Clinical Research Management Key Function Committee

As part of efforts by the new NCATS CTSA Steering Committee to emphasize focused project activity and streamline the consortium, the CTSA committees were closed effective February 17, 2014. All information related to those committees and their operations has been archived on the respective committee pages. Please direct any committee-related inquiries to info@ctsac4.org.

The mission of the Clinical Research Management (CRM) Key Function Committee is to foster enhancements in clinical research development and conduct in order to improve efficiency, reduce cost, and support research participant safety. 

Major areas of focus include:

  • Protocol development and associated processes
  • Study feasibility assessment, including funding, resourcing, and operational feasibility
  • Regulatory reviews including IRB review and other oversight entities
  • Study contract processes and standards
  • Study recruitment and retention
  • Study data management: tools, processes, and quality standards
  • Approaches to study oversight

There are no committee announcements at this time.

Goals and Objectives

  • Define processes to be used in mapping activities required for study-start up. (Process Excellence Group)
  • Develop pilot and definitive study for cross-Consortium improvement of clinical research management
    • Process maps for ten sites (UCSF, UC Irvine, UCSD, UCLA, UC Davis, U Cincinnati, OSU, CWU, UW, and Mt. Sinai (Contracts, IRB, MAM, and CRM
    • Study for improvement at the ten sites using planned implementation of changes based on Contracts and IRB studies, process maps, and advice from PEG, BERD. Metrics include  IRB approva' time, budget/contract negotiation/approval, time to 1st subject enrolled, time to study closed.
    • Recruitment and Retention cross-CSA study with tracking plan, metrics of success, and registry of tracking in central database. (Regulatory Knowledge – or part of combined RK and CRM)
  • Hold Workshop to disseminate information, include all CTSA sites in evaluation of pilot and plan for comprehensive study open to all sites. (CRM with RK and CSC)

Leadership

Co-Chair(s)
Jeffrey Silverstein (Mount Sinai)
Rebecca Jackson (Ohio State)

NIH Coordinator(s)

PI Liaison(s)
C. Bill William Balke (UCSF)
Curtis L. Lowery (Arkansas)

Subgroups

Clinical Research Management - IRB Study Group
Clinical Research Management - Contracts
Clinical Research Management - Metrics, Analysis, and Mapping Group
Clinical Research Management - NIH IC-CTSA CRM Collaboration Group
Clinical Research Management - Process Excellence Group
Clinical Research Management - Process Excellence Group - Teachers/Communicators Subgroup
Clinical Research Management - Workshop Planning

Annual Reports

Oct 23, 2012

Related Links

6th Annual CRM Workshop

Meeting Frequency

The Clinical Research Management KFC meets the 3rd Thursday of every other month from 2-3 p.m. EDT via web conference.

Aburto, Monica (USC)
Lilli, Kathy (Iowa)
Alfano, Sandra (Yale)
Linke, Michael (Cincinnati)
Allen, David (VCU)
Lowery, Curtis (Arkansas)
Allen, Pamila (Denver)
Lynch, Kristin (U Texas Medical Branch at Galveston)
Almandoz, Jaime* (U Texas Southwestern at Dallas)
Lyons, Susan (Birmingham)
Altemus, Margaret* (Cornell)
Marnocha, Rebecca* (UW-Madison)
Amey, Mike (Johns Hopkins)
Martell, Bethany* (Chicago)
Andersen, Burton (Illinois)
Mascette, Alice (NHLBI)
Aufderheide, Tom (MCWisc)
Mathew, Ajoy (CNMC)
Autry, Susan* (USC)
Mayo, Matthew (Kansas)
Ballard, Amy* (Arkansas)
McClain, Don* (Utah)
Barton-Baxter, Marietta (Kentucky)
McCloskey, Donna Jo (NINR)
Beck, James (UNC)
McFall, Courtney (UCSF)
Becker, Laura (MCWisc)
Meagher, Emma (UPenn)
Berg, Cathy ()
Melnyk, Halia (NYU)
Bigby, Barbara (Scripps)
Miller, Megan (Case Western)
Blackman, Marc* (Georgetown)
Milner, Robert (UMMS)
Breland, Carol (UNC)
Mitchell, Peggy (Northwestern)
Bremseth, David (UMN)
Moen, Rebbecca (Duke)
Brillon, David (Cornell)
Morneault, Mandy (UWashington)
Briones, Marisa (UCLA)
Morris, Kathryn (Arkansas)
Bronson, Sarah (PSU)
Mulnard, Ruth* (UC Irvine)
Budinger, Susan (Duke)
Neale, Richard* (Scripps)
Burge, Mark* (UNMHSC)
Nunnally, Beth (UMN)
Buse, John* (UNC)
O'Donoghue, Kelley* (Rochester)
Carpenter, Arthur (VCU)
Odeh-Ramadian, Rudi (Columbia)
Carrithers, Judith (Johns Hopkins)
Offenbacher, Steven (UNC)
Carroll, Liz (Mount Sinai)
Ognibene, Fred (NCC)
Castro, Lauren (Illinois)
Osanjo, Maureen (U Texas Southwestern at Dallas)
Chambers, Henry* (UCSF)
Page, Suzanne (Miami)
Chambers, Christina (UC San Diego)
Para, Michael (Ohio State)
Chapman, Arlene* (Emory)
Parker, Tim (Birmingham)
Chen, Liz (UCLA)
Peden, David (UNC)
Chou, Gloria (U Michigan)
Phelps, Mary (U Michigan)
Chowayou, Laurie (UWashington)
Pockros, Paul (Scripps)
Clements, Renee (Birmingham)
Podraza, Lynn (Illinois)
Cocco, Jennifer (Mount Sinai)
Pogash, William (PSU)
Cola, Philip* (Case Western)
Portilla, Lili (NCATS)
Collier, Elaine (NCATS)
Powell, Kathleen* (Birmingham)
Constantitne, Corinne (Cornell)
Rahbe, Sandra (Illinois)
Coulter, Amanda (U Michigan)
Ramsay, Douglas (UWashington)
Crow Adams, Mallary (Denver)
Ramsey-Goldman, Rosalind (Northwestern)
D'Agostino, Toni* (U Texas Medical Branch at Galveston)
Rhea, Arianne (U Texas Southwestern at Dallas)
De Pourcq, Frederic (Yale)
Rice, Linda (Kentucky)
Denmark, Signe (South Carolina)
Rifkind, Adam (UPenn)
Denton, Jo (Kansas)
Ripley, Elizabeth (BETSY)* (VCU)
Diercks, Deborah* (UC Davis)
Roache, John (U Texas at San Antonio)
Do, Chi (UWashington)
Rodriguez, Jose (VCU)
Drezner, Marc (UW-Madison)
Roman, Noreen (Case Western)
Dunn, Keren (UCLA)
Rose, Susan (USC)
Economy, Jennifer (VCU)
Rosenblum, Daniel (NCATS)
Elayi, Elodie* (Kentucky)
Rosenthal, Ann (MCWisc)
Erikson, John (U Texas at San Antonio)
Roth, Mary-Tara (Boston U)
Erzurum, Serpil (Case Western)
Rubinstein, Eric (Rochester)
Faghihi, Sarah (Indiana)
Sacksteder, Paulette (UW-Madison)
Falconer, Seanne (Harvard)
Saitz, Richard* (Boston U)
Fann, Yang (NINDS)
Sak, Rachael (UCSF)
Finerty, Ed (UNC)
Salberg, Libby* (Vanderbilt)
Fischl, Margaret (Miami)
Salusky, Isidro (UCLA)
Fleming, Lisa (U Texas Southwestern at Dallas)
samali, melahat (Tufts)
Fluharty, Laura (UPenn)
Sampson, Royce* (South Carolina)
Flume, Patrick (South Carolina)
Santini-Zakin, Dorothy (U Texas Medical Branch at Galveston)
Ford, Daniel* (Johns Hopkins)
Schacker, Tim* (UMN)
Forney, Leila (South Carolina)
Schaefer, Jennifer (PSU)
Franklin, Caryn ()
Schmelz, Joseph* (U Texas at San Antonio)
Gabriel, Davera (UC Davis)
Sheard, Judy (Scripps)
Galgocy, Elizabeth (PSU)
Shore, Eileen (Einstein)
Gentilin, Stephanie (South Carolina)
Silverstein, Jeffrey (Mount Sinai)
Gerrity, Lauretta (Birmingham)
Simari, Robert* (Mayo)
Gipson, Debbie (U Michigan)
Skelton, Stephen (South Carolina)
Glenn, Lane (South Carolina)
Snyder, Denise (Duke)
Gordon, Patricia (PSU)
Speicher, Lisa* (UPenn)
Green, Nancy* (Columbia)
Spiegel, Diana* (Indiana)
Grenald, Dilcia (Cornell)
Sridhar, Sujatha* (U Texas at Houston)
Grieb, Teri (U Michigan)
Stacy, Mark (Duke)
Gunter, Molly* (Kansas)
Stapleton, Ann (UWashington)
Gutierrez, Raquel (UCLA)
Staudacher, Tracy* (MCWisc)
Hafer, Nathaniel (UMMS)
Stedman, Lynn (Birmingham)
Hagemann, Jennifer (USC)
Steinbugler, Kathryn (UPenn)
Hammack, Barbara* (Denver)
Stephens, Eunice (UCSF)
Harris-Hooker, Sandra (Emory)
Stiles, Deborah (Columbia)
Hayward, Anthony (Other Organizations)
Strasser, Jane* (Cincinnati)
Helm, Shirley (VCU)
Stroud, Mary (Vanderbilt)
Hilliard, Kate (Case Western)
Summar, Marshall* (CNMC)
Hirzallah, Muhanad (Mayo)
Tamborlane, William (Yale)
Hoffman, Anthe (Florida)
Taras, Howard (UC San Diego)
Holahan, James (Cornell)
Taylor, Connie (Stanford)
Holbein, Blair (U Texas Southwestern at Dallas)
Thomson, Blythe* (UWashington)
Hoop, Jinger (Illinois)
Tolentino, Jerlyn (UCLA)
Hormann, Barbra (Cornell)
Toussant, Kim* (Ohio State)
Hutchinson, Raymond (U Michigan)
Trujillo, Danielle (UNMHSC)
Jackson, Rebecca (Ohio State)
Tyson, Clare (South Carolina)
Jenkins, Rebecca (PSU)
Uscinski, Kathleen (Yale)
Johnsen, Linda (UNC)
Usry, Lou (VCU)
Johnson, Lisa (UMN)
verne, arlene (UCLA)
Johnson, Holly (Charles Drew University)
Walsh, Tom (Florida)
Johnson, Tesheia* (Yale)
Wang, Christina* (UCLA)
Johnson, Meg (UMMS)
Weatherwax, Kevin (U Michigan)
Jonklaas, Jacqueline (Georgetown)
West, Robin (Einstein)
Kain, Jeannie (U Michigan)
Wiggins, Melanie (VCU)
Katz, Barrett* (Einstein)
Wilkinson, Kathleen (U Texas Southwestern at Dallas)
Kiani, Pamela (U Texas Medical Branch at Galveston)
Williams, Maija* (Rockefeller)
Kirby, Aaron* (Tufts)
Williams-Bayne, Helen (UCLA)
Kiriakis, Jim (UCSF)
Winkler, Sabune* (Harvard)
Kitterman, Darlene* (OHSU)
Wootton, Cindy (UNMHSC)
Kline, Joel* (Iowa)
Wright, Rebekah (South Carolina)
Koziel, Margaret* (UMMS)
Wright, Jonelle* (Miami)
Law, Sindy (UCSF)
Wun, Ted (UC Davis)
Lee, Kathryn (UCSF)
Yasko, Laurel* (Pittsburgh)
Lee, Susan (UC San Diego)
Young, Jamie* (Northwestern)
Legro, Richard (PSU)
Zhang, Yi* (Washington U)
Lennon, Jim (Florida)
* = Voting Member
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