FDA-Regulated Research

Size: px
Start display at page:

Download "FDA-Regulated Research"

Transcription

1 Research Compliance Office FDA-Regulated Research Jennifer S. Brown, RN IRB Education February 2008

2 Today s Topics FDA & OHRP integrated in HRPP What does FDA regulate? Scope of FDA regulations and comparison with OHRP Practical information for IRB members Resources January 2008 Research Compliance Office 2

3 Integrated within AAHRPP Element I.3.C. The Organization has and follows written policies and procedures for determining when studies meet the regulatory definitions of human research. Element I.3.F. The Organization includes in its Human Research Protection Program policies and procedures regarding the areas in which federal and state law differ, and provides guidance about regulatory compliance. Research Compliance Office 3

4 What does FDA regulate? FDA regulates Drugs, biologics & devices used in diagnosis, cure, mitigation, treatment or prevention of disease Clinical research that evaluates safety and effectiveness of FDA-regulated products (IND/IDE regulations) FDA approves (releases to market) products with labeling that summarizes safety and effectiveness, intended use & indications for use FDA exempts further clinical studies, that are conducted according to approved labeling, from IND/IDE regulations* All HS research with FDA-regulated products must undergo IRB review, even if exempt from IND/IDE regulations *Drug (IND) and device (IDE) regulations define and determine exemptions differently Research Compliance Office 4

5 Different Scope FDA (21 CFR ) IRBs that review clinical investigations regulated by the FDA under sections 505(i), 507(d), and 520(g) of the act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. OHRP/HHS (45 CFR ) All research involving human subjects conducted or supported by HHS or conducted in an institution that agrees to assume responsibility for the research in accordance with 45 CFR 46 regardless of the source of funding. Research Compliance Office 5

6 Major Similarities IRB membership requirements Event or UP reporting requirements IRB functions and operations IRB review of research, including expedited review procedures Criteria for IRB approval of research IRB records requirements General requirements for informed consent Research Compliance Office 6

7 Some Areas of Difference Definitions of human subjects, research, clinical investigation, sponsor, sponsorinvestigator, IRB Children s finding paragraph numbers Specific requirements for informed consent Emergency use, waivers, etc. Exemptions from IRB review Multi-institutional (FDA) and cooperative project (OHRP) projects Research Compliance Office 7

8 Some Definitions from FDA Human subject = An individual who is or becomes a subject in research as a recipient of a test article or as a control Clinical Investigation (research) = Any experiment that involves a test article and one or more human subjects that either... Meets requirements for prior submission to the FDA. IND IDE OR Need not meet requirements for prior submission to the FDA, but the results of which are intended NSR to be later submitted to, or held for inspection by, FDA as part of device off-label for marketing new use an application for a research or marketing permit. 510(k) application Research Compliance Office 8

9 Practical IRB Implications FDA Not allowed Waiver of documentation of consent (minimal risk) Not applicable Waiver of consent for military personnel OHRP Waiver or alteration of consent, waiver of assent or parental permission Waiver of documentation of consent (minimal risk) Waiver of documentation of consent (breach of confidentiality) Not applicable Consent document must state FDA may inspect records Emergency use of a test article Planned emergency research Not applicable Not applicable (Planned emergency research) Children s findings and paragraph numbers (light blue laminate) Children s findings and paragraph numbers (orange laminate) Research Compliance Office 9

10 References and Resources Comparison of FDA and HHS Human Subject Protection Regulations (FDA) Comparison of Regulations (OHRP) Investigational New Drug Application (21 CFR 312) cfm?cfrpart=312 Investigational Device Exemptions (21 CFR 812) cfm?cfrpart=812 STANFORD HRPP, Chapter 5 Light blue and orange laminates Research Compliance Office 10

2014 Metrics on Human Research Protection Program Performance

2014 Metrics on Human Research Protection Program Performance 2014 Metrics on Human Research Protection Program Performance Updated May 15, 2015 About the Metrics Improving the quality of human research protection programs (HRPP) is a top priority of AAHRPP. Effective

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

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

Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide

Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide U.S. Department of Health and Human Services Center for Drug Evaluation and

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

Pre-Questions. Mastering Clinical Research July 29, 2015

Pre-Questions. Mastering Clinical Research July 29, 2015 Pre-Questions Mastering Clinical Research July 29, 2015 1. To be compliant with SOP 2.1 Obtaining Informed Consent for greater than minimal risk interventional clinical trial, which Licensed Professional

More information

In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them

In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them In Vitro Diagnostic (IVD) Devices: How they Differ from Other Devices and How FDA Regulates Them IRB Education Conference, Columbia University April 2007 Sally Hojvat, Ph.D. Director of Microbiology Devices

More information

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Introduction The purpose of this module is to provide a basic understanding of the responsibilities of the principal

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

This policy applies to research administrators, investigators, research staff, Human Investigation Committee (HIC) members and HIC staff.

This policy applies to research administrators, investigators, research staff, Human Investigation Committee (HIC) members and HIC staff. REVIEW BY AN EXTERNAL INSTITUTIONAL REVIEW BOARD 233 1 of 5 PURPOSE The purpose of this policy is to establish a procedure for requesting authorization for an approved, external (non-beaumont) institutional

More information

AAHRPP DOCUMENT # 84 UNIVERSITY OF ALABAMA HUMAN RESEARCH PROTECTIONS PROGRAM FORM: NOTIFICATION TO IRB OF EMERGENCY USE OF A TEST ARTICLE

AAHRPP DOCUMENT # 84 UNIVERSITY OF ALABAMA HUMAN RESEARCH PROTECTIONS PROGRAM FORM: NOTIFICATION TO IRB OF EMERGENCY USE OF A TEST ARTICLE 1 AAHRPP DOCUMENT # 84 UNIVERSITY OF ALABAMA HUMAN RESEARCH PROTECTIONS PROGRAM FORM: NOTIFICATION TO IRB OF EMERGENCY USE OF A TEST ARTICLE Instructions Test Article means any drug, biological product,

More information

Guidance for Sponsors, Investigators, and Institutional Review Boards. Questions and Answers on Informed Consent Elements, 21 CFR 50.

Guidance for Sponsors, Investigators, and Institutional Review Boards. Questions and Answers on Informed Consent Elements, 21 CFR 50. Guidance for Sponsors, Investigators, and Institutional Review Boards Questions and Answers on Informed Consent Elements, 21 CFR 50.25(c) (Small Entity Compliance Guide) U.S. Department of Health and Human

More information

2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14

2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14 2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14 NDSU research may involve the collaboration or assistance of other research institutions, schools, hospitals, clinics, private

More information

Core Training Outline

Core Training Outline Core Training Outline Modules: 1) Study Design 2) PI Oversight 3) Financial Management 4) Study Operations 5) Recruitment & Retention 6) Informed Consent 7) Investigational Products 8) Subject Safety 9)

More information

Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff

Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not

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

SUBJECT: Principal Investigator Oversight POLICY: RA:HRPP:10.13

SUBJECT: Principal Investigator Oversight POLICY: RA:HRPP:10.13 SUBJECT: Principal Investigator Oversight POLICY: RA:HRPP:10.13 DATE EFFECTIVE: PAGE: 1 of 2 I. POLICY The Children s National Medical Center (CNMC) Human Research Protections Program (HRPP) recognizes

More information

RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS

RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS 1. Overview IRB approval and participant informed consent are required to collect biological specimens for research purposes. Similarly, IRB approval

More information

PMAs, 510(k)s, and Advanced IDE Topics

PMAs, 510(k)s, and Advanced IDE Topics PMAs, 510(k)s, and Advanced IDE Topics Kenneth J. Cavanaugh Jr., Ph.D. Scientific Reviewer Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health kenneth.cavanaugh@fda.hhs.gov

More information

Regulatory Binder Instructions 25 April 2016

Regulatory Binder Instructions 25 April 2016 Regulatory Binder Instructions 25 April 2016 Instructions This Regulatory Binder is available to help study sites achieve and maintain regulatory compliance and adhere to high standards of practice in

More information

UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH PROTECTIONS PROGRAM. DoD/DON-funded Research

UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH PROTECTIONS PROGRAM. DoD/DON-funded Research UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH PROTECTIONS PROGRAM DoD/DON-funded Research Policy In 2006, the Department of the Navy (DON) enhanced its human subject protection requirements, including

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

Evaluation Instrument for Accreditation January 1, 2015

Evaluation Instrument for Accreditation January 1, 2015 Evaluation Instrument for Accreditation January 1, 2015 Copyright 2002-2014 AAHRPP. All rights reserved. Use of the Evaluation Instrument for Accreditation The Evaluation Instrument for Accreditation is

More information

Overview of FDA Compliance for Medical Devices

Overview of FDA Compliance for Medical Devices Glisland Training Series: Overview of FDA Compliance for Medical Devices Glisland, Inc. San Jose, California, USA http://www.glisland.com Description This course provides a concise overview of how FDA

More information

STANDARD OPERATING POLICY AND PROCEDURE

STANDARD OPERATING POLICY AND PROCEDURE STANDARD OPERATING POLICY AND PROCEDURE SUBJECT: Biospecimen Request and Release Policy Number: 500.0 Policy Date: 1/16/2009 Amendment Date: N/A Revision Date: 5-3-2010 I. INTRODUCTION AND PURPOSE The

More information

Investigator Initiated Research: Risks, Responsibilities, and Rewards. Lori T. Gilmartin BUMC GCRC RSA Support Research Consultant

Investigator Initiated Research: Risks, Responsibilities, and Rewards. Lori T. Gilmartin BUMC GCRC RSA Support Research Consultant Investigator Initiated Research: Risks, Responsibilities, and Rewards Lori T. Gilmartin BUMC GCRC RSA Support Research Consultant A Growing Concern PhRMA recently reported that spending on IIR had increased

More information

Guidance for Industry

Guidance for Industry Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer U.S. Department of Health and Human Services Food and Drug Administration Center

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

DHHS/NIH/OD/OIR/OHSRP 1/2/2015

DHHS/NIH/OD/OIR/OHSRP 1/2/2015 DHHS/NIH/OD/OIR/OHSRP 1/2/2015 The audience for this course is Principal Investigators (PIs), investigators and Research Coordinators (RCs) serving on the study team of human clinical studies and trials.

More information

Special Considerations for Pediatric Trials

Special Considerations for Pediatric Trials Special Considerations for Pediatric Trials Clinical research with minors poses several significantly different issues than research conducted on adults. Therefore, researchers must address a number of

More information

INVESTIGATOR MANUAL. Table of Contents

INVESTIGATOR MANUAL. Table of Contents Table of Contents HRP-910 001 10 Sep 2014 Page 1 of 7 What is the purpose of this manual?... 2 What is Human Research?... 2 What is the Human Research Protection Program?... 2 What training does my staff

More information

The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial

The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial 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

More information

Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues

Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues This guidance represents

More information

Evaluation Instrument for Accreditation January 1, 2016

Evaluation Instrument for Accreditation January 1, 2016 Evaluation Instrument for Accreditation January 1, 2016 Copyright 2002-2014 AAHRPP. All rights reserved. Use of the Evaluation Instrument for Accreditation The Evaluation Instrument for Accreditation is

More information

SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS

SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS BACKGROUND SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS The first priority of the SDCCD Institutional Review Board (IRB)

More information

University of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol

University of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol University of Hawai i Human Studies Program Guidelines for Developing a Clinical Research Protocol Following are guidelines for writing a clinical research protocol for submission to the University of

More information

Minimum Education Requirements for DoD Personnel Involved in Human Research Protection

Minimum Education Requirements for DoD Personnel Involved in Human Research Protection Minimum Education Requirements for DoD Personnel Involved in Human Research Protection The Department of Defense (DoD) is committed to conducting high-quality and ethical research, development, test, and

More information

AAHRPP Standards. Investigator Responsibilities for Research Involving Human Subjects

AAHRPP Standards. Investigator Responsibilities for Research Involving Human Subjects AAHRPP Standards Investigator Responsibilities for Research Involving Human Subjects Regulatory Landscape 2 AAHRPP OHRP FDA Pennington Louisiana Laws The Association for the Accreditation of Human Research

More information

Investigator Handbook to Human Research Activities. South Shore Hospital

Investigator Handbook to Human Research Activities. South Shore Hospital Investigator Handbook to Human Research Activities South Shore Hospital 1 INVESTIGATOR HANDBOOK CONTENTS WHO IS INVOLVED IN RESEARCH Principal Investigator... 6 Site PI 6 Co-investigators 6 Biostatistician

More information

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Frequently Asked Questions About Medical Devices Additional copies are available from: Office of Good Clinical Practice Office

More information

Post-Approval Compliance Monitoring: A Responsibility of the Human Research Protection Program (but how to do it?)

Post-Approval Compliance Monitoring: A Responsibility of the Human Research Protection Program (but how to do it?) Post-Approval Compliance Monitoring: A Responsibility of the Human Research Protection Program (but how to do it?) Monika S. Markowitz, PhD Director, Office of Education and Compliance Oversight Office

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

Policy on Human Subject Protection Training, Certification and Recertification at AUB

Policy on Human Subject Protection Training, Certification and Recertification at AUB Policy on Human Subject Protection Training, Certification and Recertification at AUB Policy Number: 005 Draft Version Number: 1 Dated: Prepared and Edited by: Mona Nabulsi and Mary Ellen Sheridan (Consultant)

More information

Documentation of the Informed Consent Process. USC Office for the Protection of Research Subjects (OPRS)

Documentation of the Informed Consent Process. USC Office for the Protection of Research Subjects (OPRS) Documentation of the Informed Consent Process USC Office for the Protection of Research Subjects (OPRS) Session Overview Highlights: Purpose of Informed Consent (IC) IC Process and Documentation Witness

More information

Department of Defense INSTRUCTION

Department of Defense INSTRUCTION Department of Defense INSTRUCTION NUMBER 6200.02 February 27, 2008 SUBJECT: Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs USD(P&R) References:

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

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 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

More information

Use of Electronic Informed Consent in Clinical Investigations Questions and Answers Guidance for Industry

Use of Electronic Informed Consent in Clinical Investigations Questions and Answers Guidance for Industry Use of Electronic Informed Consent in Clinical Investigations Questions and Answers Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments

More information

Guidance for IRBs, Clinical Investigators, and Sponsors

Guidance for IRBs, Clinical Investigators, and Sponsors Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review after Clinical Investigation Approval U.S. Department of Health and Human Services Food and Drug Administration Center for

More information

WHEN I WANT TO: I NEED TO SUBMIT: {for CIRB studies, see the specific FAQ}

WHEN I WANT TO: I NEED TO SUBMIT: {for CIRB studies, see the specific FAQ} IRB forms and materials to be submitted WHEN I WANT TO: I NEED TO SUBMIT: {for CIRB studies, see the specific FAQ} 1 2 Request a determination as to whether AHC is the appropriate IRB of record (i.e. is

More information

Comprehensive Study Documents List (Biomedical Studies)

Comprehensive Study Documents List (Biomedical Studies) Comprehensive Study Documents List (Biomedical Studies) Investigators conducting human subjects research must maintain study documents in adherence to federal and state regulations, USC policies, and good

More information

Memorandum. Factual Background

Memorandum. Factual Background Memorandum TO: FROM: SUBJECT: Chris Ianelli and Jill Mullan, ispecimen, Inc. Kristen Rosati and Ana Christian, Polsinelli, PC ispecimen Regulatory Compliance DATE: January 26, 2014 You have asked us to

More information

CHAPTER 48 Bioresearch Monitoring

CHAPTER 48 Bioresearch Monitoring FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7348.809 CHAPTER 48 Bioresearch Monitoring SUBJECT: INSTITUTIONAL REVIEW BOARDS REVISION: IMPLEMENTATION November 28, 2011 COMPLETION

More information

IDE Requirements for Diagnostic Tests Used in Clinical Trials

IDE Requirements for Diagnostic Tests Used in Clinical Trials IDE Requirements for Diagnostic Tests Used in Clinical Trials J. Milburn Jessup, MD Diagnostics Evaluation Branch Cancer Diagnosis Program DCTD, NCI, NIH jessupj@mail.nih.gov Outline Background Uses of

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use Qs & As DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

OPERATING PROCEDURES

OPERATING PROCEDURES OPERATING PROCEDURES CATEGORY: RESEARCH AFFAIRS CODE: H-27A APPROVED: 8/17/2010 SUBJECT: PROCEDURES FOR CONDUCT OF CONVENED IMPLEMENTED: 11/2010 REPLACES: PAGE: 1 of 6 Please note: Definitions are found

More information

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Study Start-up

More information

Use of Electronic Health Record Data in Clinical Investigations

Use of Electronic Health Record Data in Clinical Investigations Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

HIPAA Basics for Clinical Research

HIPAA Basics for Clinical Research HIPAA Basics for Clinical Research Audio options: Built-in audio on your computer OR Separate audio dial-in: 415-930-5229 Toll-free: 1-877-309-2074 Access Code: 960-353-248 Audio PIN: Shown after joining

More information

BUMC Clinical Research Seminar: What would YOU do? Put your IRB hat on!

BUMC Clinical Research Seminar: What would YOU do? Put your IRB hat on! BUMC Clinical Research Seminar: What would YOU do? Put your IRB hat on! Mary-Tara Roth, RN, MSN, MPH BUMC Clinical Research Resources Office (CRRO) Mary Banks, RN, BSN Senior Analyst II, BUMC IRB September

More information

Aurora Health Care. Clinical Trials. Medicare Part A & B Contractor Prior Notification of Humanitarian Use Devices & HUD Claims

Aurora Health Care. Clinical Trials. Medicare Part A & B Contractor Prior Notification of Humanitarian Use Devices & HUD Claims PROCEDURE STATEMENT: All Aurora Health Care employees have a responsibility to maintain a high level of integrity in the billing process, including prior claim submission notification to either Medicare

More information

PREP Course #27: Medical Device Clinical Trial Management

PREP Course #27: Medical Device Clinical Trial Management PREP Course #27: Medical Device Clinical Trial Management Presented by: Evelyn Huang Jeffrey Revello Office of Research Compliance North Shore-LIJ Health System CME Disclosure Statement The North Shore

More information

EVALUATION BRIEF Understanding the Institutional Review Board (IRB) January 2008

EVALUATION BRIEF Understanding the Institutional Review Board (IRB) January 2008 1 Serving the public and non-profit sectors through independent program evaluation, applied research, and technical assistance. EVALUATION BRIEF Understanding the Institutional Review Board (IRB) January

More information

Human Subjects Research at OSU

Human Subjects Research at OSU Office of Responsible Research Practices 300 Research Foundation 1960 Kenny Road Columbus, OH 43210-1063 Human Subjects Research at OSU Phone (614) 688-8457 Fax (614) 688-0366 www.orrp.osu.edu Behavioral

More information

INSTITUTIONAL REVIEW BOARD

INSTITUTIONAL REVIEW BOARD INSTITUTIONAL REVIEW BOARD Policies and Procedures Manual January 2015 Revision 5.0 TABLE OF CONTENTS 1.0 Purpose, Regulatory Overview, and Institutional Policy 1.1 Introduction and Purpose 1.2 Laws, Regulations,

More information

Clinical Investigator Inspections and FDA-483 Observations

Clinical Investigator Inspections and FDA-483 Observations Clinical Investigator Inspections and FDA-483 Observations Nancy A. Bellamy, Investigator Bioresearch Specialist/ BIMO Coordinator FDA Detroit District Office October 2, 2013 Objectives Background on FDA

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

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA): FACT SHEET FOR NEUROPSYCHOLOGISTS Division 40, American Psychological Association

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA): FACT SHEET FOR NEUROPSYCHOLOGISTS Division 40, American Psychological Association HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA): FACT SHEET FOR NEUROPSYCHOLOGISTS Division 40, American Psychological Association DISCLAIMER This general information fact sheet is made available

More information

Guidance for Industry and FDA Staff

Guidance for Industry and FDA Staff Guidance for Industry and FDA Staff Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution

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

CenterWatch. volunteering. clinical trial. for a. www.centerwatch.com

CenterWatch. volunteering. clinical trial. for a. www.centerwatch.com volunteering for a clinical trial www.centerwatch.com :: about this pamphlet This pamphlet provides an overview of the clinical trials process and answers frequently asked questions that many potential

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

OECD Recommendation on the Governance of Clinical Trials

OECD Recommendation on the Governance of Clinical Trials OECD Recommendation on the Governance of Clinical Trials Marketing authorisation status of the medicinal products Non-authorised medicine Authorised medicine, treatment regimen outside

More information

Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards

Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review

More information

Please provide the following information for our Pediatric Endocrine and Diabetes Database: (Parent s complete this form for your diabetic child)

Please provide the following information for our Pediatric Endocrine and Diabetes Database: (Parent s complete this form for your diabetic child) Please provide the following information for our Pediatric Endocrine and Diabetes Database: (Parent s complete this form for your diabetic child) Name: Parent s Name (if under 18 years of age): Address

More information

Human Subjects Research (HSR) Series

Human Subjects Research (HSR) Series Human Subjects Research (HSR) Series CITI Program s HSR series consists of modules from two basic tracks, Biomedical (Biomed) and Social- Behavioral- Educational (SBE), and a set of Additional Modules

More information

HIPAA Privacy Compliance Plan for Research. University of South Alabama IRB Guidance and Procedures

HIPAA Privacy Compliance Plan for Research. University of South Alabama IRB Guidance and Procedures HIPAA Privacy Compliance Plan for Research University of South Alabama IRB Guidance and Procedures Office of Research Compliance and Assurance CSAB 140 460-6625 Adopted: 4/2/2003 2 HIPAA PRIVACY COMPLIANCE

More information

Essential Standard Operating Procedures Sample Templates Table of Contents

Essential Standard Operating Procedures Sample Templates Table of Contents Essential Standard Operating Procedures Sample Templates Table of Contents Introduction Study Conduct and Good Clinical Practice 1: JHM Training/Certification Documentation 2: Delegation of Responsibility

More information

Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers

Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers ITHS Clinical Research Education Series September 7, 2010 Objectives Understanding the requirements of DHHS

More information

Data Management DM STANDARD OPERATING PROCEDURE FOR Data Management

Data Management DM STANDARD OPERATING PROCEDURE FOR Data Management Data Management DM 401.00 STANDARD OPERATING PROCEDURE FOR Data Management Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell, MD, FACP

More information

Expanded Access Programs. Richard Klein Office of Special Health issues Food and Drug Administration

Expanded Access Programs. Richard Klein Office of Special Health issues Food and Drug Administration Expanded Access Programs Richard Klein Office of Special Health issues Food and Drug Administration Expanded Access Programs (EAPs) What is expanded access? History Legislative background General principles

More information

DATA BREACHES: HOW TO AVOID THEM AND WHAT TO DO IF IT HAPPENS. Emory IRB Webinar January 8, 2015

DATA BREACHES: HOW TO AVOID THEM AND WHAT TO DO IF IT HAPPENS. Emory IRB Webinar January 8, 2015 DATA BREACHES: HOW TO AVOID THEM AND WHAT TO DO IF IT HAPPENS Emory IRB Webinar January 8, 2015 ACKNOWLEDGMENTS Thanks to Kris West for the information provided for this webinar DEFINITIONS Protected Health

More information

Investigator-initiated clinical trials are

Investigator-initiated clinical trials are A Program to Provide Regulatory Support for Investigator-Initiated Clinical Research Harvey M. Arbit, PharmD, MBA, and Mark S. Paller, MD, MS Abstract Investigator-initiated clinical trials represent a

More information

11/10/2011. History of CBUs. 10-CBA providing access to unlicensed cord blood units. The FDA s involvement. The FDA s involvement, cont.

11/10/2011. History of CBUs. 10-CBA providing access to unlicensed cord blood units. The FDA s involvement. The FDA s involvement, cont. History of CBUs First CBU transplant done in 1988 10-CBA providing access to unlicensed cord blood units Using the NMDP IND to access unlicensed cord blood units Amy Hays, Sr. Clinical Research Specialist,

More information

O n Sept. 8, 2015, the U.S. Department of Health and

O n Sept. 8, 2015, the U.S. Department of Health and Life Sciences Law & Industry Report Reproduced with permission from Life Sciences Law & Industry Report, 09 LSLR 1303, 11/13/15. Copyright 2015 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com

More information

Business Associate Agreement

Business Associate Agreement Business Associate Agreement This Business Associate Agreement (the Agreement ) is made by and between Business Associate, [Name of Business Associate], and Covered Entity, The Connecticut Center for Health,

More information

Catherine Jahrsdorfer, RN, BSN Director of Clinical Services USF Health Office of Clinical Research

Catherine Jahrsdorfer, RN, BSN Director of Clinical Services USF Health Office of Clinical Research A Practical Guide on Applying USF HRPP P&Ps in the Clinical Setting Catherine Jahrsdorfer, RN, BSN Director of Clinical Services USF Health Office of Clinical Research Learning Objectives Recognize the

More information

Winthrop-University Hospital

Winthrop-University Hospital Winthrop-University Hospital Use of Patient Information in the Conduct of Research Activities In accordance with 45 CFR 164.512(i), 164.512(a-c) and in connection with the implementation of the HIPAA Compliance

More information

Research Institute Administration

Research Institute Administration PROTOCOL DEVIATIONS 229 1 of 7 PURPOSE The purpose of this policy is to define protocol deviations and the subsequent actions required by the Principal Investigator (PI) once a protocol deviation occurs

More information

Nova Southeastern University Institutional Review Board Policies and Procedures

Nova Southeastern University Institutional Review Board Policies and Procedures Page 1 of 14 Purpose: To establish policy with respect to the emergency use of unapproved drugs and biologics. Definitions: 1. IRB approval means the determination of the IRB that the research has been

More information

Guidance on IDE Policies and Procedures

Guidance on IDE Policies and Procedures Guidance on IDE Policies and Procedures This document is intended to provide guidance. It represents the Agency s current thinking on the above. It does not create or confer any rights for or on any person

More information

Clinical Investigator Training Course

Clinical Investigator Training Course Clinical Investigator Training Course Investigator Responsibilities in Biomedical Research Covered by FDA Regulations Lisa Zimmerman Objectives Discuss Clinical Investigator Obligations according to FDA

More information

Social Media, Research, and Ethics: Challenges and Strategies

Social Media, Research, and Ethics: Challenges and Strategies Social Media, Research, and Ethics: Challenges and Strategies Elizabeth A. Buchanan, Ph.D. Endowed Chair in Ethics University of Wisconsin-Stout Presentation for The Department of Energy and the University

More information

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Institutional Review Board Inspections Additional copies are available from: Office of Good Clinical Practice Office of Special

More information

A Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky

A Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky 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

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

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

Top Ten Investigator Responsibilities When Conducting Human Subjects Research

Top 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 information

Quality Considerations for Breakthrough Therapies-FDA Perspective

Quality Considerations for Breakthrough Therapies-FDA Perspective Quality Considerations for Breakthrough Therapies-FDA Perspective DIA June 17, 2014 Ramesh K. Sood, Ph.D. Acting Division Director and Angelica Dorantes, Ph.D. xxx ONDQA/OPS/CDER/FDA 1 Background Outline

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