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 |
| Regulatory Core Competency Training Taskforce |
| Recruitment and Retention Taskforce |
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) |
| Project Manager(s) | Lee, Helen |
| Participation | Click to view |
| Next Meetings |
September 15, 2010 10:30 AM – 11:30 AM October 22, 2010 1:00 PM – 2:00 PM November 19, 2010 1:00 PM – 2:00 PM December 17, 2010 1:00 PM – 2:00 PM |
| Previous Meetings (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 |
| Previous Meetings (1987) |
July 23, 1987
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