Projects

Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

CTTI Project: Single IRB

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Webinar Presenters

  • Daniel Nelson, Director, Office of Human Research Ethics, University of North Carolina at Chapel Hill
  • Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

To share experiences from two research institutions about implementation of a central IRB model for multi-center clinical trials

Webinar Agenda

  1. Results from a randomized, controlled trial of central versus local IRB review
  2. The institutional policy resulting from study results and a summary of conclusions that can be applied more broadly
  3. The continuing role of the institution in research compliance
  4. Examples from a research institution that serves as a central IRB and relies on commercial, academic, and federal external IRBs for multi-center clinical trials
  5. Questions and Discussion

Presenting CTTI Recommendations: Informed Consent

CTTI Project: Informed Conent

Webinar Presenters:

  • Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
  • Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

Team members from CTTI’s Informed Consent Project unveiled the official recommendations resulting from this project. These recommendations propose a new model for the informed consent process that places the focus back where it should be: on the participant.

Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials

CTTI Project: Patient Group Engagement

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Webinar Presenters

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

Team members from CTTI’s Patient Groups & Clinical Trials project presented the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.

Quality by Design Project: Recommendations and Toolkit

CTTI Project: Quality by Design

Webinar Presenters:

  • Ann Meeker-O'Connell, Head, Risk Management and External Engagement, Johnson & Johnson BioResearch Quality & Compliance
  • Coleen Glessner, MBA, Quality Expert
  • Martin Landray, Clinical Trials Service Unit & Epidemiological Studies Unit, University of Oxford

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

The Quality by Design (QbD) project team presented the QbD recommendations and an introduction to the QbD Toolkit, released June 15, 2015. This web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts.

Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment

CTTI Project: Electronic Healthcare Data

Webinar Presenters:

  • Richard Platt, MD, MS, of Mini-Sentinel
  • Patrick Archdeacon, MD of the FDA

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective:

Summarize the work generated by CTTI’s Uses of Electronic Data Project and the resulting, recently released report, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database