WCG ACADEMY COURSE OVERVIEW
|
|
- Dayna Nelson
- 6 years ago
- Views:
Transcription
1 WCG ACADEMY COURSE OVERVIEW Investigator Course Title Documentation of Informed Consent Duration Ethical Principles Underlying Consent Documentation Long Form Short Form Consent Records Special Considerations o Children (Assent Documentation) o Adults Unable to Consent (Assent Documentation) o Non-English Speaking Adults (Consent Documentation) o Illiterate Subjects (Consent Documentation) Course Description: The informed consent process is an integral part of clinical research. In order for research to begin, documentation of a subject s informed consent must be obtained. This course helps explain the documentation needed. Informed Consent Process WCG 20 minutes Ethical Principles Underlying Consent General Consent Special Considerations o Children Assent o Parental Permission o Assent of Adults Unable to Consent o Consent of Legally Authorized Representatives Course Description: The course introduces the informed consent process and its integral part in clinical research. The informed consent process helps ensure subjects make informed decisions and their continued participation in research.
2 Investigator Obligations Ethical Principles Underlying Investigator Obligations Key Terms Resources Submit and Report Equitable Selection Vulnerable and Special Populations o Children o Pregnant Women and Fetuses o Prisoners o Adults Unable to Consent o Other Vulnerable Populations Additional Obligations Course Description: This course describes the responsibilities and obligations of investigators conducting research overseen by an Institutional Review Board (IRB). GCP/ICH Obligations of Sponsors, Monitors and Investigators (GCP01) This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. Obligations of a sponsor in conducting a clinical research programs Responsibilities of a monitor in conducting clinical investigations Obligations of an investigator in conducting clinical investigations Course Description: Addresses the obligations of sponsors, monitors and investigators who participate in clinical research governed by US FDA regulations and ICH guidelines. Communicates how human subjects are protected during clinical investigations to ensure their ongoing welfare.
3 Obligations of Investigators in Conducting Drug and Biologic Trials (GCP02) Research Phases Obligations of clinical investigators under GCP regulations Investigator s reporting and documentation requirements Investigator s obligation for product accountability Inspections the investigator should be prepared for Consequences of failing to comply with GCP obligations and HIPAA in the USA. Course Description: Addresses compliance with GCP regulations when conducting clinical trials for investigational new drug and biologics. Addresses the investigator s obligation to protect human subjects who participate in clinical trials, as well as, the handling of safety data, drug accountability, clinical reporting requirements and compliance with FDA regulations and ICH guidelines. Obligations of Investigators in Conducting Medical Device Trials (GCP03) 90 minutes Protocol Reporting Documentation Inspections Non-Compliance Course Description: Addresses requirements for conducting clinical trials for investigational premarket medical devices. Provides an overview of the clinical investigator s general and specific obligations to protect human subjects while providing valid data that sponsors may submit to regulatory authorities for approval. Introduction to documentation and reporting requirements, the inspection process, and the consequences for failure to comply with GCP guidelines.
4 IRB Member Course Title Introduction to the Criteria for IRB Approval Duration 15 minutes Criteria Approval Course Description: This course introduces the criteria needed for an Institutional Review Board (IRB) approval to conduct research on human subjects. Criteria for Approval 1: Risk 15 minutes Risk Minimizing Risk Course Description: Minimizing risk is always an integral part of protecting subjects during research. In order to reduce risks sound research procedures should be followed at all times. This course helps to identify ways to mitigate risk during research. Criteria for Approval 2: Risks and Benefits 20 minutes Benefits Analyzing Risks Course Description: Benefits and risks are analyzed when reviewing research. This course helps to recognize when these risks to subjects are reasonable in comparison to the potential benefit of the research.
5 Criteria for Approval 3: Equitable Selection 20 minutes Equitable vs. Equal Effects of Research Review Materials Course Description: There should be a fair sharing of the burdens and benefits of research. Each IRB member should consider the risks, benefits, purpose, setting, and involvement of vulnerable populations to decide when selection is equitable and when it is inequitable. This course helps determine whether the selection of subjects is equitable. Criteria for Approval 4: Informed Consent Obtain Consent Attributes Disclosures Course Description: After the IRB determines whether criteria 1 through 3 and 6 through 8 are met, the IRB should then evaluate the consent process. This course discusses the requirements of an approvable consent process. Criteria for Approval 5: Document Consent in Writing Documentation Different Forms Course Description: This course discusses the requirements of whether and how to document consent in writing.
6 Criteria for Approval 6: Safety of Subjects Monitor Research Review Information Course Description: Ensuring the safety of subjects is the most important part of research. This course discusses how to provide adequate research plans and provisions for monitoring the data collected to ensure the safety of subjects. Criteria for Approval 7: Privacy and Confidentiality Privacy Confidentiality Course Description: The IRB should review protocols to ensure they protect the privacy of subjects and maintain the confidentiality of data. This course discusses the ways that protocols can protect subjects privacy and maintain confidentiality of data. Criteria for Approval 8: Coercion of Vulnerable Populations Vulnerable Populations Safeguards Course Description: Research involving populations vulnerable to coercion or undue influence must include additional safeguards to protect their rights and welfare. This course discusses the recognition of vulnerable populations and steps that can be taken to protect their rights and welfare.
TOP 10 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING HUMAN SUBJECTS RESEARCH
Investigators Responsibility #1: Design and Implement Ethical Research Consistent with the Three Ethical Principles Delineated in The Belmont Report. The Belmont Report: Three Basic Ethical Principles:
More informationEthics 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 informationThe Role of the IRB in Clinical Trials: What Patients and Families Need to Know. Marjorie A. Speers, Ph.D. Executive Director, WCG Foundation
The Role of the IRB in Clinical Trials: What Patients and Families Need to Know Marjorie A. Speers, Ph.D. Executive Director, WCG Foundation 1 CAC2 Values v Put the children and their families first in
More informationHuman Research Protection Program. Investigator Manual
Human Research Protection Program Revised July 7, 2014 HRP-910 7/7/2014 2 of 10 Table of Contents What is the purpose of this manual?... 3 What is Human Research?... 3 What is the Human Research Protection
More informationSOCIAL & BEHAVIORAL TEMPLATE WITH INSTRUCTIONS: 2.0 Background / Literature Review / Rationale for the study:
SOCIAL & BEHAVIORAL TEMPLATE WITH INSTRUCTIONS: Use this template to prepare a document for SOCIAL AND BEHAVIORAL research with the information from the following sections. Depending on the nature of what
More information1 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 informationHuman 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 informationGOOD CLINICAL PRACTICE (GCP) Series Catalog
GOOD CLINICAL PRACTICE (GCP) Series Catalog CITI Program s GCP series consists of three basic courses and three refresher courses. The basic courses include: GCP for Clinical Trials with Investigational
More informationStreamlining IRB Procedures for Expanded Access
Streamlining IRB Procedures for Expanded Access Marjorie A. Speers, Ph.D. Executive Director, WCG Foundation Richard Klein Director, FDA Patient Liaison Program Office of Health and Constituent Affairs
More informationEthical Principles in Clinical Research
Ethical Principles in Clinical Research Christine Grady NIH Clinical Center Department of Bioethics No conflicts of interest. Views presented are mine and do not necessarily represent positions or policies
More information\\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 informationPREP Course 24: Defining the Differences between FDA and OHRP regulations. Presented by: Hallie Kassan Dorean Flores Office of the IRB
PREP Course 24: Defining the Differences between FDA and OHRP regulations Presented by: Hallie Kassan Dorean Flores Office of the IRB CME Disclosure Statement The North Shore LIJ Health System adheres
More informationAnnual Research Administrators Symposium IRB Compliance. Thursday, July 31, 2014
Annual Research Administrators Symposium IRB Compliance Thursday, July 31, 2014 Why IRB Compliance Is Required for Grant Submissions Topics to Cover Today What is an IRB? Why IRB review is required? Regulatory
More informationTop Ten Investigator Responsibilities When Conducting Human Subjects Research
Top Ten Investigator Responsibilities When Conducting Human Subjects Research Thanks to Ada Sue Selwitz, Univ. of Kentucky and PRIM&R (Public Responsibility in Medicine & Research) Investigator Responsibility
More informationAPPLICATION INSTRUCTIONS INSTITUTIONAL REVIEW BOARD. Revised January 2010 Page 1
APPLICATION INSTRUCTIONS INSTITUTIONAL REVIEW BOARD Revised January 2010 Page 1 The IRB Proposal Includes: 1. All documents, other than the informed consent form, should be understandable to an informed
More informationUniversity of the Virgin Islands Institutional Review Board (IRB) IRB Basics for Social Science Senior Seminar (STT/STX)
University of the Virgin Islands Institutional Review Board (IRB) IRB Basics for Social Science Senior Seminar (STT/STX) Ethics and Human Subject Protections Presented by: Olusola Ewulo, M.S. Director,
More informationHuman Research Protection Program Plan
Revised January 19, 2018 Table of Contents Human Research Protection Program Plan HRP-101 1/19/2018 2 of 13 Scope... 3 Purpose... 3 Definitions... 3 Agent... 3 Clinical Trial... 3 Engaged in Human Research...
More informationResearch: Ethics, Informed Consent, FDA, Off Label Use
Research: Ethics, Informed Consent, FDA, Off Label Use Nasim Hedayati, MD, FACS, RPVI Assistant Professor Division of Vascular and Endovascular Surgery University of California, Davis 2015 Phlebology Review
More informationAdvocate Health Care Network. Human Research Protection Program. Plan
Advocate Health Care Network Human Research Protection Program Plan Revised October 19, 2014 Page 1 Table of Contents Scope... 3 Purpose... 3 Definitions... 3 Clinical Trial... 3 Engaged in Human Research...
More informationHuman Subjects Protection: Training for Research Teams
Human Subjects Protection: Training for Research Teams Walter L. Calmbach MD MPH South Texas Ambulatory Research Network (STARNet) Dept. of Family & Community Medicine Univ. of Texas Health Science Center
More informationElyse I. Summers, J.D. President and CEO. Copyright 2018 AAHRPP All rights reserved.
Overcoming Challenges Faced by International IRBs Sharing of Best Practices Among IRBs: Breakout 6 Inaugural Singapore Research Ethics Conference March 1-2, 2018 Singapore Elyse I. Summers, J.D. President
More informationEffective Date: April 2014 Revision: September 29, 2017
TITLE: Standard Operating Procedure (SOP) Statement of Authority and Purpose NUMBER: NSHA REB-SOP-1-001 Effective Date: April 2014 Revision: September 29, 2017 Applies To: All REB members and Office Personnel
More information2013 Metrics on Human Research Protection Program Performance
2013 Metrics on Human Research Protection Program Performance Updated August 1, 2014 About the Metrics Improving the quality of human research protection programs (HRPP) is a top priority of AAHRPP. Effective
More informationTrends in Oversight of Human Research Protections?
Trends in Oversight of Human Research Protections? Greg Koski, PhD, MD Associate Professor, Harvard Medical School Senior Scientist, James Mongan Institute for Health Policy Former Director, Office for
More informationWhat is an IRB (Institutional Review Board)?
What is an IRB (Institutional Review Board)? The Belmont Report The Belmont Report on the Ethical Principles and Guidelines for the Protection of Human Subjects of Research was prepared by the National
More informationEthical Principles in Clinical Research. Disclaimer. Christine Grady Department of Bioethics NIH Clinical Center
Ethical Principles in Clinical Research Christine Grady Department of Bioethics NIH Clinical Center Disclaimer The views expressed are mine and do not necessarily represent the positions or policies of
More informationHuman Subjects Protection Program Plan
December 1, 2016 HRP-101 12/1/16 2 of 12 Table of Contents Scope... 3 Purpose... 3 Definitions... 3 Agent... 3 Clinical Trial... 3 Engaged in Human Research... 3 Human Research:... 4 Human Subject as Defined
More informationHuman Research Protection Program. Plan
Human Research Protection Program Plan Revised September 6, 2017 HRP-101 9/6/17 2 of 13 Table of Contents Scope... 3 Purpose... 3 Definitions... 3 Agent... 3 Clinical Trial... 3 Engaged in Human Research...
More informationHospital Authority (HA) Guide on Research Ethics (for Study Site & Research Ethics Committee)
Page 1 of 8 Hospital Authority (HA) Guide on Research Ethics (for Study Site & Version Effective Date 2 01/02/2015 Document Number HAHO-CE&TM-HA REC Author HA Head Office Steering Committee on Research
More informationVolunteering for Clinical Trials
Volunteering for Clinical Trials Volunteering for Clinical Trials When considering volunteering for a clinical trial, it is important to make an informed decision. Below are answers to frequently asked
More informationHuman Subjects Research: IRB Resources
Research Compliance Office Human Subjects Research: IRB Resources Kristin B. Frazier HRPP Educational Specialist IRB Resources June 4, 2008 Topics Stanford Institutional Review Boards (IRB) Charge of IRB
More informationUsing CITI Program Content: Good Clinical Practice (GCP)
Using CITI Program Content: Good Clinical Practice (GCP) CONTENT AUTHOR Jaime A. Arango, EdD, CIP CITI Program INTRODUCTION Like all CITI Program educational materials, the components of the GCP series
More informationConducted 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 informationIDENTIFYING & 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 information11.0 FDA-Regulated Research Research Involving Investigational Drugs and Biologics
11.0 FDA-Regulated Research The IRB evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More informationInvestigator Manual. Human Subjects Protection Program
Human Subjects Protection Program HRP-103, Revised June 1, 2015 HRP-103 06/01/2015 2 of 33 Table of Contents Scope... 3 What is the purpose of this manual?... 3 What is Human Research?... 3 What is the
More informationRules of Human Experimentation
Rules of Human Experimentation Elaine Larson CUMC IRB Chair Associate Dean for Research, School of Nursing Professor of Epidemiology, Mailman School of Public Health Oversight for Human Research Office
More information11.0 FDA-Regulated Research Research Involving Investigational Drugs and Biologics
11.0 FDA-Regulated Research The IRB evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More informationHow 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 informationHuman Research Protections Program Policies and Standard Operating Procedures
Human Research Protections Program Policies and Standard Operating Procedures Version Date: April 2018 Presbyterian Healthcare Services Human Research Protections Office and Institutional Review Board
More informationApplicability 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 informationCHECKLIST: Pre-review
11-5-2014 1 of 5 The purpose of this checklist is to provide support for IRB staff conducting pre-review. This checklist is to be completed by the IRB staff, signed, dated, and retained with the IRB protocol
More informationDevice research sponsors, whether companies or investigators, are held responsible for meeting the same regulations.
POLICY #: RCO-101 Page: 1 of 11 1. POLICY STATEMENT: A DF/HCC Investigator who holds an Investigational Device Exemption (IDE) or who is the Sponsor of the research has additional responsibilities that
More information3.1. Overall Principal Investigator (PI), who holds the IDE and/or is the Sponsor
POLICY #: RCO-101 Page: 1 of 11 1. POLICY STATEMENT: An Overall Principal Investigator (PI) who holds an Investigational Device Exemption (IDE) or who is the Sponsor of the research has additional responsibilities
More informationEU Clinical Trials Regulation 536/2014
EU Clinical Trials Regulation 536/2014 How to comply with Article 9: the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, of the clinical
More informationStandard 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 information11.0 FDA-Regulated Research
11.0 FDA-Regulated Research The HSC evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More informationClinical Research with Drugs/Biologics and Devices & Good Clinical Practices
Clinical Research with Drugs/Biologics and Devices & Good Clinical Practices Jason Jobson, BLS, CCRP Research Compliance Officer Oklahoma City VA Medical Center October 2017 Goals Investigational New Drug
More informationSponsor-Investigator Responsibilities In Clinical Trials
In Clinical Trials Margaret Huber, RN, BSN, CHRC Compliance Manager The lecturer has no conflicts for this presentation 9/23/2015 Objectives Define terms sponsor, investigator, and sponsor-investigator.
More informationEthics in CTs. The Role of the Regulator versus The Role of the REB
gust 22, 2007 8:45 11:45 gust 22, 2007 8:45 11:45 ADVANCED WORKSHOP : REVIEW OF Helping the people of Canada maintain and improve their health Aider les Canadiens et les Canadiennes à maintenir et à améliorer
More informationHuman Research Protection Program. Plan
Human Research Protection Program Plan Dated: September 4, 2014 HRP-101 9/4/2014 2 of 14 Table of Contents Scope... 3 Purpose... 3 Definitions... 3 Agent... 3 Clinical Trial... 3 Engaged in Human Research...
More informationClinical Trials Management for Molecular Diagnostics. April 2016
Clinical Trials Management for Molecular Diagnostics April 2016 Clinical Operations Responsibilities Accrue samples that have proper informed consent for use Retrospective cohorts Remnant samples Prospective
More informationProtocol Submission Form
Protocol Submission Form 1. Administrative Information Name of Submitting Party: Street: Province/State: Postal/Zip Code: Phone: ( ) E-mail Address: Fax: ( ) Other: ( ) Date: 2. General Study Information
More informationHUMAN RESEARCH PROTECTION PROGRAM PLAN
HUMAN RESEARCH PROTECTION PROGRAM PLAN HRP 101 June 2017 706-542-3199 irb@uga.edu https://research.uga.edu/hso/ Table of Contents Scope... 2 Purpose... 2 Definitions... 2 Agent... 2 Clinical Trial... 2
More informationEIGHT BASIC ELEMENTS OF INFORMED CONSENT
1/6 This guidance addresses: o Eight Basic elements of informed consent o Additional elements of informed consent o Other information required by the IRB EIGHT BASIC ELEMENTS OF INFORMED CONSENT Required
More informationSITE SUBMISSION FORM (SINGLE SITE)
*We accept study submissions by email, fax or mail. 1. STUDY INFORMATION A. Sponsor: Protocol.: Study Title: B. Study Type: Drug, Biologic or Dietary Supplement (please complete section C., then proceed
More informationQuality Assurance for the Research Team: Connecting Day-to-Day Operations to a Regulatory Framework
1 Quality Assurance for the Research Team: Connecting Day-to-Day Operations to a Regulatory Framework Mandy Morneault Research Compliance Monitor University of Washington Institute of Translational Health
More informationFDA Perspective on International Clinical Trials
FDA Perspective on International Clinical Trials Kassa Ayalew, M.D., M.P.H. Division of Clinical Compliance Evaluation (DCCE) Office of Scientific Investigations (OSI) Center for Drug Evaluation and Research
More informationGCP Basics - refresher
p. 01 GCP Basics - refresher Agenda: p. 02 Brief History of GCP GCP Regulations Principles of ICH E6 Sponsor Responsibilities Computer Systems Common Compliance Issues Brief History of GCP 3 Brief History
More informationWorld Medical Association Declaration of Helsinki
World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the
More informationEthical Oversight of Human Subject Research. Susan Burner Bankowski, MS,JD OHSU IRB Chair Director, Research Ethics Program
Ethical Oversight of Human Subject Research Susan Burner Bankowski, MS,JD OHSU IRB Chair Director, Research Ethics Program Mandate of the IRB Review all research involving human subjects performed by OHSU
More informationWMA Declaration of Helsinki - Ethical
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects Download the PDF file Adopted by the 18 th WMA General Assembly, Helsinki, Finland, June 1964 and amended
More informationAPPLICATION FORM. Application for a Recognised Research Ethics Committee (REC) Opinion on a Clinical Trial on a Medicinal Product for Human Use.
APPLICATION FORM Application for a Recognised Research Ethics Committee (REC) Opinion on a Clinical Trial on a Medicinal Product for Human Use. Form 1 This application form should be completed and submitted
More informationNorthwestern University HSPP Policy Manual Page 2 of 116
Northwestern University HSPP Policy Manual Page 2 of 116 POLICY FOR HUMAN SUBJECTS RESEARCH AT NORTHWESTERN UNIVERSITY 8 I. PREAMBLE: 8 II. OVERVIEW OF THE IRB, OPRS, AND THE HUMAN SUBJECT PROTECTION PROGRAM
More informationGW Policy on Human Research Protection Program
GW Policy on Human Research Protection Program 1. PURPOSE 1.1. This policy establishes the [Organization] s Human Research Protection Program (HRPP) and its commitment to protect the rights and welfare
More informationTroubleshooting Informed Consent. Sandra Meadows, MPH, CIP Office of Responsible Research Practices June 26, 2018
Troubleshooting Informed Consent Sandra Meadows, MPH, CIP June 26, 2018 2 Session Objectives Identify common submission screening questions Examine IRB-required modifications related to the consent process
More informationNational Health Research Systems and Regulations for Ethical Research in Indonesia
National Health Research Systems and Regulations for Ethical Research in Indonesia 1 SURIADI GUNAWAN NATIONAL COMMISSION ON ETHICS OF HEALTH RESEARCH, JAKARTA Priorities of the National Programme for Research
More information1. POLICY STATEMENT: 2. BACKGROUND:
POLICY #: RCO-201 Page: 1 of 5 1. POLICY STATEMENT: All Food and Drug Administration (FDA) regulated research conducted under an Investigational New Drug Application (IND) and managed within DF/HCC requires
More informationSponsor/Investigator Responsibilities
Sponsor/Investigator Responsibilities Marian Serge, RN Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health Food and Drug Administration Marian.Serge@fda.hhs.gov
More informationPARTICIPANT RIGHTS AND PRIVACY. Tammy Stewart, CHRC & Jenny Bernhard, CHPC, CHC
PARTICIPANT RIGHTS AND PRIVACY Tammy Stewart, CHRC & Jenny Bernhard, CHPC, CHC Presentation Outline By the end of this presentation, you will have an understanding of: The history which lead to current
More informationBiomedical Research on Human Participants
Ethical Guidelines for Biomedical Research on Human Participants Dr P Paul Kumaran MBBS, BA (Psychology), MPH Scientist E [Deputy Director Medical] National Institute for Research in Tuberculosis (ICMR)
More information4.2. Investigator Regulatory Binder: Files, usually a binder, maintained by the investigator at the investigative site.
POLICY #: RCO-203 Page: 1 of 7 1. POLICY STATEMENT: Essential regulatory documents will be on maintained for research sponsored by or conducted at Dana-Farber/Harvard Cancer Center (DF/HCC) to assure compliance
More informationUC DAVIS OFFICE OF RESEARCH AAHRPP Preparation UC Davis Human Research Part III Investigator Manual. Cindy Gates IRB Administration
UC DAVIS OFFICE OF RESEARCH AAHRPP Preparation UC Davis Human Research Part III Investigator Manual Cindy Gates IRB Administration What is the purpose of the INVESTIGATOR MANUAL? The manual is designed
More informationThe Human Biomedical Research Act: Compliance and Risks. A/Prof Goh Yeow Tee Singapore Research Ethics Conference
The Human Biomedical Research Act: Compliance and Risks A/Prof Goh Yeow Tee Singapore Research Ethics Conference Agenda Biomedical Research Regulations What is HBRA expectation? Local Research Landscape
More informationRESEARCH PERFORMANCE SITES AND COLLABORATIVE OFF-SITE RESEARCH
1. Overview RESEARCH PERFORMANCE SITES AND COLLABORATIVE OFF-SITE RESEARCH The ethical and regulatory requirements of The Ohio State University Human Research Protection Program (HRPP) apply to all research
More informationCompetent federal higher authority ("Bundesoberbehörde- BOB")
Nutrition/InterventionaI - GERMANY Competent authority Contact Details Contact Name 1 Competent federal higher authority ("Bundesoberbehörde- BOB") Contact Name 2 Federal Institute for Drugs and Medical
More informationGCP 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 informationResearch 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 informationS A I N T M A RY S E M I N A RY O C T O B E R 1 9,
IRB BASICS FOR ADMINISTRATORS S A I N T M A RY S E M I N A RY O C T O B E R 1 9, 2 0 1 6 JOHN CARROLL UNIVERSITY Catherine Anson, MA, CRA, CIM Director of Sponsored Research Assistant IRB Chair Carole
More informationINVESTIGATIONAL DEVICE EXEMPTION APPLICATION. IDE Title (if title being used)
INVESTIGATIONAL DEVICE EXEMPTION APPLICATION IDE Title (if title being used) Name of Sponsor Investigator, MD X Professor, Department Icahn School of Medicine at Mount Sinai Date of Submission Form version
More informationInstitutional Review Board. HRP Investigator Manual
Institutional Review Board HRP 103 - Investigator Manual Revised October 2015 Investigator Manual Page 2 of 50 Contents What is the purpose of this manual?... 4 What is Human Research?... 4 What is the
More informationICH GCP E6(R2): Changes? Yes Challenges? Not as Difficult as You May Fear Lorrie D. Divers, President QRCP Solutions, Inc.
ICH GCP E6(R2): Changes? Yes Challenges? Not as Difficult as You May Fear Lorrie D. Divers, President QRCP Solutions, Inc. 25 October 2017: University of Rochester Achieving High Quality Clinical Research
More informationLearning about Clinical Trials
Learning about Clinical Trials A Guide for Individuals and Their Loved Ones INTRODUCTION Clinical trials help researchers answer important medical questions, providing information that may help with the
More informationIRB HUMAN SUBJECTS PROTECTION PROGRAM STANDARD OPERATING PROCEDURES INSTITUTIONAL REVIEW BOARD
IRB INSTITUTIONAL REVIEW BOARD HUMAN SUBJECTS PROTECTION PROGRAM STANDARD OPERATING PROCEDURES REVISED: OCTOBER, Table of Contents Page # INTRODUCTION... 1 CONTACT INFORMATION... 2 PRINCIPLES, ROLES AND
More informationReturn of Results Aggregate and Individual
Return of Results Aggregate and Individual Jessica Scott, MD, JD Head of R&D Patient Engagement, Takeda David Leventhal Senior Director Clinical Innovation, Pfizer March 18, 2019 Disclaimer The views and
More informationAudit 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 informationINVESTIGATOR HANDBOOK
INVESTIGATOR HANDBOOK INVESTIGATOR HANDBOOK Table of Contents MISSION... 3 FIRST TIME SUBMISSION... 3 EDUCATIONAL REQUIREMENTS... 3 PRINCIPAL INVESTIGATOR NEW STUDY SUBMISSIONS... 4 VULNERABLE POPULATIONS...
More informationFDA Sponsor and Investigator Responsibility Checklist
FDA Sponsor and Investigator Responsibility Checklist Principal Investigator: Study Name: CPHS #: IND/IDE #: Name of IND/IDE holder: The following checklist is created based on the Sponsor and Investigator
More informationInstitutional Review Board Compliance Elizabeth City State University
Institutional Review Board Compliance Elizabeth City State University Michelle Moore, MBA Research Compliance Officer/IRB Administrator Office of Sponsored Programs, Contracts & Grants 110 McLendon Hall
More informationResearch Data Sharing and Security: The Challenges We Face. Jon Mark Hirshon, MD, PhD, MPH Senior Vice-Chair Institutional Review Board
Research Data Sharing and Security: The Challenges We Face Jon Mark Hirshon, MD, PhD, MPH Senior Vice-Chair Institutional Review Board start us off with your involvement with the IRB and the data security/privacy
More informationHANDBOOK 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 informationInstitutional Review Board (IRB)
Institutional Review Board (IRB) Melissa Miklos Program Manager miklosm@upmc.edu Institutional Review Board What is the IRB? Why does the IRB exist? Where is the IRB? Who is the IRB? When do you need the
More informationWMA Declaration of Helsinki Ethical Principles f or Medical Research Involving Human Subjects
WMA Declaration of Helsinki Ethical Principles f or Medical Research Involving Human Subjects Note: Modifications and insertions highlighted and compared to previous 2008 wording by Gillian Vale, Administrator,
More informationInvestigator Manual Revised September 5, 2017
Revised September 5, 2017 Table of Contents Investigator Manual HRP-103 9/5/17 2 of 46 Scope... 3 What is the purpose of this manual?... 3 What is Human Research?... 3 What is the Human Research Protection
More informationWhat s New in GCP? FDA Clarifies, Expands Safety Reporting Guidance
Vol. 9, No. 2, February 2013 Happy Trials to You What s New in GCP? FDA Clarifies, Expands Safety Reporting Guidance Reprinted from the Guide to Good Clinical Practice with permission of Thompson Publishing
More informationObjectives Discuss the importance of proper data collection. Identify the types of data collected for clinical trials. List potential source documents
Data Management in Clinical Trials Introduction to the Principles and Practice of Clinical Research January 24, 2011 Diane St. Germain, RN, MS, CRNP Nurse Consultant Division of Cancer Prevention National
More informationExpanded Access. to Investigational Drugs & Biologics. for Treatment Use
SJMHS Research Compliance Office Guidance Document Expanded Access to Investigational Drugs & Biologics for Treatment Use May 2015 1 Expanded Access to Investigational Drugs & Biologics for Treatment Use
More informationEU Regulatory Perspective
EU Regulatory Perspective Sensible Guidelines. Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency An agency of the European Union Disclaimer The views presented in this presentation/these
More informationPROTOCOL DRAFTING GUIDE
MUHC Research Ethics Board (Neurosciences & Psychiatry) Comité d éthique de la recherche du MUHC (Neurosciences & psychiatrie) PROTOCOL DRAFTING GUIDE LIST OF ITEMS TO BE INCLUDED IN A PROTOCL FOR RESEARCH
More informationRESEARCH DURING PUBLIC HEALTH EMERGENCIES- ETHICAL ISSUES
RESEARCH DURING PUBLIC HEALTH EMERGENCIES- ETHICAL ISSUES Prof. Suma Krishnasastry Prof of Medicine Govt. T. D. Medical College, Alappuzha, Kerala, INDIA Public health Emergency Hallmark of a Public Health
More information