials Doctor Catherine CORNU, Lyon clinical Investigation Centre EUDIPHARM December 5th, 2011 1 Introduction: quality in clinical research in human subjects Regulatory requirements:

More information

The European Medicines Agency Inspections ANNEX IV TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA:

The European Medicines Agency Inspections ANNEX IV TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: The European Medicines Agency Inspections London, 20 September 2007 EMEA/INS/GCP/197221/2005 Procedure no.: INS/GCP/3/IV ANNEX IV TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: SPONSOR

More information

Good Clinical Practice. Martin Rose, MD, JD February 8, 2018 ASQ

Good Clinical Practice. Martin Rose, MD, JD February 8, 2018 ASQ Good Clinical Practice Martin Rose, MD, JD February 8, 2018 ASQ Disclaimer The views expressed in this presentation are those of the presenter and do not necessarily represent the official position of

More information

How did it evolve? o Public disasters, serious fraud and abuse of human rights. o Trials of War criminals-nuremberg code 1949

How did it evolve? o Public disasters, serious fraud and abuse of human rights. o Trials of War criminals-nuremberg code 1949 ICH GCP Overview What is ICH? ICH is a joint initiative involving both the regulators and the industry as equal partners in the scientific and technical discussions of the testing procedures which are

More information

IMP Management and Accountability

IMP Management and Accountability This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document

More information

Research Professionals Network Workshop Series

Research Professionals Network Workshop Series Research Professionals Network Workshop Series SO YOU THINK YOU KNOW GCP? Mary-Tara Roth Director, CRRO mtroth@bu.edu Gina Daniels Human Research Quality Manager gdaniels@bu.edu What is [ICH] GCP? an

More information

GUIDELINE FOR GOOD CLINICAL PRACTICE TABLE OF CONTENTS

GUIDELINE FOR GOOD CLINICAL PRACTICE TABLE OF CONTENTS INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE i GUIDELINE FOR GOOD CLINICAL PRACTICE ICH Harmonised Tripartite Guideline Having reached

More information

ESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL

ESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL ESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL THIS INFORMATION SHEET (ISR-RG-014) HAS BEEN TAKEN DIRECTLY FROM THE ICH- GUIDELINE* WITH ADDITIONAL COMMENTS ADDED BY THE RESEARCH GOVERNANCE

More information

STANDARD OPERATING PROCEDURE. STH Researcher. Investigator Site File

STANDARD OPERATING PROCEDURE. STH Researcher. Investigator Site File Research Department STANDARD OPERATING PROCEDURE STH Researcher SOP History CSUH 00/016 SOP Number A116 Created STH Research Department (TL) Reviewed by STH Research Department (AL) 06 August 2009 Superseded

More information

Good Clinical Practice

Good Clinical Practice Dublin Academic Medical Centre Good Clinical Practice Patrick Murray, MD, FASN, FRCPI Professor, University College Dublin, Mater Misericordiae University Hospital, Dublin, Ireland patrick.murray@ucd.ie

More information

ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL Assemble Essential Documents in Trial Master File (TMF) Appendix 1 ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 8.2 Before the Clinical Phase of the Trial Commences During this planning stage

More information

Good Clinical Practice Inspections Expectations for Compliance with Sponsor Responsibilities, Part II

Good Clinical Practice Inspections Expectations for Compliance with Sponsor Responsibilities, Part II Good Clinical Practice Inspections Expectations for Compliance with Sponsor Responsibilities, Part II IMB Clinical Trials Seminar, 19 th June 2012 Ms. Sinead Curran GCP/Pharmacovigilance Inspector 22/06/2012

More information

Conducted Under an IND to Support a

Conducted Under an IND to Support a Using Foreign Clinical Trial Data not Conducted Under an IND to Support a US Application PDA Midwest Chapter Meeting March 15, 2018 2013 2017 Regulatory Compliance Associates Inc. All Rights Reserved.

More information

COMMON MARKET OF MEDICINES OF THE EURASIAN ECONOMIC UNION: RULES OF GOOD CLINICAL PRACTICE AND GOOD LABORATORY PRACTICE

COMMON MARKET OF MEDICINES OF THE EURASIAN ECONOMIC UNION: RULES OF GOOD CLINICAL PRACTICE AND GOOD LABORATORY PRACTICE COMMON MARKET OF MEDICINES OF THE EURASIAN ECONOMIC UNION: RULES OF GOOD CLINICAL PRACTICE AND GOOD LABORATORY PRACTICE www.gratanet.com Among other regulations aimed at the implementation of the Agreement

More information

Clinical Research & ICH GCP E6(R2) (Basic / Refresher Training):

Clinical Research & ICH GCP E6(R2) (Basic / Refresher Training): Clinical Research & ICH GCP E6(R2) (Basic / Refresher Training): Principles of GCP, Investigator Responsibilities, Essential Documents v3 01-Feb-2017 Objectives To provide refresher training on ICH GCP

More information

Agenzia Italiana del Farmaco

Agenzia Italiana del Farmaco Agenzia Italiana del Farmaco The Italian Legislation and the work of the Italian Medicines Agency (AIFA) in the field of ethics of Clinical Trials Umberto Filibeck AIFA Head of GCP Inspectorate and GCP

More information

ICH E6 Guideline R 2 優良臨床試驗指引修改及增編附錄

ICH E6 Guideline R 2 優良臨床試驗指引修改及增編附錄 ICH E6 Guideline R 2 優良臨床試驗指引修改及增編附錄 Mandy Liu 劉文婷 COQM/ Boehringer Ingelheim Taiwan Ltd Former Team leader GCP inspection team/ CDE Member of Expert Working Group of ICH E6 2016.11.23 Statement of the

More information

The interface between Good Clinical Practice and Good Manufacturing Practice

The interface between Good Clinical Practice and Good Manufacturing Practice 1 The interface between Good Clinical Practice and Good Manufacturing Practice your partner in compliance 1 The interface between GCP and GMP Generally, studies are designed and planned by physicians who

More information

Investigator s Responsibility

Investigator s Responsibility Investigator s Responsibility Introduction Investigator s Qualifications Clinical Trial Agreement Adequate Resources Medical Care of Trial Subjects Communication with IRB/IEC Study Initiation Patient Recruitment

More information

IDENTIFYING & MANAGING GCP COMPLIANCE RISKS FOR THE PHARMACEUTICAL, BIOTECH & DEVICE INDUSTRIES

IDENTIFYING & MANAGING GCP COMPLIANCE RISKS FOR THE PHARMACEUTICAL, BIOTECH & DEVICE INDUSTRIES IDENTIFYING & MANAGING GCP COMPLIANCE RISKS FOR THE PHARMACEUTICAL, BIOTECH & DEVICE INDUSTRIES Karen Weaver Epstein, Becker & Green Health Care & Life Sciences Practice APPLICABLE REGULATIONS 21 CFR 312

More information

Clinical Research: A Multifaceted Discipline

Clinical Research: A Multifaceted Discipline Clinical Research: A Multifaceted Discipline Anuradha Kulkarni a, Arun Bhatt b* a Senior Associate - Medical & Regulatory Affairs, Clininvent Research Pvt Ltd, A-302, Everest Chambers, Marol Naka, Andheri

More information

1.4 Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.

1.4 Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. 1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended

More information

INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE

INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH) ICH HARMONISED GUIDELINE INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE

More information

OFFICE FOR RESEACH PROCEDURE. Site Initiation and Close-out

OFFICE FOR RESEACH PROCEDURE. Site Initiation and Close-out OFFICE FOR RESEACH PROCEDURE Site Initiation and Close-out 1. Purpose: To describe the procedures related to site initiation and close-out of a clinical trial. 2. Scope: Applicable to all phases of clinical

More information

INSPECTION OF INDEPENDENT ETHICS COMMITTEES (IEC) The Italian Experience

INSPECTION OF INDEPENDENT ETHICS COMMITTEES (IEC) The Italian Experience INSPECTION OF INDEPENDENT ETHICS COMMITTEES (IEC) The Italian Experience Umberto Filibeck Former Head of AIFA GCP Inspectorate and GCP Promotion Unit UNICRI Consultant for Projects on GCP of CTs in developing

More information

Standard Operating Procedures Guidelines for Good Clinical Practice

Standard Operating Procedures Guidelines for Good Clinical Practice SOP # CRSC-105 Effective Date 10-22-2013 Version # 1 Version Date 7-30-2013 Standard Operating Procedures Guidelines for Good Clinical Practice Purpose: This SOP outlines the steps required to follow FDA

More information

Human Research Protection Program Policy

Human Research Protection Program Policy Adopted: 11/2005 Revised: 03/2014 Page: 1 of 6 RIGHTS AND RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS IN HUMAN SUBJECTS RESEARCH POLICY Each research study will have a Principal Investigator (PI) and may

More information

Overview of Privacy Requirements and Compliance Issues in International Clinical Trials

Overview of Privacy Requirements and Compliance Issues in International Clinical Trials Overview of Privacy Requirements and Compliance Issues in International Clinical Trials Health Care Compliance Association Research Compliance Conference October 18-20, 2009 Minneapolis, MN 1 Today s Presenters

More information

Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance

Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance ICH April 1996 Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance Additional copies are available from: the Drug

More information

STANDARD OPERATING PROCEDURE

STANDARD OPERATING PROCEDURE STANDARD OPERATING PROCEDURE Title Reference Number Archiving and the Destruction of Records SOP-RES-028 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January

More information

GCP INSPECTION FINDINGS Singapore Research Ethics Conference 2018

GCP INSPECTION FINDINGS Singapore Research Ethics Conference 2018 1 GCP INSPECTION FINDINGS Singapore Research Ethics Conference 2018 Sumitra Sachidanandan GCP Inspection Consultant Clinical Trials Branch Health Products Regulation Group Health Sciences Authority Singapore

More information

RESEARCH AUDIT Standard Operating Procedure

RESEARCH AUDIT Standard Operating Procedure Reference Number: UHB 236 Version Number: 2 Date of Next Review: 17 th Oct 2020 Previous Trust/LHB Reference Number: N/A RESEARCH AUDIT Standard Operating Procedure Introduction and Aim As a legal Sponsor

More information

Standard Operating Procedure

Standard Operating Procedure Standard Operating Procedure Title: Clinical Site Monitoring Status: PRIVATE Author Name: Audrey Strader Approver Name: Christine Kubiak Document no.: CSM 02 Effective date: 11/01/2016 Review Date (if

More information

ICH Topic E 6 (R1) Guideline for Good Clinical Practice. Step 5 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (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) 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 information

Compliance and Quality Monitoring: What, Why, When, and How

Compliance and Quality Monitoring: What, Why, When, and How Compliance and Quality Monitoring: What, Why, When, and How Jeanna Julo, BA, BA, CCRP Assistant Director, Clinical Data Management & Quality Controls, Auditing & Training Research Institute, University

More information

1 The Clinical Research Coordinator (CRC)... 1

1 The Clinical Research Coordinator (CRC)... 1 TABLE OF CONTENTS Dedication... iii Introduction... xi 1 The Clinical Research Coordinator (CRC)... 1 Role and Responsibilities of the CRC...1 Personality and Skills... 3 Where Do CRCs Work?... 3 CRC Responsibilities...

More information

ICH/GCP Guidelines Self-Evaluation Questionnaire

ICH/GCP Guidelines Self-Evaluation Questionnaire THE QUALITY ASSURANCE JOURNAL, VOL. 2, 74 82 (1997) ICH/GCP Guidelines Self-Evaluation Questionnaire The questionnaire below has been designed as a diverting, internal training tool by a group of employees

More information

Good Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations

Good Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations Good Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations 9th edition of Synevo Clinical Research Symposium. 17 th November 2017 Bucharest.

More information

Audit and Regulatory Inspection Nopanan Yaibuathes Clinical Research and Compliance Manager Roche Thailand Ltd.

Audit and Regulatory Inspection Nopanan Yaibuathes Clinical Research and Compliance Manager Roche Thailand Ltd. Audit and Regulatory Inspection Nopanan Yaibuathes Clinical Research and Compliance Manager Roche Thailand Ltd. Copyright 2009 - Pharmaceutical Research & Manufacturers Association 1 Overview Audit ICH-GCP,

More information

ORC Sponsor-Investigator IDE Checklist

ORC Sponsor-Investigator IDE Checklist A sponsor-investigator assumes BOTH investigator and sponsor responsibilities as outlined in the FDA Code of Federal Regulations 21CFR812. This means that such investigators have additional responsibilities.

More information

"From Bedside to Bench and Back: regulatory requirements for collaborations between pharma industry and academia

From Bedside to Bench and Back: regulatory requirements for collaborations between pharma industry and academia "From Bedside to Bench and Back: regulatory requirements for collaborations between pharma industry and academia Damir Hamamdžić D.V.M., Ph.D. Office of Research Regulatory Affairs Rutgers University RWJMS

More information

Investigator Site File Index (Medical Devices)

Investigator Site File Index (Medical Devices) Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol (Clinical Investigation Plan) Current version plus all previous versions (or provide file note

More information

etmf A Regulators Perspective Paula Walker, GCP Operations Manager & Senior GCP Inspector

etmf A Regulators Perspective Paula Walker, GCP Operations Manager & Senior GCP Inspector etmf A Regulators Perspective Paula Walker, GCP Operations Manager & Senior GCP Inspector Agenda EU Legislation and Guidance News/Updates relating to TMF Structure and Content of e/tmf Inspecting etmfs

More information

Once notified of the end of trial, a Research Manager, on behalf of the Sponsor, will contact the CI to arrange a close down monitoring visit.

Once notified of the end of trial, a Research Manager, on behalf of the Sponsor, will contact the CI to arrange a close down monitoring visit. 1. INTRODUCTION This SOP has been produced in accordance with the requirements of The Medicines for Human Use (Clinical Trials) Regulations 2004, Medicines for Human Use (Clinical Trials) Amendment Regulations

More information

MRC. 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. 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 information

EUROPEAN INDUSTRIAL PHARMACISTS GROUP. Guidance on CPD for QUALIFIED PERSONS

EUROPEAN INDUSTRIAL PHARMACISTS GROUP. Guidance on CPD for QUALIFIED PERSONS EUROPEAN INDUSTRIAL PHARMACISTS GROUP Guidance on CPD for QUALIFIED PERSONS EIPG Guidance on CPD for QP Continuing Professional Development for Qualified Persons, Technical Directors and other Responsible

More information

EU Annex 11 US FDA 211, 820, 11; other guidelines Orlando López 11-MAY-2011

EU Annex 11 US FDA 211, 820, 11; other guidelines Orlando López 11-MAY-2011 Principle. a. This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill

More information

GCP/Clinical Investigation in Japan

GCP/Clinical Investigation in Japan GCP/Clinical Investigation in Japan 27-28 August, 2018 Shinwa Shibata Office of Non-clinical and Clinical Compliance Pharmaceuticals and Medical Devices Agency 1 Today s Agenda 1. Japanese-GCP (J-GCP)

More information

Investigator Site File Index (CTIMP)

Investigator Site File Index (CTIMP) Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol Current version plus all previous versions (or provide file note to detail location of previous

More information

Data Quality and Integrity: From Clinical Monitoring to Marketing Approval

Data Quality and Integrity: From Clinical Monitoring to Marketing Approval Data Quality and Integrity: From Clinical Monitoring to Marketing Approval Nancy Detich, Ph.D., C.C.R.P. Senior Scientist, Clinical Strategy 18 November 2010 1 Objectives Identify the importance of accuracy,

More information

Topics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities

Topics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities Topics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities audit, audit report and CAPA 1. QUALITY must be guaranteed,

More information

ICH Topic E 6 Guideline for Good Clinical Practice NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) *

ICH 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 ICH Topic E 6 Guideline for Good Clinical Practice Step 5, Consolidated Guideline 1.5.96 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95)

More information

GCP Convergence Improves Transportability of Medical Device Clinical Data

GCP Convergence Improves Transportability of Medical Device Clinical Data GCP Convergence Improves Transportability of Medical Device Clinical Data By Harmonization-by-Doing Working Group 4 The safety, performance and effectiveness of medical devices are often evaluated by well-controlled

More information

Ethics Committees/IRBs Today: Challenges for Efficiency and Quality

Ethics Committees/IRBs Today: Challenges for Efficiency and Quality Marjorie A. Speers, Ph.D. President and CEO Ethics Committees/IRBs Today: Challenges for Efficiency and Quality Copyright 2013 AAHRPP All rights reserved Goal Clinical Research Globally Access to patients

More information

STANDARD OPERATING PROCEDURE

STANDARD OPERATING PROCEDURE STANDARD OPERATING PROCEDURE Title Reference Number Maintaining Study Files SOP-RES-014 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s)

More information

Compliance Program Guidance Manuals (CPGMs) -1-

Compliance Program Guidance Manuals (CPGMs) -1- Inspector s Preparation for a CI Inspection: FDA Compliance Program & the Records Inventory Jean Toth-Allen, Ph.D. APEC GCP Inspection Workshop May 28, 2008 Compliance Program Guidance Manuals (CPGMs)

More information

Stephanie Gentilin, CCRA

Stephanie Gentilin, CCRA Elements of Clinical Trial Quality Assurance Stephanie Gentilin, CCRA Regulatory Coordinator SCTR SUCCESS Center QA Monitor NIDA Monitor s Responsibilities ICH E6 Section 5.18 Overall Purpose of Monitoring

More information

STANDARD OPERATING PROCEDURE FOR RESEARCH. 17. Study Close Down

STANDARD OPERATING PROCEDURE FOR RESEARCH. 17. Study Close Down Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 17. Study Close Down According to ICH Good Clinical Practice (GCP)

More information

ROLE OF THE RESEARCH COORDINATOR Investigational New Drug Application-Sponsor Responsibilities 21CFR Part , subpart D

ROLE OF THE RESEARCH COORDINATOR Investigational New Drug Application-Sponsor Responsibilities 21CFR Part , subpart D Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Investigational

More information

Author Signature: Date: 10 October 2017 The author is signing to confirm the technical content of this document

Author Signature: Date: 10 October 2017 The author is signing to confirm the technical content of this document SOP Title: Investigator s Brochure Content, Design, Amendments, Filing & Distribution Author: Clinical Research and Development Office (CRDO) Author Signature: Date: 10 October 2017 The author is signing

More information

Applicability of US Regulations to Canadian Research

Applicability of US Regulations to Canadian Research Applicability of US Regulations to Canadian Research Mary Kate Needler Capital District Health Authority Halifax, Nova Scotia, Canada N2 Stakeholder Meeting August 18, 2014 MK s Conventions: 1. US Regulation

More information

Investigational Medicinal Product (IMP) Management Standard Operating Procedure

Investigational Medicinal Product (IMP) Management Standard Operating Procedure Reference Number: UHB 040 Version Number: 3 Date of Next Review: 26 Apr 2019 Previous Trust/LHB Reference Number: T 363 Standard Operating Procedure Introduction and Aim This procedure is written to support

More information

Date: 21 st May 2014 Version: 5 Page 1 of 11. Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May 2014

Date: 21 st May 2014 Version: 5 Page 1 of 11. Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May 2014 Date: 21 st May 2014 Version: 5 Page 1 of 11 STANDARD OPERATING PROCEDURE FOR MONITORING CLINICAL TRIALS (NWORTH 3.07) Approvals Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May

More information

I. Purpose. II. Definitions. Last Approval Date

I. Purpose. II. Definitions. Last Approval Date Investigational Drugs and Biologics Page 1 of 13 I. Purpose The purpose of this policy is to establish procedures for the proper control, storage, use and handling of investigational drugs and biologics

More information

EU Annex 11 US FDA , (g), (i), 11 Orlando López 09-APR

EU Annex 11 US FDA , (g), (i), 11 Orlando López 09-APR Principle. a. This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill

More information

3.1. Overall Principal Investigator (PI), who holds the IND and is the Sponsor.

3.1. Overall Principal Investigator (PI), who holds the IND and is the Sponsor. SOP #: RCO-100 Page: 1 of 11 1. POLICY STATEMENT: An Overall Principal Investigator (PI) who holds an Investigational New Drug Application (IND) and who is the Sponsor of the research has additional responsibilities

More information

NOTICE Our file number:

NOTICE Our file number: February 2, 2004 NOTICE Our file number: 04-102318-522 ICH 1 Guidance E6: Good Clinical Practice: Consolidated guideline ERRATUM in English and French The final English and French versions of the Health

More information

Conducting Clinical Trials of Investigational Medicinal Products

Conducting Clinical Trials of Investigational Medicinal Products Title: Outcome Statement: Written By: Reviewed By: Conducting Clinical Trials of Investigational Medicinal Products Researchers in the Trust and research partners will be informed about the procedures

More information

Clinical Trials application process, legislation & guidelines

Clinical Trials application process, legislation & guidelines Clinical Trials application process, legislation & guidelines IMB Clinical Trials Seminar 19 th June 2012 Elaine Breslin MB BCh (NUI), PhD, FRCPI Clinical Assessment Manager 19/06/2012 Slide 1 IMB Mission

More information

European Academy of Hospital Pharmacy Biotechnology Educational Summit. Clinical trials David Gerrett (Acknowledgment Mark Howells)

European Academy of Hospital Pharmacy Biotechnology Educational Summit. Clinical trials David Gerrett (Acknowledgment Mark Howells) European Academy of Hospital Pharmacy Biotechnology Educational Summit Clinical trials David Gerrett (Acknowledgment Mark Howells) Objectives Have an appreciation and overview of clinical trials Understand

More information

\\NAS1\George\Docs\SoCRA\CCRP communications\study guide management

\\NAS1\George\Docs\SoCRA\CCRP communications\study guide management Five Content Areas Percent of Scored Test Items (Range) in Each Area This table shows the percent of scored test questions that are included in each major content area. Five Content Areas Ethical Principles

More information

Standard Operating Procedures (SOP) Research and Development Office

Standard Operating Procedures (SOP) Research and Development Office Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Essential Documentation and Creation and Maintenance of Trial Master File SOP Number: 13 Version Number: 2.0 Supercedes:

More information

Document Number: SOP/RAD/SEHSCT/003 Page 1 of 9 Version 2.0

Document Number: SOP/RAD/SEHSCT/003 Page 1 of 9 Version 2.0 Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Archiving Study Documents SOP Number: 3 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August

More information

GCP Refresher and GCP/GCDMP Trends. in the CTN. Denise King, MS, RD, CCRA & Lauren Yesko, BS. Presented by:

GCP Refresher and GCP/GCDMP Trends. in the CTN. Denise King, MS, RD, CCRA & Lauren Yesko, BS. Presented by: GCP Refresher and GCP/GCDMP Trends Presented by: in the CTN Denise King, MS, RD, CCRA & Lauren Yesko, BS CTN WEB SEMINAR SERIES: A FORUM TO EXCHANGE RESEARCH KNOWLEDGE Produced by: CTN Training This training

More information

Clinical Trials & Regulatory

Clinical Trials & Regulatory Clinical Trials & Regulatory Infrastructures t MENA Raeda Mustafa, B.Sc.Pharm., MBA, CCRA, CCRC/ Molecule CRO Updates to ICH GCP E6 (R2) and BE Studies 3rd MENA Regulatory Conference on Bioequivalence,

More information

Impact of the transposition of the European Clinical Trials Directive. CEMO, Paris 17 November 2004

Impact of the transposition of the European Clinical Trials Directive. CEMO, Paris 17 November 2004 Impact of the transposition of the European Clinical Trials Directive CEMO, Paris 17 November 2004 Dr Martine Dehlinger-Kremer VP Regulatory Affairs International Agenda Overview of key areas of Directive

More information

Standard Operating Procedure for Archiving

Standard Operating Procedure for Archiving Standard Operating Procedure for Archiving SOP name: NWORTH07/19 archiving Version 2 Authorship Team: Angela Gliddon & Rhiannon Whitaker Meeting date reviewed 16 th April 2008 Designated NWORTH member

More information

Louise Brook Clinical Trials Quality Monitor. Date

Louise Brook Clinical Trials Quality Monitor. Date Details: Author: Louise Brook Clinical Trials Quality Monitor SOP Pages: 12 Version No. of replaced SOP: Effective date of replaced SOP: NA NA Approval: Version No: of the SOP being approved. Name of person

More information

Clinical trials from CRA s point of view

Clinical trials from CRA s point of view Clinical trials from CRA s point of view Dr Jacek S Gregorczyk MPharmS, PhD Clinical Research Associate (CRA) at MDS Pharma Services UK office - a global CRO REGULATION of CLINICAL TRIALS World Medical

More information

Good Clinical Practice Compliance

Good Clinical Practice Compliance Good Clinical Practice Compliance Pharmaceutical Regulatory & Compliance Congress Greg Levine LLP Agenda? GCP compliance rules What is the law? What other (non-binding) standards apply? What are the unwritten

More information

IRB-GCP and Timelines. Andrew Majewski, MSc. 1 st DOLF Meeting Washington University School of Medicine St Louis, Missouri-USA October th, 2010

IRB-GCP and Timelines. Andrew Majewski, MSc. 1 st DOLF Meeting Washington University School of Medicine St Louis, Missouri-USA October th, 2010 IRB-GCP and Timelines Andrew Majewski, MSc. 1 st DOLF Meeting Washington University School of Medicine St Louis, Missouri-USA October 11-14 th, 2010 1 Factors that affect Timelines Finalized Protocol Finalized

More information

3.1. Overall Principal Investigator (PI), who holds the IND and is the Sponsor.

3.1. Overall Principal Investigator (PI), who holds the IND and is the Sponsor. POLICY #: RCO-100 Page: 1 of 11 1. POLICY STATEMENT: An Overall Principal Investigator (PI) who holds an Investigational New Drug Application (IND) and who is the Sponsor of the research has additional

More information

NIS Considerations - Bulgaria

NIS Considerations - Bulgaria NIS Considerations - Bulgaria An overview of the considerations when conducting Noninterventional Studies in Bulgaria Stuart McCully CHCUK Ltd NIS-C-BG-2014 1 Table of Contents Disclaimer 5 Copyright 5

More information

Clinical Trials How, Why and When? Candidate to Market 16 th May 2012 Kirsty Kwiatkowski

Clinical Trials How, Why and When? Candidate to Market 16 th May 2012 Kirsty Kwiatkowski Clinical Trials How, Why and When? Candidate to Market 16 th May 2012 Kirsty Kwiatkowski Agenda Why are clinical trials conducted? History Guidelines and Regulations When are trials conducted? Requirements

More information

SPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT

SPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT SPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT DOCUMENT NO.: GS010 v1.0 AUTHOR: Vikki Young ISSUE DATE: 28 MAY 2018 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research &

More information

Good Clinical Practice

Good Clinical Practice Clinical Site Monitoring DMID/ICSSC 10/7/08 1 Monitoring ICH E6 5.18.1 The purpose of monitoring is to ensure that: The rights and well-being of subjects are being protected The data are accurate, complete

More information

Phase Appropriate GMPs for IMPs. Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017

Phase Appropriate GMPs for IMPs. Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017 Phase Appropriate GMPs for IMPs Presented by: Karen S. Ginsbury For: IFF, October 31, Nov 02, 2017 1 Lets start with References https://mhrainspectorate.blog.gov.uk/2016/0 5/20/manufacture-of-investigationalmedicinal-products-frequently-askedquestions/

More information

Quality Site Visit Report FGK Clinical Research (FGK) GmbH, Munich Germany. Audit No. CT6018. Date of Audit: 3rd to 5th May 2017

Quality Site Visit Report FGK Clinical Research (FGK) GmbH, Munich Germany. Audit No. CT6018. Date of Audit: 3rd to 5th May 2017 Quality Site Visit Report FGK Clinical Research (FGK) GmbH, Munich Germany Head Office Address FGK Clinical Research GmbH Heimeranstrasse 35, 80339 Munich, Germany Research Centre Address FGK Clinical

More information

Drug Accountability. Kevin E. Anger PharmD, BCPS Manager Investigational Drug Services Brigham and Women s Hospital

Drug Accountability. Kevin E. Anger PharmD, BCPS Manager Investigational Drug Services Brigham and Women s Hospital Drug Accountability Kevin E. Anger PharmD, BCPS Manager Investigational Drug Services Brigham and Women s Hospital Session Objectives Define drug accountability and drugs in need of these accountability

More information

Inspections: an academic perspective

Inspections: an academic perspective Inspections: an academic perspective Patricia Henley Quality and Governance Manager Head, Research Governance & Integrity Office London School of Hygiene & Tropical Medicine Email: patricia.henley@lshtm.ac.uk

More information

HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)

HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) GUIDANCE FOR IMPLEMENTATION HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) GUIDANCE FOR IMPLEMENTATION WHO Library Cataloguing-in-Publication Data

More information

Standard Operating Procedure. SOP effective: 21 December 2017 Review date: 21 December 2019

Standard Operating Procedure. SOP effective: 21 December 2017 Review date: 21 December 2019 Standard Operating Procedure SOP number: SOP full title: SOP-JRO-12-003 Archiving Clinical Research Documents SOP effective: 21 December 2017 Review date: 21 December 2019 SOP author signature: SIGNED

More information

Regulatory Document Guidelines for DMID Clinical Studies. Version Oct-2005

Regulatory Document Guidelines for DMID Clinical Studies. Version Oct-2005 Regulatory Document Guidelines for DMID Clinical Studies Version 3.0-5-Oct-2005 1 Regulatory File Document Guidelines Purpose: To aid DMID supported Investigators in establishing a file of essential documents

More information

Monitorización del ensayo clínico

Monitorización del ensayo clínico Monitorización del ensayo clínico Dr. Salvador Ribas Ribas E-mail: salvador.ribas@gmail.com III CURSO PARA INVESTIGADORES SOBRE NORMAS DE BUENA PRÁCTICA CLÍNICA (BPC) Tenerife, 16 de septiembre 2009 Definition

More information

Guidance on Requirements of the Sponsor and the Investigator as a Sponsor

Guidance on Requirements of the Sponsor and the Investigator as a Sponsor Guidance on Requirements of the Sponsor and the Investigator as a Sponsor University of Colorado Denver (UCD) secures assurances from the sponsor or the investigator-sponsor* that the manufacture and formulation

More information

Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials

Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials 1 2 3 4 5 6 7 1 February 2013 EMA/INS/GCP/636736/2012 Good Clinical Practice Inspectors Working Group (GCP IWG) Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic)

More information

Human Research Protection Program Good Clinical Practice Guidance for Investigators Regulatory File Essential Documents

Human Research Protection Program Good Clinical Practice Guidance for Investigators Regulatory File Essential Documents Guidance for s Regulatory File Essential s All principal investigators must maintain a regulatory binder or file system, which contains all study documentation. These records may be reviewed at the time

More information

Agenda. 16:00 16:10 Velkommen 16:10 16:15 Inspektion, hvad er det?

Agenda. 16:00 16:10 Velkommen 16:10 16:15 Inspektion, hvad er det? Agenda 16:00 16:10 Velkommen 16:10 16:15 Inspektion, hvad er det? 16:15 17:15 Electronic systems for handling of: Source data Data collection tools 17:15 17:45 Pause og networking 17:45 18:30 Trial Master

More information

MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155

MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155 MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155 EXECUTIVE SUMMARY Medical device regulations around the world generally require manufacturers of most types of medical devices to supply data as part

More information