Department of Clinical Research Informatics

Service Areas

The areas of focus described below represent key business areas for all initiatives and projects:

Clinical System Development and Support

Clinical System Development and Support focuses on providing clinical systems that streamline workflow processes, enhance patient safety and allow user-friendly access to reliable data that assists in the transformation of data into information and knowledge. Clinical systems supported include CRIS/Allscripts Sunrise Acute Care Management (our hospital information system) and multiple clinical information systems which include a radiology information system, laboratory information system, transcription system, barcoding system, nutrition system and many more that will be described under the CRIS section of this document. This area also focuses on:

• Translating business requirements into working components of our clinical information systems.
• Implementing systems and enhancements that focus on the facilitation of clinical research workflow and seeking opportunities to improve clinical processes while enhancing system functionality.
• Incorporating NIH, HHS, national data, decision support, and communication standards into system development to facilitate clinical care, system interoperability, and research.
• Developing data interfaces between systems to promote data integrity and highly available and consistent data between systems.
• Managing system implementation risk through a robust testing process, which includes the translation of functional requirements into functional test cases, and the development of test scenarios from "day in the life" business processes.
• Developing custom functionality within the Hospital Information System to support clinician workflows, enhance clinical decision support, and integrate data from other systems.

Administrative System Development and Support

Administrative System Development and Support focuses on providing administrative systems that streamline and enhance workflow processes and allow user-friendly access to reliable data that assists in the transformation of data into information and knowledge that facilitate sound decision making. Examples of administrative systems include Admissions-Travel-Voucher (ATV), the Occurrence Reporting System, applications for Patient Recruitment to manage the recruitment process (from potential patient contact to payment of healthy volunteers), and the Data Transformation Initiative. A complete list is reviewed under the Technologies Section. This area also focuses on:

• Translating business requirements into working components of our administrative information systems.
• Designing systems that focus on the facilitation of workflow and seeking opportunities to improve processes while enhancing system functionality.
• Supporting NIH clinical researchers and Clinical Center (CC) departments in achieving their goals by assisting them in all areas of software systems development, management and procurement.
• Supporting development and implementation of CRIS Administrative applications through integrated testing, delivery of instruction and facilitation of customer utilization of applications to support the workflow of administrative processes.

Technical Infrastructure/Data Center Management

Technical Infrastructure/Data Center Management focuses on providing a secure, dependable technical environment that supports the increasing requirements that evolve with improving clinical and administrative systems. This area also focuses on:

• Maintaining a high availability of critical computer and networking systems and providing prompt, courteous technical support in a cost effective and timely manner.
• Providing comprehensive networking support that anticipates, meets, and exceeds our customer's service level agreements in a dynamic operational environment.
• Ensuring computers, printers, and communication devices are available and managed effectively to support CC departments and NIH research.
• Supporting and promoting the goals of DCRI by seeking and engaging in active research and collaborative work within the NIH community as well as with academia and industry - work in which knowledge in the biomedical and computing sciences is advanced, and from which practical results that directly lead to better health care for everyone are realized.

Customer Support

Customer Support focuses on enhancing customer satisfaction in the areas of clinical and technical support, including:

• Providing customer-focused and staff-focused, quality IT services and technical support which assists our customers in making the best use of the newest biomedical technologies and existing information technologies in support of their business function.
• Supporting development and implementation of CRIS applications through delivery of instruction and facilitation of customer utilization of applications to support the workflow of clinical research studies and care.

Department Store

The DCRI Store is a service where departments can order both stock items such as the CC standard configuration desktop, laptops, and special order items like software applications, special computer and laptop configurations as well as other IT specific items.

Security & Privacy

Security and Privacy focuses on the security of all clinical, research and administrative systems and maintains the privacy of sensitive confidential information related to patients, employees and contractors contained therein according to the requirements established by the Privacy Act of 1974. While most systems are under the control of DCRI Technical staff, the team is also responsible for ensuring the security and privacy of systems under the control of CC departments and third party applications hosted off-site. This area also focuses on:

• Providing protection of sensitive information by ensuring the "Confidentiality, Integrity and Availability" for all clinical and administrative systems.
• Conducting Security assessment & Authorizations (SA&A) on CC IT systems to include: security control testing, risk assessments, system security plans, Plan of Action & Milestones (POA&M) documentation, contingency plans, and configuration management plans. All CC IT Systems, Data Centers and Networks in the CC's system inventory undergo the SA&A process and achieve an Authority to Operate (ATO).
• Continuously monitoring the security and privacy of IT systems for effectiveness and consistency with pre-established requirements as related to established NIST, OPM, and NIH standards.
• Ensuring CC staff complete Annual Security Awareness and Privacy Awareness training.
• Ensuring CC staff with significant responsibility complete HHS Role-based Information Security courses.
• Completing Privacy Impact Assessments (PIA) for all CC IT systems using HHS tools, to ensure the protection of personally identifiable information (PII). Reporting on PIA completion and other related information to HHS and the Office of Management and Budget (OMB) in par with the Federal Information Security Management Act (FISMA) is also accomplished.
• Providing consultation on security and privacy throughout the lifecycle of new and existing CC IT systems; i.e., procurement, design, development, implementation, operations & maintenance and disposition.
• Investigating, reviewing and reporting on all potential privacy act violations involving CC Systems and CC staff.
• Investigating, analyzing, remediating, and reporting on all security vulnerabilities identified by the CC and NIH.
• Investigating and responding to all security and privacy incidents in the NIH Incident Response Team (IRT) Portal within established timeframes.
• Providing expert consultation of matters related to privacy, security and confidentiality, including legislation, regularity requirements and organizational standards.

Training & Outreach

Training and Outreach focuses on:

• Providing training and communication outreach to CRIS users, stakeholders and internal department members.
• Providing training and clinical support to system users, evaluating performance and effectiveness of system use, developing clinical research informatics training programs and fostering collaboration to advance knowledge.
• Developing and facilitating curriculum for internal and external training programs/fellowships, planning improvement strategies for support of clinical operations, and directing system evaluation initiatives including prototype testing, performance measurements, and satisfaction surveys.

Secure Communication with Patients, NIH Care Providers, and Outside/Referring Physicians

This business area was initiated in 2009 to focus on the secure communication of Clinical Information to patients, NIH care providers and outside/referring physicians. FY2014 priorities include secure communication between patients and the NIH Care Team within the CC Patient Portal. In FY2014 secure messaging with Referring Physicians and a Referring Physician Portal will be pursued.