ORC Sponsor-Investigator IDE Checklist

Size: px
Start display at page:

Download "ORC Sponsor-Investigator IDE Checklist"

Transcription

1 A sponsor-investigator assumes BOTH investigator and sponsor responsibilities as outlined in the FDA Code of Federal Regulations 21CFR812. This means that such investigators have additional responsibilities. Use this checklist to verify sponsor and investigator responsibilities and best practices at the onset and during the course of your study. Note: It is the investigator s responsibility to review and familiarize themselves with FDA regulations outlined in 21CFR812 (as additional responsibilities are listed), Good Clinical Practice (GCP) Guidelines ICH E6, and any other regulations and policies that may apply. Additionally, if the device is made in your lab, you have to ensure Good Manufacturing Practice (GMP) compliance. See GCP ICH E6: Consolidated Guidance for additional information on conducting and maintaining records in clinical investigation, and Good Manufacturing Practice guidelines on Principal Investigator: IRB#: IRB Approval Date: Protocol Title: IDE#: Significant Risk (SR) Device OR Non-Significant Risk (NSR) Device (follows abbreviated IDE requirements) Date of Site Initiation Visit with sponsor monitor: SPONSOR RESPONSIBILITIES Sponsors are responsible for: 1. Selecting qualified investigators For each site investigator obtain: Signed Investigator Agreement CV or other statement of qualifications such as a professional license For covered clinical studies, written disclosure of any financial conflicts of interest (before, during and up to 1 year after the study including any changes) Ensure that each investigator is not disqualified from participating in research from the FDA disqualification database. 2. Ensuring proper monitoring of the investigation SR devices: select a monitor qualified by training and experience to monitor the study conducted under its IDE Monitor: CRO Other: All sites must have a monitoring log and maintain correspondence with the monitor See FDA Guideline for the Monitoring of Clinical Investigations Have a documented and adequate monitoring plan Secure compliance from all participating investigators with the signed agreement, investigational plan, applicable FDA regulations, or with condition of IRB or FDA approval In cases of continuing investigator non-compliance discontinue shipment of device, end investigator s participation in the investigation, and notify FDA NSLIJHS Office of Research Compliance Page 1 of 5

2 3. Promptly informing and reporting to FDA, IRB, and participating investigators SR devices: Submitting the IDE application to the FDA Obtaining FDA & IRB approval for the application or supplemental application before beginning an investigation or part of an investigation Submit to the FDA, at 6 month intervals, a current list of the names and addresses of all investigators participating in the investigation NSR devices: Obtaining IRB approval of the investigation as a non-significant risk device study and maintaining such approval Provide the FDA, investigator, and IRB with the investigational plan and report of prior investigations of the device Notify FDA and all reviewing IRBs and participating investigators of any withdrawal of approval of an investigation or a part of an investigation by a reviewing IRB within 5 working days after receipt of the withdrawal of approval. Notify all reviewing IRBs and participating investigators of any withdrawal of FDA approval of the investigation within 5 working days after receipt of notice. Conduct an evaluation of any unanticipated adverse device effect(s) and submit to FDA, all reviewing IRBs, and participating investigators with a report with the results from any evaluations conducted for an unanticipated adverse device effect within 10 working days after the sponsor is first notified Terminate all or parts of the investigation immediately if the device presents unreasonable and significant risk to subjects (within 5 working days after sponsor makes risk determination, and within 15 days after sponsor is first notified of device effect) SR devices: may not resume investigation without IRB and FDA approval NSR devices: may not resume investigation without IRB approval. If termination was for unanticipated adverse device effects, FDA approval must also be sought Submit to FDA a copy of any report by an investigator who uses a device without obtaining informed consent within 5 working days of receipt of notice. Submit annual progress reports to all reviewing IRBs, and for SR devices, to the FDA. Submit a final report to all reviewing IRBs, and for SR devices, to the FDA and participating investigators 4. Ensuring control and representation of the investigational device Ship devices only to qualified investigators participating in the investigation Maintain adequate records of shipment and disposition of devices. SR devices: records must include name and address of the consignee, type and quantity of device, date of shipment, and batch number or code mark. Records of disposition shall describe the batch number or code marks of any devices returned to the sponsor, repaired, or disposed of in other ways by the investigator or another person, and the reasons for and method of disposal. NSR devices: the name and intended use of the device and the objectives of the investigation; a brief explanation of why the device is a NSR device; the name and address of each investigator and the IRB that has reviewed the investigation; and a statement of the extent to which the good manufacturing practice regulation in part 820 will be followed in manufacturing the device NSLIJHS Office of Research Compliance Page 2 of 5

3 Ensure the investigational device bears a label with the following: Name and place of business of the manufacturer, packer or distributor in accordance with 21 CFR General Labeling Provisions Quantity of contents, if appropriate The statement: Caution: Investigational device. Limited by Federal (or United States) law to investigational use A description of all relevant contraindications, adverse effect, hazards, interfering substances or devices, warnings and precautions Must not include any statements that may be false or misleading, and should not represent the device as safe or effective for the purposes for which it is under investigation Notify FDA and all reviewing IRBs of any request that an investigator return, repair, or otherwise dispose of any units of a device within 30 days of request. Current Good Manufacturing Practices (cgmps): Ensure the minimum current good manufacturing practice of devices in compliance with 21 CFR 820, Quality System Regulation Other Responsibilities: Preparation, maintenance and distribution of study documents or manuals including Standard Operating Procedures (SOPs)/ Manual of Operating Procedures (MOP), Case Report Forms, device accountability forms, etc. Oversight of data management, data queries and preparation of reports for study operational or reporting purposes Maintaining records concerning adverse device effects (whether anticipated or unanticipated) and complaints Maintaining all regulatory documentation including original IDE application, required reports, and any other correspondence with another sponsor, monitor, investigator, IRB, or FDA Allowing the FDA, at reasonable times, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records or results from use of devices are kept), and inspect and copy all records relating to an investigation. NSLIJHS Office of Research Compliance Page 3 of 5

4 PRINCIPAL INVESTIGATOR RESPONSIBILITIES Each participating investigator is responsible for: 1. Conducting the study according to the signed investigator agreement, the investigational plan and applicable FDA regulations including: Only allowing subjects to participate after obtaining IRB and FDA approval Disclosing financial information to the sponsor Submitting progress reports, safety reports, final report to the sponsor and IRB Maintaining the protocol with documents showing dates of and reasons for each protocol deviation Only making changes in a protocol after notifying the sponsor and obtaining IRB approval, except when necessary to eliminate immediate hazards to human subjects Reporting protocol violations/deviations and unanticipated problems to the IRB and sponsor Reporting withdrawal of IRB approval to the sponsor 2. Protecting the rights, safety, and welfare of subjects under the investigator s care including: Personally conducting or supervising the described investigation(s) Obtaining informed consent from all human subjects receiving investigational device (unless exception requirements are met) and documenting this Reporting to the sponsor and reviewing IRB if a device was used without obtaining informed consent within 5 working days after the use occurs Promptly reporting to the sponsor and IRB of any unanticipated adverse device effect occurring during an investigation as soon as possible and within 10 days of learning of the effect. See FDA Guideline for Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects 3. Controlling devices under investigation including: Permitting a device to be used only with subjects under the investigator s supervision Maintaining adequate records of receipt, use or disposition of a device, including: Type and quantity, dates of its receipt, and batch number or code mark Names of all subjects who received, used, or disposed of each device Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of Return any remaining supply of the device to the sponsor or dispose of the device as instructed by sponsor 4. Preparing and maintaining accurate case histories or records and exposure to device for each subject including: Case Report Forms (CRFs) and supporting data (source documents) Signed and dated consent forms - For any use of a device by the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain consent. Medical records (e.g. physicians /nurses progress notes, individual hospital chart) NSLIJHS Office of Research Compliance Page 4 of 5

5 SR devices: Relevant observations including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each subject upon entering, and during the course of the investigation, including information about relevant previous medical history and the results of all diagnostic tests. A record of the exposure of each subject to the investigational device, including the date and time of each use, and any other therapy. Other Responsibilities: Maintaining all regulatory documentation including required reports and correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA. Allowing the FDA, at reasonable times, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records or results from use of devices are kept), and inspect and copy all records relating to an investigation. NSLIJHS Office of Research Compliance Page 5 of 5

[I.5.B.] [III.1.B.] [III.2.C.]

[I.5.B.] [III.1.B.] [III.2.C.] 1 1 1 1 1 1 1 1 0 1 HRPP Document: GUI0 [I..B.] [III.1.B.] [III..C.] Effective Date: 0/0/0 Revision Dates: 0-0-0, /1/0, /1/0 Subject: FDA Sponsor Requirements for Investigators Serving as Sponsors of Investigational

More information

Sponsor/Investigator Responsibilities

Sponsor/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 information

FDA Sponsor and Investigator Responsibility Checklist

FDA 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 information

Sponsor-Investigator Responsibilities In Clinical Trials

Sponsor-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 information

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

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

More information

Device research sponsors, whether companies or investigators, are held responsible for meeting the same regulations.

Device 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 information

APEC GCP Inspection Workshop May 29, 2008

APEC GCP Inspection Workshop May 29, 2008 Common Investigator Deficiencies Jean Toth-Allen, Ph.D. APEC GCP Inspection Workshop May 29, 2008 Most Common CI Deficiencies Failure to follow the investigational plan Protocol deviations Inadequate recordkeeping

More information

3.1. Overall Principal Investigator (PI), who holds the IDE and/or is the Sponsor

3.1. 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 information

Kathy Weil Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health US Food and Drug Administration

Kathy Weil Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health US Food and Drug Administration Kathy Weil Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health US Food and Drug Administration Kathy.Weil@fda.hhs.gov Follow the protocol and IDE regulations

More information

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

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

More information

POST-IRB APPROVAL FDA DRUG (IND) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR312)

POST-IRB APPROVAL FDA DRUG (IND) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR312) POST-IRB APPROVAL FDA DRUG (IND) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR312) Purpose: Investigators who initiate and submit an IND application to the FDA assume the responsibilities of both the

More information

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

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

More information

11.0 FDA-Regulated Research Research Involving Investigational Drugs and Biologics

11.0 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 information

Standard Operating Procedures Guidelines for Good Clinical Practice

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

More information

11.0 FDA-Regulated Research Research Involving Investigational Drugs and Biologics

11.0 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 information

11.0 FDA-Regulated Research

11.0 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 information

Human Research Protection Program Policy

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

More information

Title: Review of Medical Devices Page: 1 of 5 Written by:

Title: Review of Medical Devices Page: 1 of 5 Written by: THE NORTH SHORE MEDICAL CENTER Institutional Review Board (IRB) POLICIES AND PROCEDURES IRB Policy Number: 031.1 Title: Review of Medical Devices Page: 1 of 5 Written by: Approved by: Laura W. Knight,

More information

Investigator Manual Revised August 19, 2013

Investigator Manual Revised August 19, 2013 Investigator Manual Revised August 19, 2013 Investigator Manual Page 2 of 31 Table of Contents What is the purpose of this manual?... 3 What is Human Research?... 3 What is the Human Research Protection

More information

Investigator Manual. Human Subjects Protection Program

Investigator 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 information

Off-Label Use Congress and FDA must balance: The need to regulate manufacturer promotion of off-label use of devices; and The need for and availabilit

Off-Label Use Congress and FDA must balance: The need to regulate manufacturer promotion of off-label use of devices; and The need for and availabilit Off-Label Use Versus Clinical Trial Use of Devices: FDA Regulatory Issues Neil F. O Flaherty Principal Olsson Frank Weeda Terman Bode Matz PC Off-Label Use Uses that do not appear in a device s FDA-approved

More information

INVESTIGATIONAL DEVICE EXEMPTION APPLICATION. IDE Title (if title being used)

INVESTIGATIONAL 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 information

Clinical Trials Management for Molecular Diagnostics. April 2016

Clinical 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 information

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

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

More information

Human Research Protection Program Policy

Human Research Protection Program Policy Page 1 of 5 REVIEW OF INVESTIGATIONAL NEW DRUG (IND)/INVESTIGATIONAL DEVICE EXEMPTION (IDE) RESEARCH IN HUMAN SUBJECTS RESEARCH POLICY It is the policy of the University of Cincinnati that studies involving

More information

Implementing Good Clinical Practice at an Academic Research Institution

Implementing Good Clinical Practice at an Academic Research Institution Implementing Good Clinical Practice at an Academic Research Institution Maintaining Essential Documents Partners Human Research Quality Improvement (QI) Program Stephen W. Hayes Outline Significance of

More information

VCU Faculty Held IND and IDE Procedure Handbook

VCU Faculty Held IND and IDE Procedure Handbook VCU Faculty Held IND and IDE Procedure Handbook Contents A. Introduction... 3 B. Purpose of Institutional Oversight... 3 C. Applicability... 4 D. University Oversight of Clinical Investigations Being Conducted

More information

Good Clinical Practice Compliance

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

More information

UC Irvine s Clinical Research Coordinator Certification Preparation Series PI Roles and Responsibilities

UC Irvine s Clinical Research Coordinator Certification Preparation Series PI Roles and Responsibilities UC Irvine s Clinical Research Coordinator Certification Preparation Series PI Roles and Responsibilities BEVERLY ALGER, CCRP, CHRC Research Compliance Officer Office of Research Compliance November 2016

More information

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

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

More information

GCP Basics - refresher

GCP 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 information

HUMANITARIAN USE DEVICES 3/8/2016

HUMANITARIAN USE DEVICES 3/8/2016 DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program HUMANITARIAN USE DEVICES 3/8/2016 It is the policy of the Duke University Health System Institutional Review Board (DUHS IRB) to review and

More information

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

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

More information

I. Purpose. II. Definitions. Last Approval Date

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

More information

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

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

More information

Objectives Discuss the importance of proper data collection. Identify the types of data collected for clinical trials. List potential source documents

Objectives 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 information

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

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

More information

Demystifying Audits. Audits and Audit Preparation 5/23/2016. What is an Audit?

Demystifying Audits. Audits and Audit Preparation 5/23/2016. What is an Audit? Demystifying Audits Darlene Kitterman, MBA Director, Investigator Support & Integration Services OCTRI May 26, 2016 Audits and Audit Preparation What is an Audit? A systematic and independent examination

More information

Clinical Trials and the Code of Federal Regulations. Darlene Kitterman, MBA Director, Investigator Support & Integration Services September 24, 2014

Clinical Trials and the Code of Federal Regulations. Darlene Kitterman, MBA Director, Investigator Support & Integration Services September 24, 2014 Clinical Trials and the Code of Federal Regulations Darlene Kitterman, MBA Director, Investigator Support & Integration Services September 24, 2014 The Development of Regulations 1906: Food and Drugs Act

More information

Data Collection Tools Functions, Indicators & Sub-Indicators

Data Collection Tools Functions, Indicators & Sub-Indicators Data Collection Tools 27- Functions, Indicators & A. National regulatory system Indicator RS1: Legal framework for establishment of a regulatory system, mandate and enforcement power for each function

More information

1 Purpose. 2 Procedure. Title: FDA-Regulated Research. SOP Number: 1301 Effective Date: June 2, Previous Version Dates:

1 Purpose. 2 Procedure. Title: FDA-Regulated Research. SOP Number: 1301 Effective Date: June 2, Previous Version Dates: Previous Version Dates: Title: FDA-Regulated Research SOP Number: 1301 Effective Date: June 2, 2017 1 Purpose FDA regulations apply to research that involves a FDA-regulated test article in a clinical

More information

The Right Prescription for Working with Investigational Drug Service at BMC

The Right Prescription for Working with Investigational Drug Service at BMC The Right Prescription for Working with Investigational Drug Service at BMC Andrew Schoch Pharmacy Intern Northeastern University Class of 2010 Hyeseon Hong, Pharm.D. IDS Pharmacy Manager What is Investigational

More information

Stephanie Gentilin, CCRA

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

More information

INVESTIGATIONAL PRODUCT ACCOUNTABILITY, STORAGE, DISPENSING, TRANSPORT AND RETURN

INVESTIGATIONAL PRODUCT ACCOUNTABILITY, STORAGE, DISPENSING, TRANSPORT AND RETURN Policy/ Procedure # INVESTIGATIONAL PRODUCT ACCOUNTABILITY, STORAGE, DISPENSING, TRANSPORT AND RETURN 21 Effective Date June 2018 Category Global Last Review/Revision March 2017 Sub-Category Research Standards

More information

OFFICE FOR RESEACH PROCEDURE. Site Initiation and Close-out

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

More information

JI) C~ ~~cl MAR WARNING LETTER VIA FEDERAL EXPRESS

JI) C~ ~~cl MAR WARNING LETTER VIA FEDERAL EXPRESS JI) C~ ~~cl DEPART7VIENT OF HEAI:II-I & I-ICTNLAN SERVICES Public Health Service MAR 2 1 2001 Food and Drug Administration Center for Devices and Radiological Health 2098 Gaither Road WARNING LETTER Rockvilfe,

More information

ELEMENTS OF A DATA MONITORING PLAN

ELEMENTS OF A DATA MONITORING PLAN ELEMENTS OF A DATA MONITORING PLAN Definitions Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adherence to the approved investigative plan and

More information

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

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

More information

GCP INSPECTION FINDINGS Singapore Research Ethics Conference 2018

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

More information

Clinical Research with Drugs/Biologics and Devices & Good Clinical Practices

Clinical 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 information

Guidance for IRBs, Clinical Investigators and Sponsors

Guidance for IRBs, Clinical Investigators and Sponsors Guidance for IRBs, Clinical Investigators and Sponsors IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is

More information

13 FDA-Regulated Research

13 FDA-Regulated Research 13 FDA-Regulated Research FDA regulations apply to research that involves a FDA-regulated test article in a clinical investigation involving human subjects as defined by the FDA regulations. For FDA-regulated

More information

Investigational New Devices

Investigational New Devices Page 1 of 14 Investigational New Devices I. Purpose This document describes the policies and procedures for conducting studies involving investigational new devices at Stanford Hospital & Clinics (SHC)

More information

Investigator Manual HRP-103

Investigator Manual HRP-103 HRP-103 Revised October 04, 2016 Table of Contents 1. Introduction... 3 A. Scope... 3 B. Purpose of this manual... 3 C. Where to get additional information and answers to questions... 3 E. Human Research

More information

MCW Office of Research Standard Operating Procedure

MCW Office of Research Standard Operating Procedure MCW Office of Research Standard Operating Procedure USE AND STORAGE OF INVESTIGATIONAL DEVICES Unit: Applies to: Human Research Protections Program (HRPP), Office of Research MCW Faculty and Staff involved

More information

GOOD MANUFACTURING PRACTICES - AUDIT REPORT FORM AKA GMP Standards Program

GOOD MANUFACTURING PRACTICES - AUDIT REPORT FORM AKA GMP Standards Program GOOD MANUFACTURING PRACTICES - AUDIT REPORT FORM AKA GMP Standards Program HC USE ONLY File Number Date/Time of Receipt To be completed by an Independent 3 rd Party Auditor. GENERAL INFORMATION A. Submission

More information

To document the review procedures for a submission regarding compassionate/treatment use of investigational drugs, biologics and devices.

To document the review procedures for a submission regarding compassionate/treatment use of investigational drugs, biologics and devices. UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD COMPASSIONATE/TREATMENT USE OF MEDICAL DRUGS, BIOLOGICS AND DEVICES I. PURPOSE To document the review procedures for a submission

More information

The Institutional Review Board (IRB) Manual

The Institutional Review Board (IRB) Manual The Institutional Review Board (IRB) Manual Investigational Devices Policy Research that involves the use of investigational devices must conform to Food and Drug Administration (FDA) and Department of

More information

Investigator Site File Index (Medical Devices)

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

More information

1. POLICY STATEMENT: 2. BACKGROUND:

1. 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 information

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

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

More information

Good Clinical Practice

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

More information

4.2. Investigator Regulatory Binder: Files, usually a binder, maintained by the investigator at the investigative site.

4.2. 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 information

The Children s Hospital of Philadelphia Committees for the Protection of Human Subjects Policies and Procedures Determination of IND/IDE Requirement

The Children s Hospital of Philadelphia Committees for the Protection of Human Subjects Policies and Procedures Determination of IND/IDE Requirement Page: 1 of 8 I. PURPOSE II. III. IV. The purpose of this Standard Operating Procedure is to delineate when an investigator must obtain an Investigational New Drug (IND) or Investigational Device Exemption

More information

Quality Assurance QA STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits

Quality Assurance QA STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits Quality Assurance QA 601.01 STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick

More information

Source Documents and Regulatory Binders October 6, 2016

Source Documents and Regulatory Binders October 6, 2016 Source Documents and Regulatory Binders October 6, 2016 Lisa Wilson, Regulatory Lead, Clinical Trials Office and Mark Alger, CRC, Clinical Trials Office Essential Documents AKA: the stuff in the Reg Binder

More information

FDA-Regulated Research

FDA-Regulated Research Chapter 18: FDA-Regulated Research Chapter Contents 18.1 FDA-Regulated Research 18.2 Investigational Drugs 18.3 Investigational Medical Devices 18.4 Sponsor-Investigators 18.5 Humanitarian Use Devices

More information

QUALITY AGREEMENT. The following Agreement has been concluded between

QUALITY AGREEMENT. The following Agreement has been concluded between QUALITY AGREEMENT The following Agreement has been concluded between LLC LABORATORIES The contract laboratory and service provider 1625 Trinity Dr., Unit 11 Mississauga, Ontario Canada L5T 1W9 Hereinafter

More information

Maintaining your Investigational Device Exemption (IDE) with the FDA: Keys for Success. Jenna Stump, MS, CCRP Clinical Research Regulatory Specialist

Maintaining your Investigational Device Exemption (IDE) with the FDA: Keys for Success. Jenna Stump, MS, CCRP Clinical Research Regulatory Specialist Maintaining your Investigational Device Exemption (IDE) with the FDA: Keys for Success Jenna Stump, MS, CCRP Clinical Research Regulatory Specialist Agenda How an investigator should prepare and submit

More information

SUBJECT: INSTITUTIONAL REVIEW BOARD (IRB) - HUMANITARIAN USE DEVICES

SUBJECT: INSTITUTIONAL REVIEW BOARD (IRB) - HUMANITARIAN USE DEVICES This policy applies to the following entity(s): Children s Hospital of Wisconsin Children s Hospital and Health System, Inc. Administrative Policy and Procedure Children s Research Institute SUBJECT: INSTITUTIONAL

More information

Regulatory Binder: Set-up and Maintenance

Regulatory Binder: Set-up and Maintenance Regulatory Binder: Set-up and Maintenance Introduction Federal and state regulations, institutional policy, and good clinical and research practices require investigators to maintain documents related

More information

GCP Convergence Improves Transportability of Medical Device Clinical Data

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

More information

Investigator s Responsibility

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

More information

Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network for Research Professionals

Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network for Research Professionals ORIENTATION FOR NEW CLINICAL RESEARCH COORDINATORS Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network for Research Professionals Overall Agenda for Orientation Module 1: Introduction

More information

Investigator s Handbook

Investigator s Handbook Page 96 CHAPTER 11 Investigational Drugs, Agents, Biologics, and Devices Investigational Drugs/Investigational Biologics (Test Articles) A new drug/agent or biologic that is used in a clinical investigation.

More information

USE OF INVESTIGATIONAL DRUGS OR BIOLOGICS IN HUMAN SUBJECTS RESEARCH

USE OF INVESTIGATIONAL DRUGS OR BIOLOGICS IN HUMAN SUBJECTS RESEARCH Policy P.11 Written By: B. Laurel Elder Created: June 3, 2013 Edited Replaces 10-9-2009 Version P.11.4 USE OF INVESTIGATIONAL DRUGS OR BIOLOGICS IN HUMAN SUBJECTS RESEARCH A. Procedure Contents this procedure

More information

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

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

More information

Medical Device Labeling HealthPack 2004 Program

Medical Device Labeling HealthPack 2004 Program Medical Device Labeling HealthPack 2004 Program Elizabeth Kempen Overview Regulatory Agencies and Pathways Labeling Regulations General Medical Device Labeling Requirements Electronic Labeling FDA s Current

More information

Regulatory Binder Guidance

Regulatory Binder Guidance Regulatory Binder Guidance What is the purpose of a regulatory binder? Achieve and maintain regulatory compliance Ensure protection of human subjects and high standards of research Guidance for organization

More information

Quality Assurance in Clinical Trials

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

More information

Office for Human Subject Protection. University of Rochester

Office for Human Subject Protection. University of Rochester POLICY 1. Purpose Outline the responsibilities and regulatory requirements when conducting human subject research that involves the use of drugs, agents, biological products, or nutritional products (e.g.,

More information

CGMP Requirements for Investigational Products

CGMP Requirements for Investigational Products PREP #6 CGMP Requirements for Investigational Products Ji-Eun Kim, RPh, PhD Research Pharmacist Regulatory Affairs Office of Research Compliance December 6, 2016 1 CME Disclosure Statement Northwell Health

More information

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

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

More information

Introduction to Clinical Research

Introduction to Clinical Research Introduction to Clinical Research What is Clinical Research? Clinical research is medical research that involves people like you. People volunteer to participate in carefully conducted investigations that

More information

Subpart H [Reserved] Subpart I Expanded Access to Investigational Drugs for Treatment. 21 CFR Ch. I ( Edition)

Subpart H [Reserved] Subpart I Expanded Access to Investigational Drugs for Treatment. 21 CFR Ch. I ( Edition) 312.300 (c) Disposition of unused drug. The person who ships the drug under paragraph (a) of this section shall assure the return of all unused supplies of the drug from individual investigators whenever

More information

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

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

More information

ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

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

More information

PROTOCOL DRAFTING GUIDE

PROTOCOL 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 information

Source And Regulatory Documentation for DMID Clinical Studies

Source And Regulatory Documentation for DMID Clinical Studies Source And Regulatory Documentation for DMID Clinical Studies Walt Jones RN, MPH Nurse Consultant Clinical Monitoring Coordinator OCRA, DMID, NIAID November, 2007 Source Data Defined All information in

More information

Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators Journal of Diabetes Science and Technology Volume 5, Issue 2, March 2011 Diabetes Technology Society REVIEW ARTICLE Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

More information

Quality Assurance for the Research Team: Connecting Day-to-Day Operations to a Regulatory Framework

Quality 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 information

Regulatory Documentation and Submissions for C2012 Clinical Trials DCP SOP #1

Regulatory Documentation and Submissions for C2012 Clinical Trials DCP SOP #1 Regulatory Documentation and Submissions for C2012 Clinical Trials DCP SOP #1 Phone: 650.691.4400 Fax: 650.691.4410 Email: regulatory.ccsainc.com COMPLIANCE & STANDARDIZATION Rationale for Revision of

More information

BACKGROUND PURPOSE 9/24/2009 DATA AND SAFETY MONITORING

BACKGROUND PURPOSE 9/24/2009 DATA AND SAFETY MONITORING DATA AND SAFETY MONITORING September 2009 Joey Casanova, BBA, CIP Human Subject Research Office SECTION 1 BACKGROUND PURPOSE Data and safety monitoring is the process for reviewing accumulated outcome

More information

ROLE OF THE RESEARCH COORDINATOR Study Startup Best Practices May 2016

ROLE OF THE RESEARCH COORDINATOR Study Startup Best Practices May 2016 UCLA CTSI WELCOME TO ONLINE TRAINING FOR CLINICAL RESEARCH COORDINATORS ROLE OF THE RESEARCH COORDINATOR Study Startup Best Practices May 2016 Objectives Define the sponsor of a clinical trial and learn

More information

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

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

More information

Investigator-Initiated INDs

Investigator-Initiated INDs Investigator-Initiated INDs Marjorie Small, RN, CCRC Office of Clinical Research 23 May 2011 PPHS/IRB Research Grand Rounds Outline of Presentation I. What is an IND? II. Code of Federal Regulations III.

More information

STANDARD OPERATING PROCEDURE. STH Researcher. Investigator Site File

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

More information

FDA 101 Session: Care and Feeding of an Investigational New Drug (IND)

FDA 101 Session: Care and Feeding of an Investigational New Drug (IND) FDA 101 Session: Care and Feeding of an Investigational New Drug (IND) CAPT Kofi Ansah, PharmD, MS, MBA, RAC CAPT William Bender, RPh, MSHCA, RAC CDR Keith Kiedrow, PharmD, MS, RAC CDR Hiren Patel, PharmD,

More information

Conducted Under an IND to Support a

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

More information