IRB Inspections

Oct 12, 2012

530 likes | 763 Views

2. Objectives. Inspections ProgramOHRPFDATips for PreparationCommon DeficiencyBehavioral Guidelines. 3. Jurisdiction. OHRP45 CFR 46OHRP approved assuranceFDA21 CFR 5621 CFR 50. 4. Inspections Program. OHRPFor cause site visitNot for cause site visitFDARoutine surveillance inspectionD

Share Presentation

Embed Code

Link

tess

Download Presentation

IRB Inspections

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

FDA’s BIMO Inspection Program and IRB Inspections

FDA’s BIMO Inspection Program and IRB Inspections. VA IRB Chairs Meeting August 2012 Janet Donnelly RAC, CIP Office of Good Clinical Practice Office of the Commissioner Food and Drug Administration. Disclaimer.

811 views • 47 slides

Inspections

Inspections. Malaria product manufacturers Active Pharmaceutical Ingredients Finished Products. Policy and objectives. Each manufacturer should be inspected by the organization to assess compliance with Good Manufacturing Practices.

472 views • 16 slides

IRB Review

IRB Review. Mechanics: Looking under the hood IRB Administrators 2012 PRIDE Lucindia Shouse, MS, CIP. May 31, 2012. Road Map. Question-and-Answer Session Traveling to and fro (basic, beyond and in between) Exploring the IRB Meeting Agenda Quorum Approval Criteria Minutes

860 views • 70 slides

IRB Workshops

IRB Workshops. Initially will be given in three parts 1. Human subject research ethics History of research ethics History of unethical research 2. Regulatory IRB responsibilities Investigator responsibilities Informed consent requirements 3. Logistics Office contacts

544 views • 36 slides

FDA’s BIMO Inspection Program and IRB Inspections

916 views • 47 slides

IRB Insights

IRB Insights. UTHSC IRB irb@uthsc.edu 448-4824. Categories. Review Process Exempt Expedited Full Board Forms Initial Application Form 2 – Change Request & Amendment Form 3 – Continuation & Renewal Form 4 – Unanticipated & Adverse Events and Protocol Deviations

624 views • 49 slides

IRB Review Process at IRB-HSBS

IRB Review Process at IRB-HSBS. IRB Health Sciences & Behavioral Sciences University of Michigan 2009-2010. Goals of this Audiocast. Describe possible IRB review paths Outline the general process of IRB review at IRB-HSBS Implications of timing of IRB submissions

357 views • 11 slides

IRB Submission

UC DAVIS OFFICE OF RESEARCH. IRB Submission . Miles McFann IRB Administration Outreach, Training, and Education . Smallpox Vaccination . Objectives. Explain the history of Institutional Review Boards (IRBs) Define “Research” and “Minimal Risk”

693 views • 40 slides

IRB

IRB. The purpose of IRB is to ensure the rights of research subjects are protected In accordance with the ethical standards of the U.S. Department of Health and Human Services, all research involving human subjects requires approval by the IRB prior to the start of the research project.

295 views • 9 slides

IRB Training

IRB Training. What is irb ?. Work with a partner to answer these questions… 1. What does IRB stand for? 2. Why is the IRB important? 3. What are the steps to have your research project certified by the IRB?. What does irb stand for?. Institutional Review Board. Why is the IRB important?.

356 views • 14 slides

Inspections

Inspections. Inspections should : Motivate each cadet to “wear my uniform properly” Raise the standards Evaluate competence Judge for Cadet of the Month/Year awards, if appropriate. Inspections should not : Grill cadets Haze cadets by public criticism or humiliation. Purpose.

444 views • 13 slides

IRB Workshop I: IRB Process

IRB Workshop I: IRB Process. Carolyn Murdaugh, PhD, RN, FAAN Alice Pasvogel, PhD, RN Office of Nursing Research. Keep in mind: Ongoing changes. IRB changes are constant Forms Guidelines Staff. How do I begin the process?. Defend research proposal or scholarly inquiry project

286 views • 13 slides

IRB Metrics

IRB Metrics. Tony Perez Chief Health Sciences Counsel University of California, San Diego (formerly Director, IRB Administration University of California, Davis). IRB Metrics. Measure IRB Approval Process Establish Common Milestones Define Milestones When has milestone been achieved?

363 views • 20 slides

IRB Accreditation and Local IRB Operations

IRB Accreditation and Local IRB Operations. Libbie Stephenson, UCLA Thomas Lindsay, UMN Jacob Carlson, Purdue IASSIST Conference, May 2009 Tampere, Finland. Privacy.

210 views • 11 slides

IRB Presentation

Institutional Review of Research Involving Human Participants. IRB Presentation. University of Central Florida Office of Research & Commercialization 407-823-2901 or fax 407-823-3299 www.research.ucf.edu/Compliance/irb.html. University of Central Florida Institutional Review Board Overview.

445 views • 32 slides

Click IRB

Click IRB. Module 2 – Click IRB and CITI Training. Objectives. In this module you will learn: What is the required training? How CITI training is integrated in Click IRB. Training Requirements.

181 views • 7 slides

IRB Submission

UC DAVIS OFFICE OF RESEARCH. IRB Submission. Miles McFann IRB Administration Outreach, Training, and Education. Smallpox Vaccination. Objectives. Explain the history of Institutional Review Boards (IRBs) Define “Research” and “Minimal Risk”

472 views • 40 slides

IRB 7.2 IRB Member Training

IRB 7.2 IRB Member Training. Presented by: Joey Casanova, CIP Associate Director for Educational Initiatives Human Subject Research Office. Locating Checklists. Several worksheets and checklists are provided in the system to guide your review process and document your decisions.

594 views • 38 slides

Inspections

Inspections. Instructor Information. Room 2105 (703) 805-3895 DSN 655-3895. Basic Ground Rules. Please ask questions relevant to the topic of Inspections. Please avoid sidebar discussions during the instruction.

798 views • 73 slides

More Related