For The Consortium

Clinical Research Management Key Function Committee

Description:

The mission of the Clinical Research Management Key Function Committee is to review and comment on protocol processing issues from initial protocol development up to the point of subject enrollment on clinical trials. Some of these include: designing, drafting, and editing of protocols and informed consent documents; review and revision by supervisory and regulatory bodies; contracting and other intellectual property (IP) issues; compliance with regulations and policies including federal, state, and local governments, and all relevant regulatory bodies and agencies; budgeting and funding considerations; administrative, facilities, and technical support issues; human resource protocol processing support mechanisms such as systems engineers, teams, mentors, managers, concierges, and consultants; and technical support/electronic protocol management. This committee will address methods of improving clinical research management at CTSA institutions and will explore methods of making the Consortium effective in this regard. Potential methods include systematic investigations, use of metrics, public presentations, and publication of its findings.

Accomplishments:

Save the Date - The 3rd Annual Clinical Research Management Workshop
June 21-22, 2010
Bethesda North Marriott Hotel & Conference Center
Bethesda, MD

The Clinical Management Workshop serves as a dynamic venue for CTSAs and representatives from private industry, the National Institutes of Health, the Food and Drug Administration, and private research organizations to come together to discuss challenges and develop strategies that will improve clinical research management processes.  The use of metrics to monitor process performance in IRB, grants and contract management, and budget development; along with recruitment and retention strategies, are among the many topics to be discussed at the Workshop. Interested individuals from all sectors are welcome to attend the general sessions.  Special breakout sections have been planned to emphasize specific interests of CTSA site specialists in contracts, IRB issues, electronic IRB software selection and implementation, and recruitment and retention.  A face-to-face meeting of the Champions of Change for the CTSA Consortium will provide participants with specific tasks to help improve clinical research management at their sites.

For more information and to register, please visit the conference website: www.ycci.yale.edu/conference

Contact(s):
Kelly Burton: kelly.burton@yale.edu; (203) 785-2519
Frederic De Pourcq: frederic.depourcq@yale.edu; (203) 785-4027
Yale Center for Clinical Investigation: (203) 785-3482

Clinical Research Management Groups:
Contracts
Workshop Planning

Clinical Research Management Participants:
Co-Chair(s) Jeffrey Silverstein (Mount Sinai)
Jane E Strasser (Cincinnati)
NIH Coordinator(s) Fred Ognibene (NCC)
Daniel Rosenblum (NCRR)
Project Manager(s) Batista, Kevin
Participation Click to view
Next Meetings September 16, 2010
2:00 PM – 3:00 PM

October 21, 2010
2:00 PM – 3:00 PM

November 18, 2010
2:00 PM – 3:00 PM

December 16, 2010
2:00 PM – 3:00 PM

January 20, 2011
2:00 PM – 3:00 PM

February 17, 2011
2:00 PM – 3:00 PM

March 17, 2011
2:00 PM – 3:00 PM

April 21, 2011
2:00 PM – 3:00 PM

May 19, 2011
2:00 PM – 3:00 PM

June 16, 2011
2:00 PM – 3:00 PM

August 10, 2011
1:00 PM – 2:00 PM

Previous Workshops

June 22, 2010

June 21, 2010

June 23, 2009

June 22, 2009

June 24, 2008

June 23, 2008

Previous Meetings
(2010)
September 1, 2010
August 19, 2010
July 9, 2010
June 11, 2010
Previous Meetings
(2009)
December 11, 2009
November 13, 2009
September 11, 2009
July 10, 2009
February 13, 2009
January 9, 2009
Previous Meetings
(2008)
December 16, 2008
December 12, 2008
October 17, 2008
June 9, 2008
May 12, 2008
April 14, 2008
March 12, 2008
February 20, 2008
January 24, 2008