Risk Stratification Project Newsletter
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From this document you will learn the answers to the following questions:
What is the profession of Subra Kugathasan?
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What is the name of the organization that provides the services to the sick?
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1 September 29 Risk Stratification Project Newsletter S P O N S O R : C R O H N S A N D C O L I T I S F O U N D A T I O N O F A M E R I C A Editorial Support: Laketia Woodley 215 Uppergate Drive, Suite 241B, Atlanta, GA 3322 Tel: STEERING COMMITTEE: Subra Kugathasan, MD (E): skugath@emory.edu (P): Marla Dubinsky, MD Cedars-Sinai (E): marla.dubinsky@cshs.org (P): Robert (Bob) Baldassano, MD Children s Hospital of Philadelphia (E): baldassano@ .chop.edu (P): Bruce Aronow, PhD (E): bruce.aronow@cchmc.org (P): Lee (Ted) Denson, MD (E): lee.denson@cchmc.org (P): Jeffrey (Jeff) Hyams, MD Connecticut Children s Medical (E): jhyams@ccmckids.org (P): James (Jim) Markowitz, MD Schneider Children s Hospital (E): jmarkowi@nshs.edu (P): Thomas (Tom) Walters, MD Hospital for Sick Children (E): thomas.walters@sickkids.ca (P): Michael Stephens, MD Medical College of Wisconsin (E): mstephen@mcw.edu (P): NEWSLETTER HIGHLIGHTS::: Page 2: Site Enrollment Numbers & New Site News and Updates Page 3: Agenda for Investigators meeting in December Hollywood, FL. Page 4: Important Clinipace Announcement/ Milestone Page 5: Contact information for sites We would like to say congratulations and send our appreciation to Dr. Sandy Kim and Dr. Michael Kappelman at UNC-Chapel Hill on the approval of their IRB and subsequent enrollment of their first patient. They have gotten off to a great start with our project and we are glad to have you all aboard. Once again thank you. CONFERENCE CALL The next Risk Stratification conference call will be held on Friday, October 16th from 12:-1:PM EST. Toll-free dial in number: International Callers: Enter conference code:
2 September 29 PATIENT ENROLLMENT INFORMATION SITE/ENROLLMENT INFORMATION SITE # SITE # NAME COORDINATOR NO. PATIENTS ENROLLED 1 Courtney Galloway 4 2 Cedars-Sinai Sharmayne Farrior 12 3 Children s Hospital of Philadelphia Kelly Cochlin, RD, LDN 27 4 Kathleen Lake, MSW, LISW, CCRC 36 5 Connecticut Children s Miriam Lincoln 45 6 Medical College of Wisconsin Kristin Ciezki 18 7 Schneider Children s Hospital Kathy Grancher 13 NEW SITE NEWS & UPDATES NAME IRB STATUS MTA STATUS NO. PATIENTS ENROLLED 8 University of California, San Francisco Submitted 9 Nationwide Children s Center Ohio In Process 1 Harvard Medical School Children s Hospital Boston In Process 11 Texas Children s Hospital Submitted 12 University of North Carolina at Chapel Hill Approved 13 Sick Kids, Canada Submitted Approved for Signature 1 Page 2
3 September 29 CCFA RISK STUDY INVESTIGATORS MEETING AGENDA Wednesday, December 3, 29 Westin Diplomat Hotel (Room TBA) 4: - 5: pm 1) Welcome 2) Progress Report - Repository; Enrollment; Database 3) MTA 4) Protocol Revisions/Amendments 5) Study Manual Revisions/Amendments 6) Enrollment Targets 5: - 6: pm 7) Selection of Subcommittees a. Publication Subcommittee b. Analytic Subcommittee 8) Microbial Component (Revisiting) by Sandy Kim and Ted Denson 6: - 7: pm 9) Preliminary results/analysis 1) Studies/substudies for Year 21 11) Abstract planning for 21: a) NASPGHAN - deadline June 21 b) CCFA-Advances - deadline October 21 ENROLLMENT PROJECTION CHART: Benjamin Rambo-Martin -1/9 Benjamin Rambo-Martin -1/9 The light blue columns represent total patient enrollment from all RISK Study sites after each month since the beginning of collection. The blue line is a linear function of these data, projecting enrollment based on the current rate of enrollment. The orange line is also a linear function, predicting enrollment from 13 active sites involved in Phase II, assuming that the new sites recruit patients at the current sites' average rate of 2.35 patients per site, per month. The purple line predicts enrollment based on 21 active sites, collecting in Phase III. If we keep up with out projection, we should reach our enrollment target by July 21, allowing 36 months for follow-up period during funding years. Page 3
4 September 29 GOING LIVE OCTOBER 12, 29 We have the process in place at Emory to enter the entire data from sites to clear the backlog as soon as the database goes live. Please be sure to contact Teresa Stilley for information on where your sites enrollment information should be sent. Page 4
5 SITE CONTACTS: SITE STUDY COORDINATOR SITE STUDY COORDINATOR Subra Kugathasan, MD (PI) Tel: Courtney Galloway Tel: Fax: Schneider Children s Hospital James Markowitz MD (Jim) jmarkowi@nshs.edu Tel: Kathy Grancher kgranche@nshs.edu Tel: Fax: Cedars-Sinai Marla Dubinsky MD marla.dubinsky@cshs.org Tel: Children s Hospital of Philadelphia Robert (Bob) Baldassano, MD baldassano@ .chop.edu Tel: Lee Denson MD (Ted) lee.denson@cchmc.org Tel: Connecticut Children s Medical Center Jeffrey Hyams MD (Jeff) jhyams@ccmckids.org Tel: Medical College of Wisconsin Michael Stephens MD mstephen@mcw.edu Tel: Sick Kids, Canada Anne Griffith, M.D. anne.griffiths@sickkids.ca OTHER KEY CONTACTS Sharmayne Farrior Sharmayne.farrior@cshs.org Tel: Fax Kelly Cochlin RD, LDN cochlinke@ .chop.edu Tel: Fax: Kathleen (Katie) Lake MSW, LISW, CCRC kathleen.lake@cchmc.org Tel: Pager: Fax: Miriam Lincoln mlincoln@ccmckids.org Tel: Fax: Kristin Ciezki kciezki@mcw.edu Tel: Fax: Dr. Kathleen Kelleher. Harvard Medical School Children's Hospital Boston Richard Grand, MD Richard.grand@childrens.harvard.edu Tel: Jessica Lee, MD Jessica.lee@childrens.harvard.edu Tel: Nationwide Children s Center - Ohio Wallace Crandall, M.D. wallace.crandall@nationwidechildrens.org Tel: University of California, San Francisco Mel Heyman, M.D. mheyman@peds.ucsf.edu Tel: Texas Children s Hospital George Ferry, M.D. gdferry@texaschildrens.org Tel:: University of North Carolina, Chapel Hill Michael Kappelman, M.D. michael_kappelman@med.unc.edu Tel: Sandy Kim, M.D. skim@med.unc.edu Helen Hood Helen.hood@childrens.harvard.edu Tel: Fax: TBA Fax: Elizabeth Liz Garnett garnette@peds.ucsf.edu Tel: Fax: Antoine Opekun BS, PAC, aropekun@texaschildrenshospital.org Tel: Fax: Katie McLean katherine_mclean@med.unc.edu Tel: Pager: Institute / Organization Project Managers Contact Information Crohn s & Colitis Foundation of America Clinipace Data and Statistics Hospital for Sick Children Teresa Stilley Research Manager Saleena J. Marria MS, MBA Research Project Manager Joy Hughes Senior Project Manager Laketia Woodley Risk Stratification News Editor / Assistant to Dr. Subra Kugathasan Thomas (Tom) Walters, MD Chart design, data collection. 215 Uppergate Drive Suite 244 Atlanta, GA Park Avenue South 17th Fl. New York, NY Paramount Pkwy, Suite 1 Morrisville, NC Uppergate Drive Suite 241B Atlanta, Georgia 3322 tstille@emory.edu Tel: Fax: smarria@ccfa.org Tel: Fax: Website: jhughes@clinipace.com Tel: x111 Website: twoodle@emory.edu Tel: Fax: thomas.walters@sickkids.ca Tel: Bruce Aronow PhD Bioinformatics and Biostatistics Mi-Ok Kim, PhD Biostatistics bruce.aronow@cchmc.org Tel: Fax: miok.kim@cchmc.org Tel: Fax: Prepared by Subra Kugathasan, MD. Teresa Stilley Saleena J. Marria, MS, MBA
Risk Stratification Project Newsletter
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