1 Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010
2 Objective To describe the role that Health Canada plays in clinical research in Canada To provide an overview of the GCP compliance monitoring program in Canada To explain the process by which clinical trial inspections are conducted in Canada To provide a summary of findings from inspections conducted since 2002
4 Structure and Responsibilities Our Mandate: Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.
5 Structure and Responsibilities (cont d) Partial Structure: Health Canada (HPFB) Regions And Programs Branch (RAPB) Since April 1 st, 2010 HPFB Good Clinical Practices Compliance Unit Operational Centres Halifax, Nova Scotia Montreal, Quebec Toronto, Ontario Winnipeg, Manitoba Vancouver, British Columbia
6 Structure and Responsibilities (cont d) Overview of Clinical Trial Oversight CTA Approval Adverse Event Monitoring Clinical Trial Oversight Clinical Trial Inspections Operational Centres (RAPB) in collaboration with the (HPFB)
7 Structure and Responsibilities (cont d) Western Operational Centre, Vancouver, BC Alberta Operational Centre, Edmonton, AB Manitoba and Saskatchewan Operational Centre, Winnipeg, MB Compliance Quebec Operational Coordination and Centre, Montreal, QC Licensing Division, Ottawa, ON Ontario and Nunavut Operational Centre, Toronto, ON Atlantic Operational Centre, Halifax, NS
8 Structure and Responsibilities (cont d) The s primary role, in collaboration with the operational centres, is to deliver a national compliance and enforcement program for drugs, natural health products, medical devices, including biologics and genetic therapies. This includes a GCP program for the verification against and the enforcement of the regulatory framework for clinical trials involving human subjects.
9 Structure and Responsibilities (cont d) The s role is accomplished through 4 core functions: Inspection Compliance Verification/Investigation Establishment Licensing Laboratory Functions There is no establishment licensing requirement for clinical trials.
10 Structure and Responsibilities (cont d) The s guiding principles are: Transparency Compliance and Enforcement Policy Fairness Predictable and uniform national approach Based on Risk Management Decisions based on level of risk Commitment to Quality Qualified Staff Continuous Training
11 Clinical Trials Regulatory Framework Food and Drugs Act (FDA) Food and Drug Regulations (FDR), Division 5 Drugs for Clinical Trials Involving Human Subjects - Came into force on September 1, These regulations are not applicable to Medical Devices or Natural Health Products (NHPs) (other requirements apply) - Integrate Good Clinical Practices (GCP).
12 Overview of Division 5 of the FDR: C (Interpretation) C (Application) C (Prohibition) C (Application for Authorization) C (Authorization) C (Notification) C (Amendment) C (Additional Information and Samples)
13 C (Sponsor s Obligations GCP) Clinical trials regulatory framework is harmonized through the principles of good clinical practices, as described by ICH E6 Guideline for Good Clinical Practices. ICH E6 was adopted by Health Canada in ICH E6 outlines requirements for the design, conduct and recording of trials. Consistent with the Declaration of Helsinki.
14 C (Sponsor s Obligations GCP) It is the sponsor s responsibility to ensure adherence to good clinical practices, including those requirements outlined in this section. Few requirements are black and white The need for no more than one QI. ICH E6 provides interpretation. Some requirements differ from ICH E6 The duration of record retention (C ).
15 C (Sponsor s Obligations GCP) The clinical trial is scientifically sound and clearly described in a protocol; The clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division; Refer to ICH GCP sections 4.5 and Deviations from or changes to the protocol should not be done without Sponsor agreement and REB/Health Canada approval, as needed. Any deviation from the approved protocol should be documented and explained.
16 C (Sponsor s Obligations GCP) Systems and procedures that assure the quality of every aspect of the clinical trial are implemented; Refer to ICH GCP sections 5.1, 5.18 and QA and QC requirements, including:» Written SOPs to ensure compliance with the protocol, GCP, and regulatory requirements;» At a minimum, SOPs should cover informed consent process, AE reporting, handling of the drug, record retention;» Written agreements, made by the sponsor with any party(ies) involved with the clinical trial.
17 C (Sponsor s Obligations GCP) For each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site; Refer to definition of REB under C Refer to ICH GCP sections 4.4 and At each clinical trial site, there is no more than one QI; Refer to definition of QI under C
18 C (Sponsor s Obligations GCP) At each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the QI; Refer to ICH GCP sections 2.7 and 4.3. Provide adequate medical care to a subject for any AEs, including clinically significant laboratory values. Inform a subject when medical care is needed for intercurrent illness(es). Make a reasonable effort to ascertain the reason(s) for withdrawal, while fully respecting the subject's rights.
19 C (Sponsor s Obligations GCP) Each individual involved in the conduct of the clinical trial is qualified by education, training and experience; Refer to ICH GCP sections 2.8, , 4.2.4, and (b). There must be evidence of such qualifications. Includes knowledge by all trial personnel of:» the protocol, the investigational product(s) and their trialrelated duties and functions;» GCP and the applicable regulatory requirements. Includes supervision of the overall conduct of the trial, handling and verifying the data, conducting the statistical analyses, preparing the trial reports and monitoring the trial.
20 C (Sponsor s Obligations GCP) Written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of:» the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and» all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial Refer to ICH GCP sections 2.9 and 4.8.
21 C (Sponsor s Obligations GCP) The ICF must be approved, as well as any amendments; It is to be revised whenever important new information becomes available that may be relevant to the subject's consent; The subject should be informed in a timely manner if new information becomes available that may be relevant to his/her willingness to continue (to be documented); The subject should be fully informed of all pertinent aspects of the trial;
22 C (Sponsor s Obligations GCP) The language used should be as non-technical as practical and should be understandable to the subject; Time must be afforded to the subject to inquire about the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject; Prior to a subject's participation, the ICF should be signed and personally dated by the subject and by the person who conducted the informed consent discussion.
23 C (Sponsor s Obligations GCP) The subject must understand (via both the informed consent discussion and the ICF): That the trial involves research The purpose of the trial The trial treatment(s) and the probability for random assignment to each treatment The trial procedures to be followed The subject's responsibilities The alternatives that may be available to the subject, and their important potential benefits and risks
24 C (Sponsor s Obligations GCP) That their participation in the trial is voluntary and that they may refuse to participate or withdraw from the trial, at any time Who may be granted direct access to their original medical records for verification of clinical trial procedures and/or data That records identifying them will be kept confidential Whom to contact for further information The expected duration of their participation in the trial.
25 C (Sponsor s Obligations GCP) The requirements respecting information and records set out in section C are met; Refer to Guide-0068» Essential documents should be retained as per ICH E6 (REB: section 3.4, QI: section and Sponsor: section ).» The original records need to be kept for 25 years. The drug is manufactured, handled and stored in accordance with the applicable GMPs; Refer to Annex 2 to the Current Edition of the GMP Guidelines.
26 C (Labelling) The sponsor shall ensure that the drug bears a label that sets out the following information in both official languages: a statement indicating that the drug is an investigational drug to be used only by a qualified investigator the name, number or identifying mark of the drug the expiration date of the drug.
27 C (Labelling) the recommended storage conditions for the drug the lot number of the drug the name and address of the sponsor the protocol code or identification, and if the drug is a radiopharmaceutical as defined in section C , the information required by subparagraph C (1)(b)(vi).
28 C (Records) C (Submission of Information and Samples) C (Serious Unexpected Adverse Drug Reactions) C (Discontinuance of a Clinical Trial) C & C (Suspension & Cancellation)
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials
Health Products and Food Branch 1 HEALTH CANADA PART C DIVISION 5 - DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS Part C - Division 5 2 Part A: Part B: Part C: Part D: Part E: Part G: Part J: Administration
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program Part 2 GCP Information Sessions November 2010 Inspection Program Main objectives
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada: Clinical Trial Inspection Planning GCP Information Sessions November 2010 Overview GCP Inspection Target
Tip Sheet 11: Following the Guideline of the International Conference on Harmonization Good Clinical Practice (E6) Related Accreditation Elements: I.1.D., I.1.F., I-2, I.7.B., II.2.E., II.2.F., II.4.A.,
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
1.2 - Overview of Regulation of Clinical Trials in Canada Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office
L1 2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager,
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
Site Licensing & Good Manufacturing Practices Requirements for Natural Health Products in Canada Canadian Association of Professional Regulatory Affairs Annual Education Day - June 5, 2012 Raymond W. Tsang,
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
Investigator Responsibilities Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 010 Version number: 1 Effective date: 01 June 2010 Review due: May 2011
This Guidance Document is to ensure that investigators and research personnel recognize their responsibilities associated with the conduct of human subject research by outlining their responsibilities,
Principal Investigator and Sub Investigator Responsibilities I. Purpose To define the roles and responsibilities of Principal Investigators conducting research at GRU. II. Definition The term Principal
703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a
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,
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
Clinical Trials and Safety Surveillance of Drugs in Development Hoda Eid, M.Sc., Ph.D. Manager, ADR Unit Office of Clinical Trials Therapeutic Products Directorate email@example.com Overview Clinical
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Good Clinical Practices Its origins GCP Information Sessions November 2010 Objective To briefly describe the evolution
Essential Documents for the Conduct of a Clinical Trial Debra Dykhuis Associate Director RSO Introduction Rationale for choosing this topic AHC movement toward setting GCP (Good Clinical Practice) guidelines
Health Santé Your health and safety... our priority Votre santé et votre securité notre priorité Greetings Health is pleased to provide you with our new pre-inspection package to assist your organization
Regulator s Role in GCP David A. Lepay, M.D., Ph.D. APEC GCP Inspection Workshop May 27, 2008 Objectives of this Talk Review the roles and responsibilities of the regulatory authority under GCP Identify
GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group firstname.lastname@example.org Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,
A Clinical Research Coordinator for an International Study THE GYMNAST Anita Ng Research Coordinator The Scarborough Hospital May 12, 2007. 1. What is Research? 2. Characteristics of a Clinical Research
Quality Management in Clinical Research Julie Doherty MSN, RN Director, Regulatory Compliance Office of Academic Affairs Human Research Protections Office University of Maryland Baltimore March 17, 2016
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
Clinical Research Professional Certification & Preparing for the CCRP Exam Signe Denmark, MS, CCRP Toni Mauney, CCRP SoCRA: Society of Clinical Research Associates SoCRA established the Certification Program
Study Start-Up SS-204.01 STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell,
CLINICAL RESEARCH PROTOCOL CHECKLIST [taken from ICH GCP : Guidance for Industry, Good Clinical Practice: Consolidated Guidance, Revision 1 (R1) June 1996] ICH GCP, Section 6. CLINICAL TRIAL PROTOCOL AND
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
UK Implementation of the EU Clinical Trial Directive 2001/20/EC: GCP Aspects. Dr. Colin Wilsher, FRQA. BARQA GCP Committee Chairman; & Pfizer Worldwide Development Quality Assurance. GIQAR, Roma, October
The 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
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
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
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
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:
Differential Training by Job Function ACRP Job Analysis Results Morgean Hirt, ACA, Director of Certification Association of Clinical Research Professionals Disclaimer The views and opinions expressed in
2 Investment Dealers Association of Canada Dual Registration of Life Insurance Agents and Securities Salespersons The respective securities and insurance legislation and governing bodies of each of the
Marihuana for Medical Purposes Regulations October 16, 2014 Overview Provide an overview of the evolution of marihuana for medical purposes regulations in Canada Status of the old program/ Allard Injunction
SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: email@example.com Education: Masters of Science, Healthcare Administration, Capital City University,
Access to Basic Banking Services Opening a personal deposit account and cashing Government of Canada cheques or other instruments In order to improve access to basic banking services, legislation requires
TABLE OF CONTENTS Acknowledgments... xi Introduction... xiii 1 The Clinical Research Coordinator (CRC)... 1 Background and Training of the CRC...1 Personality and Skills... 2 Where Do CRCs Work?... 2 CRC
ICRIN Seminar on EU Regulation of Clinical Trials 12 th March 2013, Dublin J. Michael Morris Director Scientific Affairs IRISH MEDICINES BOARD 28/03/2013 Slide 1 Overview Clinical Trial (CT) legislation
NATIONAL STUDY OF AUTOMOBILE INSURANCE RATES Third Release Atlantic Provinces 71 COMMUNITIES vs. British Columbia, Alberta Saskatchewan, Manitoba & Ontario 3,985,162 Auto Insurance Rates Compared October
Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute PURPOSE Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page
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
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) U.S. Department of Health and Human Services Food and Drug
CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL #  [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities
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
To Certify or Not to Certify Sandra Halvorson, BA, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus Sue Logan, BS, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus November
To Certify or Not to Certify Sandra Halvorson, BA, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus Sue Logan, BS, CCRP Clinical Research Coordinator II We have no financial relationships
REGULATION (EEC) No 2309/93 Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use
College of Physicians and Surgeons of British Columbia Professional Standards and Guidelines Conflict of Interest Arising from Clinical Research Preamble This document is a guideline of the Board of the
STANDARD OPERATING PROCEDURE Site Initiation and Closeout Standard Operating Procedure Western Health SOP reference 008 Version: 2.0 dated December 2015 Effective Date Review Date Author: Approved by Mr
IRB POLICY ON HUMAN RESEARCH PROTECTION (HRP) AND GOOD CLINICAL PRACTICE (GCP) TRAINING Collaborative Institutional Training Initiative (CITI) Requirements at Adventist Healthcare, Inc. I. Required Human
Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions U.S. Department of Health and Human Services Food and Drug Administration
A Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky I. Compliance with IRB and Applicable Federal Requirements A. Investigators
The College of Licensed Practical Nurses of Nova Scotia (the College) is the regulatory body for Licensed Practical Nurses (LPNs) in Nova Scotia. The Colleges mandate is to protect the public by promoting
CHANGE SUMMARY: This policy and associated appendices have been reviewed for accuracy and updated to meet 508 compliance guidelines. Key changes to the policy require all sites to submit a bi-annual Clinical
Public Policy Statement: Clinical Trial Ethics Purpose As a global healthcare company, Merck's role is first and foremost to discover, develop and provide innovative products and services that save and
Standards for Nursing Education in New Brunswick February 2013 (1/ 13) Mission The Nurses Association of New Brunswick is a professional regulatory organization that exists to protect the public and to
Professional Standards For Dietitians In Canada Developed by: Dietitians of Canada College of Dietitians of Ontario in collaboration and with financial support from: British Columbia Dietitians' and Nutritionists'
Document Template #1 Adult/General Informed Consent (Rev. 9/20/2011) Consent Form for Participation in the Research Study Entitled XYZ (or can be written in the XYZ study ) Funding Source: List complete
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit ICH Topic E 6 Guideline for Good Clinical Practice Step 5, Consolidated Guideline 1.5.96 NOTE FOR GUIDANCE ON
Rules Notice Technical Dealer Member Rules Please distribute internally to: Legal and Compliance Registration Contact: Wendyanne D Silva Director, Registrations 416-865-3032 firstname.lastname@example.org 10-0062 March
Pharmacy Technician Structured Practical Training Program MANUAL AND SUBMISSION FORMS December 2014 (Updated July 2015) *To be reviewed by Supervisor and Pharmacy Technician-in-Training and used in conjunction
The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial Clinical Research Operations & Regulatory Support (CRORS) Ann Glasse, RN, BSN, MBA Director-CRORS Objectives
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
The Clinical Trial Protocol Guide 2011 BioStrategics Consulting Ltd. BioStrategics Consulting Ltd THE CLINICAL TRIAL PROTOCOL The clinical trial protocol to test one s product, to confirm or reject a specific
Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation Presentation to the American Association of Tissue Banks Savannah, Georgia March 2008 Health Canada Update Marianne
Registered Nurse (Nurse Practitioner) Controlled Drugs and Substances Practice Guidelines In November 2012, the New Classes of Practitioners Regulations (NCPR) under Canada s Controlled Drug and Substances
Guide to Child Labour Laws in Canada Parents and employers must ensure that the safety and health at work of employed youths are protected. Where children are employed, employers must make special efforts
1 2 3 23 July 2015 EMA/CHMP/ICH/135/1995 Committee for Human Medicinal Products 4 5 Step 2b Adopted by CHMP for release for consultation 23 July 2015 Start of public consultation 4 August 2015 End of consultation
Your New Banking Rights What you should know about access to basic banking services Table of Contents Protecting Consumers: The New Federal Banking Regulations...2 Opening a Personal Bank Account...3 When
APPROVAL PROCESS FOR NURSE PRACTITIONER EDUCATION PROGRAMS 2015 This Regulatory Document was approved by ARNNL Council in 2015. Approval Process for Nurse Practitioner Education Programs Table of Contents
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
Managing Risk in Clinical Research Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Aim of the session To explore the risks associated with clinical research and understand how
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6 Recommended
Site Initiation and Close Out (Sponsored Clinical Trials) Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 008 Version number: 1 Effective date: 01 June