WCG Market Intelligence & Insights
FALLS CHURCH, Va. (PRWEB) March 15, 2019
The Common Rule
**Changes to Come**
A CenterWatch Webinar
Friday, March 29, 2019, 1:30 p.m. - 3:00 p.m. EDT
https://store.centerwatch.com/p-591-the-common-rule-changes-to-come.aspx
What’s changed with the Common Rule and why does one need to know about it?
Kristin J. Craun, MPH, CIP, Senior Director of the Institutional Review Board at the University of Southern California, will help clarify key aspects of the revised Common Rule and discuss approaches for educating research teams and ensuring compliance. Over the course of 90 minutes she’ll help attendees understand how:
- The new exempt categories may reduce obligations in human subject protection
- The new required elements of consent change the standards for informing patients and obtaining consent — increasing subject protection responsibilities
- The use of continuing review policies apply to minimal risk research, and its effect on daily responsibilities in managing clinical trials
- How one academic medical center is implementing the new Common Rule standards and developing best practices in several keys areas — including subject protection policy and practice and modifications to its electronic submission system
- The new Common Rule requirement allows flexibility in some clinical trial areas — and the key factors in determining when and how this flexibility can be utilized
After attending this webinar one will know how the revisions of the Common Rule parallel flexibility efforts for unregulated research and identify the key challenges when implementing different sets of regulations.
Meet Your Presenter:
Kristin J. Craun, MPH, CIP is the Senior Director of the Institutional Review Board at the University of Southern California. She received her B.A. from Boston University and her MPH from the University of California Los Angeles. Kristin is completing her Doctorate in Higher Education Leadership at the University of Southern California. Kristin is a specialist on vulnerable populations in social and behavioral studies. She is a faculty member of Public Responsibility in Medicine and Research (PRIM&R) and the Association for Accreditation of Human Research Protection Programs (AAHRPP). She is a counsel member and site reviewer for AAHRPP and also the recipient of the 2016 Distinguished Site Visitor Award for AAHRPP.
Who Will Benefit:
- Clinical Quality Assurance Professionals
- Clinical Operations Professionals
- Data Management Professionals
- Clinical Trial Electronic Systems Developers
- Clinical Trial Statisticians and Statistical Programmers
- Clinical Investigators and Clinical Investigator Site Staff
- Regulators- GCP inspectors
- Regulators- Reviewers/Assessors of Clinical Trial Data
Webinar Details:
The Common Rule
**Changes to Come**
A CenterWatch Webinar
Friday, March 29, 2019, 1:30 p.m. - 3:00 p.m. EDT
https://store.centerwatch.com/p-591-the-common-rule-changes-to-come.aspx
Tuition:
$287 per site
Easy Ways to Register:
Online: https://store.centerwatch.com/p-591-the-common-rule-changes-to-come.aspx
By phone: 617-948-5100 or 866-219-3440
About CenterWatch:
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.