'Irb' presentation slideshows

Investigator Responsibilities for Research

Investigator Responsibilities for Research. Jan Zolkower, MSHL, CIP, CCRP January 13, 2012. Agenda. Review Investigator Responsibilities Discuss recent FDA Warning letters and OHRP Determination letters Review of Advanced Notice of Proposed Rulemaking (ANPRM) Q & A. PI Responsibilities.

701 views • 57 slides

787 views • 47 slides

Kimberly Summers, PharmD Deputy ACOS for Research South Texas Veterans Health Care System

VA Research: IRB and R&D Approval Process From Initial Submission, Through the Informed Consent Process and Continuing Review, To Inactivation. Kimberly Summers, PharmD Deputy ACOS for Research South Texas Veterans Health Care System Research & Development Service. Overview.

619 views • 46 slides

man Research Protections and Quality Assurance

man Research Protections and Quality Assurance Institutional Review Board Orientation & IRB Submission Process Kevin Nellis, MS, CIP Executive Director, Human Research Protections and Quality Assurance. Institutional Review Board (IRB ) & Privacy Board.

456 views • 27 slides

Differentiating Roles of IRBs vs. Institutions IRB and R&D Committee Workshop August 20-21, 2019

Differentiating Roles of IRBs vs. Institutions IRB and R&D Committee Workshop August 20-21, 2019. Objectives. Identify three major areas where IRBs or Institutions have difficulty with differentiating the roles of each in the review and approval of human subjects research.

474 views • 25 slides

393 views • 25 slides

Andy Bertolatus MD 2/22/10

Andy Bertolatus MD 2/22/10. Preparing an IRB Application. Learning Objectives. Know when an IRB application needs to be submitted Understand the workflow of IRB applications through the Human Subjects Office (HSO) Understand criteria for IRB approval. Institutional Review Boards (IRBs).

317 views • 25 slides

Working with Human Subjects in Research

296 views • 19 slides

Current IRB at DMACC

Current IRB at DMACC. September 2018. General Types of Human Research. RESEARCH that involves direct interaction with individuals (e.g., in person, or via mail, email, web survey, or telephone), or data from human subjects for which the researchers will have access to identifiers.

325 views • 18 slides

CTSA IRB Pilot Study Next Steps

CTSA IRB Pilot Study Next Steps. Marc K. Drezner , M.D. Senior Associate Dean School of Medicine and Public Health University of Wisconsin Professor of Medicine. IRB Review. Project Awareness. First Enrollment. Contract.

278 views • 17 slides

Institutional Review Board

Institutional Review Board. “IRB Snapshot”. IRB Team. Annabelle Casas—Institutional Coordinator for Research Review (extension 7939) Irene Holguin—Grants and Contracts Specialist (extension 8683) Cecy DeSantiago—Administrative Assistant (extension 5401) IRB Administrator—vacant

289 views • 13 slides

DHMH Institutional Review Board

DHMH Institutional Review Board. Research, Respect and Responsibility. DHMH IRB Staff. Gay Hutchen, IRB Administrator Chante Tindal, IRB Coordinator Pamela Owens, Esq., Chief, Corporate Compliance Officer. DHMH.

272 views • 12 slides

Policy on Prompt Reporting

Policy on Prompt Reporting. Office of Human Subjects Research May 17, 2019. Purpose of Policy. Policy updated December 2018

245 views • 11 slides

IRB Member Conflict of Interest

IRB Member Conflict of Interest. Presentation for IRB Members. Regulations. DHHS and FDA regulations [45CFR 46.107(e) & 21CFR 56.107(e)] prohibit members from participating in IRB reviews if they have a conflict of interest.

158 views • 8 slides

Investigator Meeting January 2010

Investigator Meeting January 2010. Protocol Review and Refresher. Study close out. Supplies Data EFIC Regulatory. Study close out - supplies. Destroy Remaining Study Drug Remove all study boxes from field Waste and retire study drug in WebDCU Remaining Supplies

224 views • 7 slides

Management (Core 7) Update

Management (Core 7) Update. NA-MIC AHM Sanjay Manandhar & Stephen Wong. Pre-grant Preparation. Budgeting and re-budgeting and liasing with NIH and 14 partner Institutions Collection of IRB documents Collection of NIH required doc such as Other Support docs Web-site preparation

373 views • 6 slides

EA Project Types

253 views • 4 slides

August 21, 2019

IRB Breakout Session #1: What are the Critical Functions and Challenges of Coordinators and Committees?. August 21, 2019. Questions. What are the top three critical functions of an IRB coordinator?

168 views • 4 slides

DERC shares the workload with NUS-IRB

DERC shares the workload with NUS-IRB. Undergraduate research projects dealing with human subjects (e.g., surveys, experiments, focus groups, interviews, ethnography) Honours thesis If minority groups are involved, applications should be submitted to NUS-IRB

138 views • 1 slides

Lessons Learned: The IRB and Contracts Process

146 views • 1 slides