Health Products and Food Branch.

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Health Products and Food Branch. www.hc-sc.gc.ca"

Transcription

1 Health Products and Food Branch 1 HEALTH CANADA PART C DIVISION 5 - DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS

2 Part C - Division 5 2 Part A: Part B: Part C: Part D: Part E: Part G: Part J: Administration Foods Drugs Vitamins, Minerals and Amino Acids Cyclamate and Saccharin Sweeteners Controlled Drugs Restricted Drugs

3 Part C: Drugs Part C Division 5 Division 1 Drugs General/Establishment Licenses Division 2 Good Manufacturing Practices Division 3 Schedule C drugs (Radiopharmaceuticals) Division 4 Schedule D drugs (Biological) Division 5 Drugs for Clinical Trials Involving Human Subjects Division 6 Canadian Standard Drugs Division 7 Sale of drugs for the purposes of implementing the general council decision Division 8 - New Drugs Division 9 Prescription Drugs 3

4 Clinical Trials Regulatory Framework Food and Drugs Act (FDA) 4 Food and Drug Regulations (FDR), Division 5 Came into force on September 1, 2001 Regulations are not applicable to Medical Devices or Natural Health Products Integrate Good Clinical Practices

5 Regulatory Framework 5 Food and Drugs Act Food and Drugs Regulations Part C: Drugs Other Regulations Division 5: Drugs for Clinical Trials involving Human Subjects

6 Key Aspects of Division 5 Introduction of a 30-day review default period for clinical trial applications Requirement for REB approvals prior to enrolment Integration of Good Clinical Practices (GCP) Requirements for clinical trial sites, Qualified Investigators (QI), REBs and Sponsors Requirement for adverse reaction reporting 6

7 Overview of Division 5 (C ) Interpretation Qualified Investigator: 7 The person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where the laws of the province where that clinical trial site is located In the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association In any other case, a physician and a member in good standing of a professional medical association

8 Overview of Division 5 8 (C ) Interpretation cont d Research Ethics Board A body that is not affiliated with the sponsor, and The principal mandate of which is to approve the initiation of and conduct periodic reviews of, biomedical research involving human subjects That has at least five members, that has a majority of members who are Canadian citizens or permanent residents and that includes at least Two member whose primary experience and expertise are in a scientific discipline One member knowledgeable in ethics One member knowledgeable in Canadian laws One member whose primary experience and expertise are in a nonscientific discipline One member who is from the community

9 (C ) Application Overview of Division 5 This Division applies to the sale or importation of drugs to be used for the purposes of clinical trials involving human subjects 9 (C ) Prohibition No person shall sell or import a drug for the purposes of a clinical trial unless The person is authorized under this Division; The person complies with this Division If the drug is to be imported, the person has a representative in Canada who is responsible for the sale of the drug.

10 (C ) General Overview of Division 5 10 Despite these Regulations, a sponsor may submit an application under this Division to sell or import a drug for the purposes of a clinical trial that contains a substance the sale of which is prohibited by these Regulations, if the sponsor establishes, on the basis of scientific information, that the inclusion of the substance in the drug may result in the therapeutic benefit for a human being

11 Overview of Division 5 (C ) Application for Authorization 11 An application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial under this Division shall be submitted to the Minister, signed and dated by the sponsor s senior medical or scientific officer in Canada and senior executive officer

12 (C ) Authorization Overview of Division 5 12 A sponsor may sell or import a drug for the purposes of a clinical trial if: The sponsor has submitted an application Health Canada has not objected to the conduct of the study (30 days default period) For each clinical trial site REB approval has been obtained Information is submitted about the QI, the REB that granted approval and any that refused to approve the study, as well as the proposed date for the commencement of the trial

13 (C ) Notification Overview of Division 5 The sponsor may make the following changes: 13 A change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C and A change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C The sponsor must notify Health Canada within 15 days after the date of the change

14 (C ) Amendment Overview of Division 5 14 The sponsor may sell or import the drug for the purposes of the clinical trial in accordance with the amended authorization if: The sponsor has submitted an application for amendment Health Canada has not objected (30 day default period) Each clinical trial site: Information is submitted about the REB that granted approval for the amendment and any that refused to approve the amended study Any changes to the commencement date and/or the QI information are documented The sponsor ceases to sell or import the drug in accordance with the existing authorization

15 Overview of Division 5 15 (C ) Additional Information and Samples The sponsor may be required to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination (C ) Sponsors Obligations GCP Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices including: 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

16 Overview of Division 5 (C ) Sponsor s Obligations cont d Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices including: Systems and procedures that assure the quality of every aspect of the clinical trial are implemented For each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site At each clinical trial site, there is no more than one QI At each clinical trial site, medical care and medical decisions in respect of the clinical trial are under the supervision of the QI Each individual involved in the conduct of the trial is qualified by education, training and experience 16

17 Overview of Division 5 (C ) Sponsor s Obligations cont d Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices including: Written informed 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 All other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial The requirements respecting information and records set out in section C are met The drug is manufactured, handled and stored in accordance with Good Manufacturing Practices (GMP 17

18 (C ) Labelling Overview of Division 5 Ensure that drug bears a label in both official languages detailing 18 Lot number; storage conditions; sponsor name and address, expiration date; protocol id and statement that it is an investigational product only to be used by a qualified investigator

19 (C ) Records Overview of Division 5 19 The sponsor shall record, handle and store all information that allows and supports the complete and accurate reporting, interpretation and verification of clinical trial data and that establishes that the clinical trial was conducted in accordance with GCP and these regulations The sponsor shall maintain complete and accurate records in respect of the use of a drug in a clinical trial including: All versions of the Investigator Brochure including rationale and documentation that supports each change Drug shipment, receipt, disposition, return and destruction records Enrolled subject information sufficient to identify all trial subjects in the event that they need to be contacted due to safety concerns Adverse event records including dosage and indication information at the time of the event

20 Overview of Division 5 20 (C ) Records cont d Records respecting the enrollment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the clinical trial subjects or other persons Records respecting the shipment, receipt, disposition, return and destruction of the drug

21 Overview of Division 5 (C ) Records cont d 21 For each clinical trial site, an undertaking from the QI that is signed and dated by the QI prior to the commencement of responsibilities in respect of the clinical trial stating that QI will conduct the trial in accordance with GCP QI will immediately notify clinical trial subjects and research ethics board of discontinuance of the trial by the sponsor and advise them in writing of any potential risks REB signed and dated attestation (each site) stating Reviewed and approved the protocol and informed consent Board carries out its functions consistent with GCP

22 Overview of Division 5 (C ) Records cont d 22 For each clinical trial site, an attestation, signed and dated by the REB for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices The sponsor shall maintain all records referred to in this division for 25 years

23 Overview of Division 5 (C ) Submission of Information and Samples 23 The sponsor may be required to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial or samples of the drug, if the Minister has reasonable grounds to believe that: The use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person The clinical trial is contrary to the best interests of a trial subject The objectives of the trial will not be achieved A QI is not respecting the undertaking False or misleading information is submitted The sponsor may be required to submit, within 7 days after receipt of the request, information, records or samples of the drug in order to assess the safety of the drug or the trial subjects

24 Overview of Division 5 (C ) Serious Unexpected Adverse Drug Reaction Reporting The Sponsor will inform the Minister of any SUADR that have occurred inside or outside of Canada Fatal or life threatening within 7 days of becoming aware of the information 24 Not Fatal or life threatening within 15 days of becoming aware of the information Submit to the Minister a complete report including implication of findings

25 Overview of Division 5 (C ) Discontinuation of a Clinical Trial If a clinical trial is discontinued, the sponsor shall: Inform Health Canada no later than 15 days after the date of the discontinuance 25 Provide the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the drug conducted in Canada by the sponsor Inform all QIs of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the In respect of each discontinued clinical trial site, stop the sale or importation of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold

26 Overview of Division 5 (C & C ) Suspension and Cancellation 26 The authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, may be suspend if: The sponsor has contravened these Regulations or any provision of the Act relating to the drug Any information submitted in respect of the drug or clinical trial is false or misleading The sponsor has failed to comply with GCP The sponsor will be given an opportunity to be heard, unless there are reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a trial subject or other person

27 Summary 27 Clinical trials regulated under a legal framework Incorporating GCPs CTA required for Phase I, II, III 30 calendar day review period with 2 day turnaround for requests for additional information Ongoing requirements after authorization

Health Canada s GCP Compliance Program. GCP Information Sessions November 2010

Health Canada s GCP Compliance Program. GCP Information Sessions November 2010 Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010 Objective To describe the role that Health

More information

2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials

2.2 Roles and Responsibilities in the Conduct and Assessment of Clinical Trials 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,

More information

1.2 - Overview of Regulation of Clinical Trials in Canada

1.2 - Overview of Regulation of Clinical Trials in Canada 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

More information

Clinical Trials and Safety Surveillance of Drugs in Development

Clinical Trials and Safety Surveillance of Drugs in Development 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 hoda_eid@hc-sc.gc.ca Overview Clinical

More information

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE

GOOD 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 information

Tip Sheet 11: Following the Guideline of the International Conference on Harmonization Good Clinical Practice (E6)

Tip Sheet 11: Following the Guideline of the International Conference on Harmonization Good Clinical Practice (E6) 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.,

More information

Health Canada s GCP Compliance Program Part 2. GCP Information Sessions November 2010

Health Canada s GCP Compliance Program Part 2. GCP Information Sessions November 2010 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

More information

New Investigator Collaborations and Interactions: Regulatory

New Investigator Collaborations and Interactions: Regulatory Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials

More information

Medical 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

Medical 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 information

Investigational Drugs: Investigational Drugs and Biologics

Investigational Drugs: Investigational Drugs and Biologics : I. PURPOSE The purpose of this policy is to establish procedures for the proper control, storage, use and handling of investigational drugs and biologics to ensure that adequate safeguards are in place

More information

12.0 Investigator Responsibilities

12.0 Investigator Responsibilities v. 5.13.13 12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement,

More information

Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation

Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation 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

More information

ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014

ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014 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 information

DESCRIPTION OF THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004

DESCRIPTION OF THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004 DESCRIPTION OF THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004 Page 1 of 17 TABLE OF CONTENTS INTRODUCTION 4 EXECUTIVE SUMMARY 4 PUBLIC HEALTH BENEFITS 5 Good clinical practice 5 Good manufacturing

More information

Health Canada: Clinical Trial Inspection Planning. GCP Information Sessions November 2010

Health Canada: Clinical Trial Inspection Planning. GCP Information Sessions November 2010 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

More information

AUSTRALIAN MEDICAL DEVICES GUIDELINES

AUSTRALIAN MEDICAL DEVICES GUIDELINES AUSTRALIAN MEDICAL DEVICES GUIDELINES Obligations and Responsibilities of Medical Device Sponsors and Manufacturers Guidance Document Number 20 Version 1.6 DISCLAIMER This document is provided for guidance

More information

Essential Documents for the Conduct of a Clinical Trial. Debra Dykhuis Associate Director RSO

Essential Documents for the Conduct of a Clinical Trial. Debra Dykhuis Associate Director RSO 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

More information

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE 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 information

University of Oklahoma Office of Human Research Participant Protection SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES

University of Oklahoma Office of Human Research Participant Protection SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES 1. POLICY SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES The purpose of this policy is to outline the qualifications and responsibilities of the principal investigator and key personnel who

More information

RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING

RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Introduction 2 2. Scope 2 3. Documents to be archived 2 4. Quality of essential documents 10 5.

More information

Ontario Public Drug Programs / Cancer Care Ontario Policy: Reimbursement of Publicly Funded Cancer Drugs within the Context of Clinical Trials

Ontario Public Drug Programs / Cancer Care Ontario Policy: Reimbursement of Publicly Funded Cancer Drugs within the Context of Clinical Trials Ontario Public Drug Programs / Cancer Care Ontario Policy: Reimbursement of Publicly Funded Cancer Drugs within the Context of Clinical Trials Version: 2.0 Effective Date: January 29, 2016 Replaces Policy:

More information

Investigator Responsibilities

Investigator Responsibilities 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

More information

ICRIN Seminar on EU Regulation of Clinical Trials

ICRIN Seminar on EU Regulation of Clinical Trials ICRIN Seminar on EU Regulation of Clinical Trials 12 th March 2013, Dublin J. Michael Morris Director Scientific Affairs IRISH MEDICINES BOARD 28/03/2013 Slide 1 Overview Clinical Trial (CT) legislation

More information

CLINICAL RESEARCH PROTOCOL CHECKLIST

CLINICAL RESEARCH PROTOCOL CHECKLIST 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

More information

Vertex Investigator-Initiated Studies Program Overview

Vertex Investigator-Initiated Studies Program Overview Vertex Investigator-Initiated Studies Program Overview Our Goal To support independent, investigator-initiated research designed to advance scientific knowledge of disease states, patient populations,

More information

Roles & Responsibilities of the Sponsor

Roles & Responsibilities of the Sponsor Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from

More information

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities 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,

More information

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

Introduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6 Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication

More information

and Regulatory Aspects

and Regulatory Aspects Good Clinical Practice and Regulatory Aspects Nora Espiritu MD, MPh, PhD (c) Former Executive Director of Research and Technology Transfer. Peruvian National Institute t of Health. Member of the Ethics

More information

The Study Site Master File and Essential Documents

The 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 information

CLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES

CLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES 1. Clinical Study Team Principal Investigator Co Principal Investigator (Co PI) Research Coordinator Study Monitor Data manage Sponsor Post Doctoral Scholar

More information

THE CLINICAL TRIALS BILL (No. XIX of 2010) Explanatory Memorandum

THE 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 information

Principal Investigator and Sub Investigator Responsibilities

Principal Investigator and Sub Investigator 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

More information

ONTARIO REGULATION proposed to be made under the

ONTARIO REGULATION proposed to be made under the Caution: This draft regulation is provided solely to facilitate dialogue concerning its contents. Should the decision be made to proceed with the proposal, the comments received during consultation will

More information

REGULATION (EEC) No 2309/93

REGULATION (EEC) No 2309/93 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

More information

Standards of Practice for Pharmacists and Pharmacy Technicians

Standards of Practice for Pharmacists and Pharmacy Technicians Standards of Practice for Pharmacists and Pharmacy Technicians Introduction These standards are made under the authority of Section 133 of the Health Professions Act. They are one component of the law

More information

Alberta Regulation 37/2002. Child Welfare Act ADOPTION REGULATION. Table of Contents. Part 1 Licensed Adoption Agencies

Alberta Regulation 37/2002. Child Welfare Act ADOPTION REGULATION. Table of Contents. Part 1 Licensed Adoption Agencies Alberta Regulation 37/2002 Child Welfare Act ADOPTION REGULATION Filed: March 20, 2002 Made by the Minister of Children s Services (M.O. 42/02) on March 14, 2002 pursuant to section 131(2) of the Child

More information

Marihuana for Medical Purposes Regulations. October 16, 2014

Marihuana for Medical Purposes Regulations. October 16, 2014 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

More information

FDA Audit Guidelines. University of Miami. Office of the Vice Provost for Research

FDA Audit Guidelines. University of Miami. Office of the Vice Provost for Research FDA Audit Guidelines University of Miami Office of the Vice Provost for Research FDA Audit Guidelines Contents INTRODUCTION 3 VICE PROVOST FOR RESEARCH ROLE IN FDA AUDITS 3 PRE-AUDIT REVIEW 3 INSPECTION

More information

Site Initiation and Close Out (Sponsored Clinical Trials)

Site Initiation and Close Out (Sponsored Clinical Trials) 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

More information

LEBANESE MINISTRY OF HEALTH DIRECTIVE

LEBANESE MINISTRY OF HEALTH DIRECTIVE LEBANESE MINISTRY OF HEALTH DIRECTIVE LAYING DOWN DETAILED GUIDELINES FOR SPONSORS OF CLINICAL TRIALS March 2012 Field of Application General Considerations Trial s submission Validity of the F-MRI opinion

More information

Reliance Agreement for Institutions Utilizing Stony Brook University s Institutional Review Board(s)

Reliance Agreement for Institutions Utilizing Stony Brook University s Institutional Review Board(s) Name of Organization Providing IRB Review: Stony Brook University ( SBU IRB ) Name of Institution Relying on the SBU IRB ( Institution ): Latest AAHRPP Accreditation Date (if applicable) OHRP Federal Wide

More information

TASMC INSTITUTIONAL REVIEW BOARD

TASMC INSTITUTIONAL REVIEW BOARD (Translation from Hebrew) Page 1 of 19 1 DEFINITIONS 1.1 The institutional committee supervising medical studies and experiments involving human subjects at the Tel-Aviv Sourasky Medical Center (TASMC)

More information

Appendix 1. This appendix is a proposed new module of the DFSA Rulebook. Therefore, the text is not underlined as it is all new text.

Appendix 1. This appendix is a proposed new module of the DFSA Rulebook. Therefore, the text is not underlined as it is all new text. Appendix 1 This appendix is a proposed new module of the DFSA Rulebook. Therefore, the text is not underlined as it is all new text. The DFSA Rulebook Auditor Module (AUD) PART 1 INTRODUCTION 1 APPLICATION

More information

Greetings. www.hc-sc.gc.ca/gcp

Greetings. www.hc-sc.gc.ca/gcp 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

More information

Study Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV)

Study Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) 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,

More information

Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination

Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination 5.1. Recordkeeping Policy In accordance with federal regulations (45 CFR 46.115 and

More information

CONDUCTING GLOBAL CLINICAL RESEARCH TRIALS:

CONDUCTING GLOBAL CLINICAL RESEARCH TRIALS: CONDUCTING GLOBAL CLINICAL RESEARCH TRIALS: COMPARING AND CONTRASTING FDA MEDICAL DEVICE REGULATIONS FOR CLINICAL INVESTIGATORS WITH ISO 14155:2011 Introduction Today s clinical research landscape for

More information

Guide for Research Sites Seeking Accreditation

Guide for Research Sites Seeking Accreditation Guide for Research Sites Seeking Accreditation (For research sites that only conduct research and do not have their own IRBs) November 16, 2010 Purpose of the Guide The accreditation process for most research

More information

Adventist HealthCare, Inc.

Adventist HealthCare, Inc. IRB POLICY ON HUMAN RESEARCH PROTECTION (HRP) AND GOOD CLINICAL PRACTICE (GCP) TRAINING Collaborative Institutional Training Initiative (CITI) Requirements at Adventist Healthcare, Inc. I. Required Human

More information

9.0 Protocol Violations, Deviations, and Exceptions. 9.1 Definitions

9.0 Protocol Violations, Deviations, and Exceptions. 9.1 Definitions 9.0 Protocol Violations, Deviations, and Exceptions 9.1 Definitions Protocol deviation(s): means a minor or administrative departure from the IRBapproved protocol procedures (e.g., the protocol, informed

More information

Understanding Alberta s Drug Schedules

Understanding Alberta s Drug Schedules Understanding Alberta s Drug Schedules Preface In May 2002, the provincial drug schedules to the Pharmaceutical Profession Act were amended. In April 2007, the Alberta Regulation 66/2007 to the Pharmacy

More information

The Credit Reporting Act

The Credit Reporting Act 1 CREDIT REPORTING c. C-43.2 The Credit Reporting Act being Chapter C-43.2 of The Statutes of Saskatchewan, 2004 (effective March 1, 2005). NOTE: This consolidation is not official. Amendments have been

More information

Yale University Open Data Access (YODA) Project Procedures to Guide External Investigator Access to Clinical Trial Data Last Updated August 2015

Yale University Open Data Access (YODA) Project Procedures to Guide External Investigator Access to Clinical Trial Data Last Updated August 2015 OVERVIEW Yale University Open Data Access (YODA) Project These procedures support the YODA Project Data Release Policy and more fully describe the process by which clinical trial data held by a third party,

More information

Act of 26 February 1998, containing rules on medical research involving human subjects (Medical Research (Human Subjects) Act)

Act 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 information

IMP management at site. Dmitry Semenyuta

IMP management at site. Dmitry Semenyuta IMP management at site Dmitry Semenyuta TOP 5 FDA inspections finding 1999-2009 Center of Drug Evaluation and Research (CDER) Failure to follow the protocol Failure to keep adequate and accurate records

More information

Guidance for IRBs, Clinical Investigators, and Sponsors. Considerations When Transferring Clinical Investigation Oversight to Another IRB

Guidance for IRBs, Clinical Investigators, and Sponsors. Considerations When Transferring Clinical Investigation Oversight to Another IRB Guidance for IRBs, Clinical Investigators, and Sponsors Considerations When Transferring Clinical Investigation Oversight to Another IRB U.S. Department of Health and Human Services Food and Drug Administration

More information

PLEASE NOTE. For more information concerning the history of these regulations, please see the Table of Regulations.

PLEASE NOTE. For more information concerning the history of these regulations, please see the Table of Regulations. PLEASE NOTE This document, prepared by the Legislative Counsel Office, is an office consolidation of this regulation, current to February 25, 2006. It is intended for information and reference purposes

More information

CHAPTER 61-03-02 CONSULTING PHARMACIST REGULATIONS FOR LONG-TERM CARE FACILITIES (SKILLED, INTERMEDIATE, AND BASIC CARE)

CHAPTER 61-03-02 CONSULTING PHARMACIST REGULATIONS FOR LONG-TERM CARE FACILITIES (SKILLED, INTERMEDIATE, AND BASIC CARE) CHAPTER 61-03-02 CONSULTING PHARMACIST REGULATIONS FOR LONG-TERM CARE FACILITIES (SKILLED, INTERMEDIATE, AND BASIC CARE) Section 61-03-02-01 Definitions 61-03-02-02 Absence of Provider or Consulting Pharmacist

More information

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs 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

More information

PROCEDURES FOR BUS DRIVER DRUG AND ALCOHOL TESTING

PROCEDURES FOR BUS DRIVER DRUG AND ALCOHOL TESTING PROCEDURES FOR BUS DRIVER DRUG AND ALCOHOL TESTING District bus drivers are subject to a drug and alcohol testing program that fulfills the requirements of the federal regulations. The School District

More information

Policies & Procedures

Policies & Procedures 2.2 Drug Free Work Place Adopted 1.24.2003 Revised 3.28.2004; 5.26.2006; 3.2.2011 Reference: WAC 388.805.200(3) POLICY In accordance with "The Drug Free Workplace Act of 1988, The Healing Lodge prohibits

More information

IRB Submissions and Human Subjects Research Compliance. Georgia Health Sciences University

IRB Submissions and Human Subjects Research Compliance. Georgia Health Sciences University IRB Submissions and Human Subjects Research Compliance Offi f H R hp t ti Office of Human Research Protection Georgia Health Sciences University Objectives Identify the steps required to submit a protocol

More information

Guidance for Industry Direct-to-Consumer Television Advertisements FDAAA DTC Television Ad Pre- Dissemination Review Program

Guidance for Industry Direct-to-Consumer Television Advertisements FDAAA DTC Television Ad Pre- Dissemination Review Program Guidance for Industry Direct-to-Consumer Television Advertisements FDAAA DTC Television Ad Pre- Dissemination Review Program DRAFT GUIDANCE This guidance document is being distributed for comment purposes

More information

An Act to amend the Act respecting immigration to Québec

An Act to amend the Act respecting immigration to Québec FIRST SESSION THIRTY-SEVENTH LEGISLATURE Bill 53 (2004, chapter 18) An Act to amend the Act respecting immigration to Québec Introduced 13 May 2004 Passage in principle 2 June 2004 Passage 17 June 2004

More information

Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs

Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs Role of the Investigational Drug Services (IDS) in the Management of Investigational Drugs Charlesworth Rae, BS, PharmD, JD Investigational Drug Pharmacist July 2012 1 Outline of Presentation I. Introduction

More information

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP.

Role of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP. Role of IRB/IEC in GCP Benjamin Kuo, MD, Dr.PH, CIP. Institutional Review Board (IRB) An independent body constituted of medical, scientific and non scientific members Responsible for ensuring protection

More information

Extemporaneously Prepared Early Phase Clinical Trial Materials

Extemporaneously Prepared Early Phase Clinical Trial Materials Extemporaneously Prepared Early Phase Clinical Trial Materials Richard Hoffman, MS, RAC Eli Lilly & Co. Regulatory Advisor International Consortium for Innovation & Quality in Pharmaceutical Development

More information

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB)

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB) March 1, 2006 M E M O R A N D U M F O R R E C O R D TO: FROM: SUBJECT: Deans Department Chairs Principal Investigators Brian Herman, Ph.D. Vice President for Research Investigator responsibilities for

More information

UK Implementation of the EU Clinical Trial Directive 2001/20/EC:

UK Implementation of the EU Clinical Trial Directive 2001/20/EC: UK Implementation of the EU Clinical Trial Directive 2001/20/EC: GCP Aspects. Dr. Colin Wilsher, FRQA. BARQA GCP Committee Chairman; & Pfizer Worldwide Development Quality Assurance. GIQAR, Roma, October

More information

KINGDOM OF SAUDI ARABIA. Capital Market Authority CREDIT RATING AGENCIES REGULATIONS

KINGDOM OF SAUDI ARABIA. Capital Market Authority CREDIT RATING AGENCIES REGULATIONS KINGDOM OF SAUDI ARABIA Capital Market Authority CREDIT RATING AGENCIES REGULATIONS English Translation of the Official Arabic Text Issued by the Board of the Capital Market Authority Pursuant to its Resolution

More information

Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) Overview and Implementation

Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) Overview and Implementation Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) Overview and Implementation Connie Jung, RPh, PhD U.S. Food and Drug Administration NACDS Total Store Expo August 24, 2014

More information

U.S. Food and Drug Administration

U.S. Food and Drug Administration U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA s website for reference purposes only. It was current when produced, but is no longer maintained

More information

Introduction to the Medicines and Related Substances Act, 1965 (Act 101 of 1965): Setting the scene for Complementary Medicines Regulation

Introduction to the Medicines and Related Substances Act, 1965 (Act 101 of 1965): Setting the scene for Complementary Medicines Regulation Introduction to the Medicines and Related Substances Act, 1965 (Act 101 of 1965): Setting the scene for Complementary Medicines Regulation Prof Peter Eagles Chairperson Medicines Control Council of South

More information

Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions

Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions 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

More information

KINGDOM OF SAUDI ARABIA. Capital Market Authority CREDIT RATING AGENCIES REGULATIONS

KINGDOM OF SAUDI ARABIA. Capital Market Authority CREDIT RATING AGENCIES REGULATIONS KINGDOM OF SAUDI ARABIA Capital Market Authority CREDIT RATING AGENCIES REGULATIONS English Translation of the Official Arabic Text Issued by the Board of the Capital Market Authority Pursuant to its Resolution

More information

Site Initiation and Closeout

Site Initiation and Closeout 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

More information

Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects

Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects U.S. Department of Health and Human Services Food and Drug Administration Center for Drug

More information

Guidance on IRB Continuing Review of Research

Guidance on IRB Continuing Review of Research NOTE: THIS GUIDANCE SUPERSEDES OHRP S JANUARY 15, 2007 GUIDANCE ENTITILED GUIDANCE ON CONTINUING REVIEW. CLICK HERE FOR THE JANUARY 15, 2007 GUIDANCE. Office for Human Research Protections Department of

More information

Reporting of Adverse Events and Unanticipated Problems

Reporting of Adverse Events and Unanticipated Problems Reporting of Adverse Events and Unanticipated Problems Policy date: 12/2011 Purpose The purpose of this policy is to ensure that the review, reporting and analysis of adverse events and unanticipated problems

More information

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Estonia

The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Estonia The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Estonia Question 1: What laws or regulations apply to an application for conducting a clinical

More information

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:

More information

UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD EMERGENCY MEDICINE RESEARCH EXEMPTION FROM INFORMED CONSENT REQUIREMENTS

UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD EMERGENCY MEDICINE RESEARCH EXEMPTION FROM INFORMED CONSENT REQUIREMENTS UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD EMERGENCY MEDICINE RESEARCH EXEMPTION FROM INFORMED CONSENT REQUIREMENTS I. PURPOSE This document outlines the procedures for University

More information

Pest Control Products Act

Pest Control Products Act Pest Control Products Act CHAPTER P-9 An Act to regulate products used for the control of pests and the organic functions of plants and animals 1 Short title SHORT TITLE 1. This Act may be cited as the

More information

The Importance of Following the PROTOCOL in Clinical Trials

The Importance of Following the PROTOCOL in Clinical Trials The Importance of Following the PROTOCOL in Clinical Trials Presentation Objectives: Upon completion of this presentation, participants will be able to: Describe the following terms: Protocol, Protocol

More information

2011 No CONSUMER PROTECTION. The Toys (Safety) Regulations 2011

2011 No CONSUMER PROTECTION. The Toys (Safety) Regulations 2011 STATUTORY INSTRUMENTS 2011 No. 1881 CONSUMER PROTECTION The Toys (Safety) Regulations 2011 Made - - - - 24th July 2011 Laid before Parliament 29th July 2011 Coming into force - - 19th August 2011 The Secretary

More information

Bureau of Health Care Services. Compounding Pharmacy Law FAQ. (PA 280 of 2014)

Bureau of Health Care Services. Compounding Pharmacy Law FAQ. (PA 280 of 2014) Bureau of Health Care Services Compounding Pharmacy Law FAQ (PA 280 of 2014) 1. When does this new law come into effect? This new law is in effect beginning September 30, 2014. 2. Will I need to be licensed

More information

History and Principles of Good Clinical Practice

History 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 information

DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS DIRECTOR S OFFICE PHARMACY PROGRAM FOR UTILIZATION OF UNUSED PRESCRIPTION DRUGS

DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS DIRECTOR S OFFICE PHARMACY PROGRAM FOR UTILIZATION OF UNUSED PRESCRIPTION DRUGS DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS DIRECTOR S OFFICE PHARMACY PROGRAM FOR UTILIZATION OF UNUSED PRESCRIPTION DRUGS (By authority conferred on the director of the department of licensing and

More information

Regulations & Requirements for Conducting Clinical Trials on Drugs

Regulations & Requirements for Conducting Clinical Trials on Drugs Regulations & Requirements for Conducting Clinical Trials on Drugs Version 1.0 Date issued Date of implementation 08/07/2015 08/07/2015 1 [SFDA Regulations & Requirements for Conducting Clinical Trials

More information

Newfoundland and Labrador Pharmacy Board Standards of Practice. Professional Development for Pharmacists and Pharmacy Technicians

Newfoundland and Labrador Pharmacy Board Standards of Practice. Professional Development for Pharmacists and Pharmacy Technicians Newfoundland and Labrador Pharmacy Board Standards of Practice Professional Development for Pharmacists and Pharmacy Technicians updated September 2015 Table of Contents 1) Introduction and Overview...

More information

PI Name: PI Address: PI Phone No: Contracts Contacts: Contact Name: address: Phone Number:

PI Name: PI  Address: PI Phone No: Contracts Contacts: Contact Name:  address: Phone Number: A robust feasibility is an essential part of ensuring study delivery. Please pass this Study Feasibility Assessment and a copy of the Protocol to the individual(s) who are most appropriate to accurately

More information

Province of Alberta DRUG PROGRAM ACT. Statutes of Alberta, 2009 Chapter D-17.5. Assented to June 4, 2009. Published by Alberta Queen s Printer

Province of Alberta DRUG PROGRAM ACT. Statutes of Alberta, 2009 Chapter D-17.5. Assented to June 4, 2009. Published by Alberta Queen s Printer Province of Alberta Statutes of Alberta, Assented to June 4, Published by Alberta Queen s Printer Alberta Queen s Printer 5 th Floor, Park Plaza 10611-98 Avenue Edmonton, AB T5K 2P7 Phone: 780-427-4952

More information

2014 Terms and Conditions for support of grant awards

2014 Terms and Conditions for support of grant awards ENVIRONMENTAL PROTECTION AGENCY An Ghníomhaireacht um Chaomhnú Comhshaoil EPA Research Programme 2014-2010 2014 Terms and Conditions for support of grant awards Note: This document provides indicative

More information

Regulator s Role in GCP

Regulator s Role in GCP 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

More information

REGULATORY AND ETHICAL REQUIREMENTS FOR HERBAL MEDICINE

REGULATORY AND ETHICAL REQUIREMENTS FOR HERBAL MEDICINE REGULATORY AND ETHICAL REQUIREMENTS FOR HERBAL MEDICINE Hary Wahyu T. National Agency of Drug and Food Control Republic of Indonesia 13 TH FERCAP International Conference Sanur Beach Hotel, Sanur, Bali

More information

BUSINESS ENTITIES PART I LIMITED LIABILITY PARTNERSHIPS

BUSINESS ENTITIES PART I LIMITED LIABILITY PARTNERSHIPS BY-LAW 7 Made: May 1, 2007 Amended: June 28, 2007 September 20, 2007 (editorial changes) February 21, 2008 October 30, 2008 November 27, 2008 April 30, 2009 June 28, 2012 April 25, 2013 December 4, 2014

More information

Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. Lisa Austin, Research Manager

Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of GCP or the Trial Protocol sponsored CTIMP s. 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 information

INVESTIGATOR HANDBOOK

INVESTIGATOR HANDBOOK INVESTIGATOR HANDBOOK Liberty IRB, Inc. 1450 S. Woodland Blvd., Suite 300A Deland, Florida 32720 Phone (386) 279-4318 Fax: (386)868-4563 Website: www.libertyirb.com Business hours: Monday Friday, 8:00am

More information

The Ontario Cancer Research Ethics Board Overview

The Ontario Cancer Research Ethics Board Overview The Ontario Cancer Research Ethics Board Overview Research Ethics Research ethics review is vital to the advancement of ethically sound research. Before individuals can be enrolled in a research study,

More information