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White Papers

Interventional Clinical Trial or Registry Study? Writing Protocols that Demonstrate the Difference

Authors:

Lindsay A. Abraham, JD, CIP
Regulatory Lead, IRB Chairs
Western IRB, a WIRB-Copernicus Group Company

Jeffrey A. Cooper, MD, MMM
Vice President, Process & Strategic Improvement
WIRB-Copernicus Group

By |January 24th, 2017|Insights, White Papers|

The 21st Century Cures Act: Implications for Human Subject Protections

Authors:

Daniel Borasky, MPH, CIP
Vice President of Quality Management
Copernicus Group IRB, a WIRB-Copernicus Group Company

David Forster JD, MA, CIP
Chief Compliance Officer
WIRB-Copernicus Group

Lindsay McNair, MD, MPH, MSB
Chief Medical Officer
WIRB-Copernicus Group

By |December 14th, 2016|Insights, White Papers|

Infectious Disease Challenge Studies: Ethical Issues in Causing Disease for Medical Knowledge

Authors:

Daniel Kavanagh, PhD
Senior Director, Biosafety & Gene Therapy
WIRB-Copernicus Group

Currien MacDonald, MD, CIP
Board Chair & Medical Lead
Western IRB, a WIRB-Copernicus Group Company

Lindsay McNair, MD, MPH, MSB
Chief Medical Officer
WIRB-Copernicus Group

By |December 2nd, 2016|Insights, White Papers|

Reducing Study Team and Site Burden through an Integrated eClinical Platform Solution

Author:

Lance Converse
Chief Innovation Officer
WIRB-Copernicus Group

By |November 21st, 2016|Insights, White Papers|

Towards Total Quality Management in Human Research Protection Programs: IRB Administrative and Reviewer Activities

Author:

Andrew Olmsted, MBA
Executive Vice President
IRBNet, a WIRB-Copernicus Group Company

By |September 27th, 2016|Insights, White Papers|

Informed Consent Progress Toward an Improved Process

Author:

David Borasky, MPH, CIP
Vice President of Quality Management
Copernicus Group IRB, A Division of the WIRB-Copernicus Group

By |September 7th, 2016|Insights, White Papers|

Minimizing Impact of New NIH Recombinant DNA Advisory Committee Review Process on Early Phase Human Gene Therapy Studies

Authors:

David W. Emery, PhD
Director, IBC Services
WCG Biosafety, A Division of the WIRB-Copernicus Group

Joan M. Robbins, PhD
Senior Vice President, Biosafety & Gene Therapy
WCG Biosafety, A Division of the WIRB-Copernicus Group

By |July 29th, 2016|Insights, White Papers|

Managing Conflicts of Interest: Why an Independent IRB Should be Part of an Institution’s Policy

Author:

Stuart Horowitz, PhD, MBA
President, Institutions & Institutional Services
WIRB-Copernicus Group

By |June 30th, 2016|Insights, White Papers|

Innovation in Investigator Site Contracting

Author:

Steven Jones, JD
General Counsel & Corporate Secretary
Clintrax Global, A WIRB-Copernicus Group Company

By |June 30th, 2016|Insights, White Papers|

Glossary of Commonly Used Terms in Human Subject Protection

This Glossary of Commonly Used Terms in Human Subject Protection was compiled from various federal and international sources to bring together all of the terms necessary for understanding the concepts in human subject protection (HSP).

As the leading Clinical Services Organization (CSO), we at WCG understand the importance not only of HSP, but also of […]

By |June 30th, 2016|Insights, White Papers|