CTMS Workspace Meeting caBIG ® Clinical Trials Management Systems Workspace January 27, 2009

Agenda Welcome/Program Update Interoperability Use Cases Business Architecture Model update CDMS Procurement CTRP Deployment Review of Today’s Action Items

Program Update CTMS Workspace Face to Face When: March 18, 19, 20, 2009 Where: Las Vegas, Nevada Host: Nevada Cancer Institute Registration: CTMS Knowledge Center: create an account Discussion Forums - CTMS Forum - General Discussions. Add input on a discussion, e.g., Protocol Authoring Tools You will see a thread on Protocol Authoring Tools. Your input is important on this and other topics Or add your own topic!

Interoperability Use Case Review

Business Architecture Model Wiki

Business Architecture Model Use Case Status Workspace Reviewed Obtain informed Consent Develop Scientific Concept Manage Study Subject Schedule In Workspace Review – we need your input Manage Subject Study Registration (until Feb 18) Register Subject (until Feb 18) Working Group Develop Protocol and Associated Materials

Business Architecture Model Proposed BAM 1.0 release date: April 2009 Detailed review via web conference in March; also at CTMS Workspace meeting in Las Vegas, NV, March BAM wiki page Business Architecture Modeling Content List Business Architecture Model Discussion

Clinical Data Management System Procurement

CDMS Procurement NCI is purchasing licensing rights for a commercial clinical data management system (CDMS) software product (aka Remote Data Entry (RDE) or Electronic Data Capture (EDC) and related installation, support and maintenance services Will be made available free of charge to all NCI- supported organizations conducting cancer clinical trials Unlimited-user, perpetual license Includes on-site installation, training materials, telephone / support and software upgrades Can be used under the terms of this license for all cancer trials, including industry, investigator-initiated, etc. Cannot be used for non-cancer trials under this license

Procurement Update: 12/5/08 Government Accountability Office (GAO) review Determination: contract solicitation not sufficiently clear with respect to Government’s license requirements Recommendation: solicitation be amended, final proposal revisions solicited from offerors in the competitive range in support of a new award determination While we firmly disagree with the GAO’s factual determinations, we wish to minimize the delay in finalizing this acquisition Accordingly, the Department of Interior will implement GAO’s recommendation as expeditiously as possible There may still be delays Any of the losing bidders may protest the subsequent decision, which would trigger additional review by the GAO

Questions on Procurement? Further questions regarding the contract and the award process should be directed to: Louis Gilden, Contracting Officer, AQD/NBC/US DOI, 381 Elden Street, Suite 4000, Herndon VA 20170, All other questions should be directed to: George A. Komatsoulis, Ph.D., Deputy Director, NCI Center for Biomedical Informatics and Information Technology (CBIIT), 2115 East Jefferson Street, Suite 6000, Rockville, MD 20852, John Speakman, Associate Director, Clinical Products and Programs, NCI Center for Biomedical Informatics and Information Technology (CBIIT), 2115 East Jefferson Street, Suite 6000, Rockville MD 20852,

Clinical Trials Reporting Program (CTRP) Deployment

Thank you!