FDA: 3/21/05 Computerized Adverse Event Reporting (CAER) Office of Regulatory Affairs Georgetown University Medical Center Washington, DC Sorell L. Schwartz,

Slides:

Advertisements

Similar presentations

The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.

Advertisements

Managing Compliance Related to Human Subjects Research Review Joseph Sherwin, Ph.D. Office of Regulatory Affairs University of Pennsylvania Fourth Annual.

IRB Application Process Deb Schneider IRB Administrator Office of Research & Sponsored Programs 1055 AB (313)

Content of Regulatory/Study Binder Human Subject Protection Office UConn Health Center Monika Haugstetter, MHA, RN, MSN & HSPO/IRB Staff.

Pharmacovigilance Dr. Muiris Dowling,

4/30/20151 Quality Assurance Overview. 4/30/20152 Quality Assurance System Overview FY 04/05- new Quality Assurance tools implemented, taking into consideration.

L Committee Members »Walt Eversman, Rakesh Gudavarthy, K. Krishnamurthy (Chair), Don Madison, Don Myers, Randy Stoll, Keith Strassner l Charge »Develop.

Multi-Institutional Facilitated IRB Review Philip A. Cola, MA Vice President, Research and Technology University Hospitals Case Medical Center Third Annual.

Submission to Approval What happens to my protocol once I submit it to the HIC office.

ANPRM Single IRB Review mandated for multi-site domestic research P. Pearl O’Rourke, M.D. Partners Health Care.

Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary’s Advisory Committee on Human Research Protections October.

IRB-Investigator/ Research Coordinator Mtg. “CUMC’s New Progressive Policy For Adverse Event Reporting” April 13, 2004 George Gasparis Andrew Wit, Ph.D.

Columbia University IRB IRB 101 September 21, 2005 George Gasparis, Executive Director, CU IRB Asst. V.P. and Sr. Asst. Dean for Research Ethics.

CUMC IRB Investigator Meeting Status of the IRB January 18, 2005.

Karen Moe, PhD Director, Human Subjects Division Assistant Vice Provost for Research Revising the IRB Application A HSD Process Improvement Initiative.

Pharmaceutical Development and Review Process Rev. 10/21/2014 APGO Interaction with Industry: A Medical Student Guide.

Brookhaven Science Associates U.S. Department of Energy 1 Brookhaven National Laboratory Protocol Compliance Monitoring Darcy Mallon May 7, 2009.

Clinical Pharmacy’s Role in Research Trials Sheree Miller Pharm.D. Investigational Drug Service University of Washington Medical Center.

Unlocking the Mystery of General Information Reporting Research Compliance Administration Training Presentation Wednesday, June 6, 2007 Presenter:Heather.

IRBMED AND CHESAPEAKE IRB General Procedures for Ceding IRBMED Oversight Procedures Specific to Chesapeake IRB Medical School Institutional Review Board.

Update on the Enterprise Initiative: e-IRB and More Riyad Naser, MS, MBA Director of Research Information Systems Karen Blackwell, MS, CIP Director, Human.

Response to FDA Audit 483 MX-4501N : Nine Category 483 Citations Meetings Minutes: Votes for, against, abstention and reason not recorded;

03/07/2003Copyright  2003 Georgetown University1 Compliance Programs in Academic Medical Centers Kenneth L. Dretchen, PhD Director of Regulatory Affair.

Adverse Events and Unanticipated Problems Presented by: Karen Jeans, PhD, CCRN, CIP COACH Program Analyst.

Carine M. Lenders, M.D., M.S. Medical Director, NFL program Director, Pediatric Nutrition Support Services Research Staff, General Pediatrics Assistant.

1.02 Advanced Compliance Strategies for Academic Medical Centers Kenneth L. Dretchen and Shelia Zimmet Georgetown University Medical Center.

1 27 April 2004 CFS Division Day – New York hCue Product Demonstration Walter Garcia Business Analyst.

New IRB Guideline Changes and Converting to eIRB - Suggestions for Maintaining Compliance. Ramesh Ghodgaonkar, BPHARM, MSITS, MSB, MBA Betsy Johnson, BA.

Reporting Unanticipated Problems and Adverse Events: A Change in Policy Mary A. Banks RN, BS, BSN Director, BUMC IRB Wednesday, November 14, 2007.

Adverse Event Reporting.

Office of Research Oversight ORO Reporting Adverse Events in Research to ORO Paula Squire Waterman, MS, CIP Department of Veterans Affairs Office of Research.

MANAGING CONFLICTS OF INTEREST IN UM/JHS HUMAN SUBJECT RESEARCH 1.GENERAL PRINCIPALS AND PROCEDURES 2. REGULATIONS, POLICIES AND UM PROCESS Human Subjects.

RESCUE: ACRIN 4701 Protocol Development & Regulatory Compliance (PDRC) Josephine Schloesser, ACRIN Monitor Chris Steward, ACRIN QC Auditor.

Drug Submissions: Review Process Agnes V. Klein, MD Biologics and Genetic Therapies Directorate February, 2003 www/hc-sc.gc.ca/hpb-dgps/therapeut.

Research Auditing Presented by: Darlene Krueger, MBA RN CCRA Chief, GCP Auditing & Training VA Cooperative Studies Program Albuquerque, NM.

Role of the Oncology Research Team Carmen B. Jacobs, BS, RN,OCN, CCRP U.T.M.D. Anderson Cancer Center Houston, Texas U.S.A.

3 June 2010National Academies - BRDI1 Research Data and Information: Recent Developments and Continuing NIH Interests Jerry Sheehan Assistant Director.

Secretary’s Advisory Committee on Human Subjects Protections (SACHRP) Summary of Responses on: Advanced Notice of Proposed Rulemaking (ANPRM) on Holding.

Human Subjects Research Cynthia Edmonds Director, Office of Research Support Committees.

TERRENCE F. ACKERMAN, PH.D. PROFESSOR OF BIOETHICS CHAIR, UTHSC IRB.

Belinda Seto, Ph.D. Acting Deputy Director for Extramural Research National Institutes of Health Human Subjects Research Enhancements Awards Renaissance.

The NCI Central IRB Initiative Third Annual Medical Research Summit Washington, D.C. March 2003.

Development and Approval of Drugs and Devices EPI260 Lecture 6: Late Phase Clinical Trials April 28, 2011 Richard Chin, M.D.

Yadvindera (Bobby) Bains MD Director of Radiation Oncology, Laredo Medical Center Adjunct Associate Professor, Dept of Radiation Oncology, University of.

FDA Regulatory and Compliance Symposium

The NCI Central IRB Initiative Jacquelyn L. Goldberg, J.D. VA IRB Chair Training April 8, 2004.

CTMB Guidelines (Rev. October 2006) Section 5: Conducting the Quality Assurance Audit.

Office of Research Oversight 1 Office of Research and Development Local Accountability Meeting January 2009.

2012 State of the IRB Boston University Charles River Campus (CRC) Cynthia J. Monahan, MBA, CIP Director, Institutional Review Board.

Office of Human Research Protection Georgia Health Sciences University.

The TJU Human Research Protection Program (HRPP): Part I – Which Entities/Offices are Involved ? J. Bruce Smith, MD, CIP.

Building A Bridge from Central Administration to Departments, Centers and Institutes Mary E. Schmiedel, JD, CPCM Georgetown University Mary Glasscock Georgetown.

VA Central IRB K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs.

VA Central IRB K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs September.

VA Central IRB MOU Webinar K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs.

ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office.

Multi-site Research - Central/Single IRBs - Data sharing questions P. Pearl O’Rourke, MD Partners HealthCare October 26, 2015.

HRPP METRICS Cynthia Monahan, MBA, CIP IRB Director Boston University Charles River Campus IRB.

OHRP Update Michael A. Carome, M.D. Associate Director for Regulatory Affairs Office for Human Research Protections 3 rd Annual Medical Research Summit.

Introduction Review and proper registration of Human Gene Transfer protocols is very complex. A protocol goes through rigorous review by multiple Committees.

Introduction to the Human Research Protections Office (HRPO)

Overview: IRBshare  IRBchoice

The Information Professional’s Role in Product Safety

FDA’s IDE Decisions and Communications

Navigating eIRB and eIRB Submission Types

eResearch at Emory Phase I: eIRB

eResearch at Emory Phase I: eIRB

eResearch at Emory Phase I: eIRB

Human Gene Therapy Institutional Review Procedures

IRB Harmonization 2016 Review

Presentation transcript:

FDA: 3/21/05 Computerized Adverse Event Reporting (CAER) Office of Regulatory Affairs Georgetown University Medical Center Washington, DC Sorell L. Schwartz, PhD Professor Emeritus of Pharmacology Director, Division of Research Information and Assessment Kolaleh Eskandanian, MBA, PhD Program Manager, Division of Research Information and Assessment

FDA: 3/21/05 CAER Raison d’Etre Research subject safety and compliance with regulatory requirements o Expedited adverse event assessment and reporting Facilitation of both internal and external adverse event reporting o Most AE reporting system do not take into consideration the sheer volume of external reports o Most institutions are doing sponsored or cooperative group studies, whereby the processing of external reports becomes burdensome. Serving IRB’s pivotal role in reviewing adverse events o Ultimate decisions concerning safety and efficacy are done at the local IRB level Central repository of adverse events o Cross-trial analyses o Search for specific variables o Identification of trends o “Ad Hoc” and “Preformatted” reporting

FDA: 3/21/05 CAER Features Electronic submission of new and follow-up internal and external adverse event reports Creation of amendments Algorithmic-like assistance of causal relationship Validation of entries for completeness and consistency

FDA: 3/21/05 CAER Features (Cont’d) Trend and root cause analyses notifications Browser and operating system independency Cross-referencing among protocols Compliance with standards o MedDRA o Section 508 o HL7 messaging Compliant

FDA: 3/21/05

CAER – Status Beta testing began April 2003 Incrementally rolled out to GU and Non-GU departments, under the oversight of GU IRB and MedStar Research Institute - Georgetown University Joint Oncology Institutional Review Board November 1, 2004: Full rollout; paper- based AE report forms no longer accepted

FDA: 3/21/05 Snapshot From first use, April 2003 to 3/15/2005, the total number of CAER reports = 2612 o 304 (11.6%) of these were internal; 22 of these led to ICF revisions o 2308 (88.4%) were external events; 533 of these led to ICF revisions

FDA: 3/21/05 Snapshot Between 11/01/2004 to 3/15/2005 present, the total number of CAER reports = 777 o 97 (12.5%) of these were internal: 3 of these led to ICF revision o 680 (87.5%) were external events: 161 were filed as “expected” o 145 ICF revisions were required as a result of external AE reports