CTN Webinar: IRB and Regulatory Documentation.

Presented by Emily Dorer (University of Cincinnati, OV Node) and Ro Shauna Rothwell, PhD (EMMES Corporation).

Produced by the National Drug Abuse Treatment Clinical Trials Network's Clinical Coordinating Center, April 24, 2013.

This 1-hour session will focus on Institutional Review Board (IRB) requirements and oversight in the conduct of research trials, particularly in the CTN, as well as the requirements for regulatory document management at the site, Node compliance, and regulatory document obligations to the sponsor.

Objectives include:

  • Identifying critical aspects of IRB oversight and compliance
  • Determining appropriate regulatory documentation practices
  • Explaining roles and responsibilities involved in reporting progress to regulatory bodies.

Target Audience: Everyone is welcome! You do not have to be a CTN member to register for this webinar.

Presented by Emily Dorer, University of Cincinnati, OV Node, and Ro Shauna Rothwell, PhD, Wayne State University.

(Webinar, Video, English, 2013)

Keywords: Patient protections | Research design | Training | Clinical Coordinating Center webinar

Document No: 983

Submitted by CTN Dissemination Librarians, 5/12/2013.

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 5/2013 --