May 2007 CTMS Workspace Update John Speakman caBIG™ Clinical Trials Management Systems Teleconference July 24, 2007

2 2 Agenda CTMS Web Site CTMS Workspace Management Changes within Booz Allen Hamilton Special Interest Groups Task Forces Steering Committee Meeting, August 2 Next Face-to-Face Meeting “Almost certainly” week beginning November 12 in Chicago (after AMIA)

3 3 CTMS Web Page

4 4 CTMS Workspace Management Changes New workspace lead starts September 4: Derek Walker Interim Workspace Lead: Diane Rickman General enquiries Program Manager: Julie Holtzople Specific enquiries: Developer / adopter contract holders Workspace Support: Susan Varghese Specific enquiries: Workspace / Task Force members NCI Clinical Trials Program Manager: John Speakman

5 5 SIG Meetings All SIG meetings are open to the community Information on the SIG meetings are posted to the Listserv ( SIG Members are encouraged to provide input and feedback on the projects via the following mechanisms: Participate in SIG calls, Workspace calls and face-to-face meetings Participate in community demonstrations of applications that are under development (announced via the CTMS and SIG Listserv) Contact a Task Force member Contact a Steering Committee member Contact SIG Lead or Facilitator Contact CTMS Workspace Lead

6 6 CTMS SIGs: Telcon Schedule and Listservs SIGTeleconferenceListserv ( Planning / Monitoring 3 rd Tuesdays 2:00 – 4:00 PM EDT Study Conduct 3 rd Wednesdays 3:00 – 5:00 PM EDT Reporting / Sharing 4 th Wednesdays 3:00 – 5:00 PM EDT Interoperability 4 th Tuesdays 2:00 – 4:00 PM EDT

7 7 CTMS SIG Listservs: How To Subscribe Browse lists at NIH Listserv List page Select Listserv of choice Click on “Join or leave the list, or update options” Enter address and full name and click on “Join the List.” Upon receipt of confirmation , click on link provided within the to finalize subscription. To unsubscribe from any list, please visit the NIH Listserv List page and click on the specific listserv link. Click on “Leave the List”, enter address and full name, and click on “Leave the List.”

8 8 Planning/Monitoring Task Force Members (current, not final) Sarah BlendermannPfizer, Inc. Susie BullockUniversity of Texas MD Anderson Cancer Center Jack LondonThomas Jefferson University / Kimmel Cancer Center Christine McLarenUniversity of California at Irvine / Chao Family Cancer Center Sorena NadafVanderbilt-Ingram Cancer Center Diane PaulConsumer Advocates in Research and Related Activites George RedmondNCI Cancer Therapy Evaluation Program Ann SetserNCI Cancer Therapy Evaluation Program Donna ShrinerNCI Cancer Therapy Evaluation Program Judy SmithNCI Division of Cancer Prevention

9 9 Study Conduct Task Force Members (current, not final) Don ConnellyUniversity of Minnesota Angela DenicoffNCI Cancer Therapy Evaluation Program Rhonda FacileClinical Data Interchange Standards Consortium Shanda FinniganNCI Cancer Therapy Evaluation Program Lara FournierOregon Health & Science University Andrea HwangUniversity of California at Irvine Bob LaneseCase Western Reserve University Beverly MeadowsNCI Division of Cancer Prevention Joyce NilandCity of Hope National Medical Center Diane PaulConsumer Advocates in Research and Related Activities Dianne Reeves NCI Center for Biomedical Informatics and Information Technology Ann SetserNCI Cancer Therapy Evaluation Program

10 Reporting/Sharing Task Force Members (current, not final) James AndersonUniversity of Nebraska Rhoda ArzoomanianUniversity of Wisconsin John EllertonNevada Community Clinical Oncology Program Dawn Caron-FabioMemorial Sloan-Kettering Cancer Center Shanda FinniganNCI Cancer Therapy Evaluation Program (CTEP) Steve FriedmanNCI Cancer Therapy Evaluation Program (CTEP) Lakshmi GramaNCI Office of Communication and Education Tad McKeonSt. Jude Children’s Research Hospital Randy MillikanM.D. Anderson Cancer Center Bob MorrellWake Forest University Diane Paul Consumer Advocates in Research and Related Activities (CARRA) George RedmondNCI Cancer Therapy Evaluation Program (CTEP) Ann SetserNCI Cancer Therapy Evaluation Program (CTEP) Anne TompkinsNCI Division of Cancer Prevention (DCP) Brenda YoungAmerican College of Radiology Jamie ZwiebelNCI Cancer Therapy Evaluation Program (CTEP)

11 Interoperability Task Force Members (current, not final) Steve AlbertsMayo Clinic John BrandtUniversity of New Mexico Troy BuddNCI Division of Cancer Prevention Vijaya Chadaram *CTMSi SMEDuke University Paul CourtneyDartmouth College Sharon Elcombe *CTMSi SMEMayo Clinic Steve FriedmanNCI Cancer Therapy Evaluation Program Alan ForsytheIndependent Edward GelmannColumbia University Lakshmi GramaNCI Office of Communication and Education Gene KraussKarmanos Cancer Institute Jeffrey KrischerUniversity of South Florida Jomol Mathew *CTMSi SMEDana-Farber Cancer Institute Diane PaulConsumer Advocates in Research and Related Activities George RedmondNCI Cancer Therapy Evaluation Program Ann SetserNCI Cancer Therapy Evaluation Program

12 Steering Committee Meeting, August 2 Co-chairs: Jan Buckner (Mayo Clinic) and Sorena Nadaf (Vanderbilt) Immediate activity of Interoperability Task Force: Inventory existing clinical trial systems at NCI and at NCI-supported extramural community, prioritize systems for harmonization and interoperability. Initial activity focused on new applications that are currently being developed. Endorsed first iteration of the Clinical Trials Database - investigator/site will register trial and upload the protocol document into the cancer Clinical Trials Unified System (caCTUS) - NCI can then abstract protocol data to support investigator/site reporting of Clinical Data System (CDS) Abbreviated data set via CDS Web module. The investigator/site will be able to access comprehensive data via CDS Analysis and Reporting module.

13 Steering Committee Meeting, August 2 Endorsed plan for NCI-wide procurement and adoption of a Clinical Data Management System (CDMS). Agreed that functional, non-functional (technical), and business criteria used by the Coalition of Cancer Cooperative Groups to evaluate a CDMS should be incorporated into NCI’s evaluation process. Members will review Coalition requirements and evaluation criteria and provide feedback with specific additional requirements from the community they represent. Agreed that the Study Conduct SIG should launch five new Case Report Form (CRF) modules: Patient Identification, Patient Enrollment/ Registration, Baseline Assessment, Adverse Events, and Deviations. Endorsed the work to date on harmonization and standardization of the CRF Demography module and agreed to the proposed activities from August 2007 through January Next meeting: December 12

14 Q & A Presentation: Cancer Central Clinical Participant Registry (Duke University)