CANCER TRIALS SUPPORT UNIT (CTSU) CORE SUPPORT SERVICES & THE CTSU ENTERPRISE OF SYSTEMS

The Contractor shall provide operational, regulatory and informatics support to conduct clinical studies across multiple institutions for Phase 0 through Phase 3 cancer-related studies to include: 1. Operational Support a. Manage user accounts, adhere to configuration management guidelines, and operate and maintain CTSU websites.

b. Operate a customer service support help desk to support queries regarding all facets of CTSU operations.

c. Organize working groups; including Government, Multicenter Organization (MCO), other contract staff, or other appropriate parties; as needed, to develop collaborative solutions to eliminate parallel/duplicative MCO and/or contract systems and processes and improvements for activities such as those that are redundant, inefficient, or duplicative.

d. Identify potential gaps and or opportunities to supplement CTSU support services

e. Collaborate with NCI and MCOs to identify and establish standards, systems, procedures, and best practices for trial coordination. f. Collaborate with other multi-center organization(s) and/or institutions that do not traditionally work together. g. Provide MCO budget tracking support

h. Performing site auditing/central monitoring by fulfilling the auditing rules set by the Clinical Trials Monitoring Branch (CTMB) of CTEP i. Provide tools and processes that comply with NCI Data Quality Reporting and Good Clinical Practice (GCP) procedures. j. Develop International Collaboration Administrative Best Practices

k. Coordinate OMB Clearances l. Provide regulatory document tracking, management, and support m. Provide protocol documentation/development support n. Provide person and site Roster Support o. Provide Clinical Data Management System Support (CDMS) 2. Information (IT) Support a. Provide CTSU-Enterprise System (ESYS) IT Support:

b. Use best practices consistent with Capability Maturity Model Integration (CMMI) Maturity Level 3.

c. Follow all Department of Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC) practices to enhance IT governance. d. Maintain compliance with all regulatory requirements concerning patient records.

e. Secure an Authorization to Operate (ATO) in accordance with Federal Information Security Modernization Act (FISMA) and HHS IT Security requirements. f. Provide system/data back-up and disaster recovery in accordance with federal government regulations.

g. Maintain, update, enhance, and provide training (in coordination with the Awareness, Education, and Training contractor) for NCI-developed custom applications, commercial-off-the-shelf applications modified to meet NCI needs, and integrations from other applications to the included applications under this task

h. Follow best practices for configuration management located i. Follow best practices for project management.

j. For potential new applications or integrations, work with the COR and subject matter experts (SMEs) to develop a list of major technical and operational requirements.

k. For potential new applications or integrations, perform an analysis of available Commercial Off-the-Shelf (COTS) solutions for new IT initiatives that could potentially meet the project needs, to include customization of a COTS solution. The contractor shall: 1. Maintain all existing National Coverage Analysis (NCA) and Electronic Medical Record (EMR) materials.

2. Create new NCA and EMR materials for specific studies as directed by the COR. 3. Modify NCA and EMR materials due to protocol amendments. 4. Maintain a Quality Control Program for the NCA and EMR documents.

5. Create study specific, sharable EMR templates, including those for medication orders, for the common EMR systems used by major oncology centers and NCORP sites