For The Consortium

Regulatory Knowledge Key Function Committee

Description:

The CTSA Regulatory Knowledge Key Function Committee will promote the protection of human subjects and facilitate communicating shared regulatory compliance issues and improvements. Clinical research regulation issues addressed may include the provision of integrated training, services, or tools for protocol and informed consent authoring and translation, adverse event reporting, safety and regulatory management and compliance, etc. CTSAs can disseminate best practices that reduce or remove institutional impediments to clinical and translational research which would enhance inter-institutional collaborations. Regulatory support provided through a CTSA should assist investigators in their regulatory process and documentation requirements. The CTSA Regulatory Knowledge Key Function Committee will also ensure that collaborative clinical and translational research activities are facilitated, whether by procedures and best practices, in developing the Regulatory Support interactions with the IRB and compliance office without loss of participant protections.

Regulatory Knowledge Groups:
Alternative IRB Model Pilots
Clinical Trial/Study Registration Tracking
CMS Regulations Impact
Research Coordinator
Research Subject Advocacy
IND/IDE Support
Monitoring/DSMB Affinity Group
Regulatory Core Competency Training Taskforce
Recruitment and Retention Taskforce
Clinical Research Management System Information Sharing

Regulatory Knowledge Participants:
Co-Chair(s) Rhonda G. Kost (Rockefeller)
Kathryn G. Schuff (OHSU)
NIH Coordinator(s) Jody G. Sachs (NCRR)
PI Liaison(s) Robert Califf (Duke)
Elan Czeisler (NYU)
Daniel E. Ford (Johns Hopkins)
Project Manager(s) Harris, Ashley
Participation Click to view
Next Meetings October 21, 2011
1:00 PM - 2:00 PM

November 18, 2011
1:00 PM - 2:00 PM

December 16, 2011
1:00 PM - 2:00 PM

Previous Meetings
(2011)
September 23, 2011
August 26, 2011
July 22, 2011
May 20, 2011
March 25, 2011
February 25, 2011
January 12, 2011
Previous Meetings
(2010)
December 17, 2010
November 19, 2010
October 22, 2010
October 13, 2010
September 24, 2010
September 15, 2010
August 27, 2010
July 23, 2010
June 4, 2010
April 30, 2010
March 26, 2010
February 26, 2010
January 22, 2010
Previous Meetings
(2009)
December 18, 2009
November 20, 2009
October 23, 2009
September 11, 2009
July 24, 2009
May 28, 2009
April 24, 2009
March 27, 2009
February 27, 2009
January 23, 2009
Previous Meetings
(2008)
December 5, 2008
October 24, 2008
September 26, 2008
August 22, 2008
July 25, 2008
May 23, 2008
April 25, 2008
February 22, 2008
January 25, 2008
Previous Meetings
(2007)
December 21, 2007
September 12, 2007