DEPARTMENT of CLINICAL RESEARCH INFORMATICS

The Department of Clinical Research Informatics (DCRI) is committed to delivering secure, responsive, high-quality, customer-oriented information technology services and support that foster excellence in clinical care and biomedical research. The areas of focus described below represent key business areas for all initiatives and projects

Clinical System Development and Support

Provide 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/Eclipsys Sunrise Acute Care Management (our hospital information system) and multiple ancillary systems which include a radiology information system, laboratory information system, transcription system, nutrition system and many more that will be described under the CRIS Section of this document.

  • Translate business requirements into working components of our clinical information systems.

  • Implement systems that focus on the facilitation of clinical research workflow and seek opportunities to improve clinical processes while enhancing system functionality.

  • Incorporate NIH, HHS, national data, decision support, and communication standards into system development to facilitate clinical care, system interoperability, and research.

  • Support the translation of clinical research information needs into system requirements and support the functional testing of clinical applications to facilitate congruency with organizational work, user access and system design developments.

Administrative System Development and Support

Provide 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 the Occurrence Reporting System, managing Survey Monkey for various CC Surveys, applications for Patient Recruitment to manage the recruitment process from potential patient contact to payment of healthy volunteers, the data transformation initiative. A complete list is reviewed under the Technologies Section.

  • Translate business requirements into working components of our administrative information systems.

  • Design systems that focus on the facilitation of workflow and seek opportunities to improve processes while enhancing system functionality.

  • Support 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.

  • Support 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

Provide a secure, dependable technical environment that supports the increasing requirements that evolve with improving clinical and administrative systems.

  • Maintain a high availability of critical computer and networking systems and provide prompt, courteous technical support in a cost effective and timely manner.

  • Provide comprehensive networking support that anticipates, meets, and exceeds our customer's service level agreements in a dynamic operational environment.

  • Ensure computers, printers, and communication devices are available and managed effectively to support CC departments and NIH research.

  • Support and promote 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

Enhance customer satisfaction in the areas of clinical and technical support.

  • Provide 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.

  • Support development and implementation of CRIS applications through integrated testing, delivery of instruction and facilitation of customer utilization of applications to support the workflow of clinical research studies

Security & Privacy

Ensure the security of all clinical, research and administrative systems under the control of DCRI and maintain the privacy of the sensitive confidential information related to patients, employees and contractors contained therein according to the requirements established by the Privacy Act of 1974

  • Provide protection of sensitive information by ensuring the "Confidentiality, Integrity and Availability" for all clinical and administrative systems.

  • Conduct security control testing and develop system security Certification & Accreditation (C&A) documentation, including formal risk assessment, overall security plans, Plan of Action &Milestones (POA&M) documentation, contingency plans, and configuration management plans for all IT Systems, Data Centers and Networks under control of DCRI.

  • Continuously monitor system security controls for effectiveness and consistency with pre-established requirements particularly as related to established NIST standards.

  • Ensure CC staff complete Annual Security Awareness and Privacy Awareness training.

  • Ensure CC staff with significant responsibility complete HHS Role-based Information Security courses

  • Complete Privacy Impact Assessments (PIA) for all CC IT systems using the Security and Privacy Online Reporting Tool (SPORT), formerly known as ProSight FISMA, to ensure the protection of personally identifiable information (PII); and report on PIA completion and other related information to HHS and the Office of Management and Budget (OMB) for Federal Information Security Management Act (FISMA) reporting.

  • Provide 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.

  • Investigate, review and report on all potential privacy act violations involving CC Systems.

  • Provide expert consultation of matters related to privacy, security and confidentiality, including legislation, regularity requirements and organizational standards.

Training & Outreach

  • Provide training and communication outreach to CRIS users, stakeholders and internal department members.

  • Provide training and clinical support to system users, evaluate performance and effectiveness of system use, develop clinical research informatics training programs and foster collaboration to advance knowledge.

  • Develop and facilitate curriculum for internal and external training programs/fellowships, plan improvement strategies for support of clinical operations, and direct system evaluation initiatives including prototype testing, performance measurements, and satisfaction surveys.

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