Clinical & Research Informatics

Eunice Kennedy Shriver National Institute Of Child Health & Human Development

Investigators

Linked publications & trials

Abstract

Core IT Services Over the past year, the Computer Support Services Core (CSSC) continued to deliver reliable, secure, and efficient information technology solutions that support DIR’s research IT ecosystem. This support includes acquisition, maintenance, and management of licensed software essential to our research community, such as GraphPad Prism, Amira, DNASTAR Lasergene, MathWorks MATLAB, SnapGene, FlowJo, Grammarly, and Biorender, as well as cross-platform desktop, server, and application hosting services. We worked closely with the software vendors to organize NICHD/DIR–centric user training sessions on BioRender and DNASTAR, which attracted a large number of attendees from the research community. We also assisted users in identifying, researching, and purchasing custom hardware configurations tailored to specific research workflow requirements. In response to the growing interest in leveraging advancements in generative AI, we collaborated with stakeholders to contribute to an IRP-wide report, which includes a set of recommended actions to support adoption adoption of this emerging technology within the intramural program. The addition of a new Deputy Scientific Information Officer (SIO) in 2023 enabled the CSSC to expand its support and collaboration efforts. Key accomplishments included piloting backup and storage initiatives with NICHD's Office of Information Technology (OIT), vastly expanding VLAN (Virtual Local Area Network) offering, establishing regular meetings with NICHD's scientific support team, and regular meetings with OIT’s DIR Customer Relations Lead. We expanded outreach to intramural investigators and SIO peers in other NIH Institutes, Centers, and Offices (ICOs), participated in NIH–wide working groups, streamlined scientific software-license management, and strengthened security capacity for the intramural community. The CSSC proactively engaged research staff to provide consultative support on technical needs and emerging issues, including strategic discussions on AI/ML policies discussions and potential Cloud adoption for DIR labs. In the last year, we implemented the NIH intramural Electronic Lab Notebooks (ELN) initiative. The CSSC contributed to creating the NIH’s first lab-safety recommendations for personal mobile devices. We assisted labs in navigating complex NIH–level rules on Record Management, Education, Technology Transfer, and Research Integrity. We studied and piloted options for portable technology to facilitate the adoption of ELN in the bench labs. We also worked with peer SIOs to establish the guidelines for computational lab notebooks. We developed comprehensive documentation for the DIR, including wikis for ELN and general IT–related topics to support knowledge sharing and scientific efficiency. Clinical Informatics The CSSC met several information technology–modernization objectives in the past year. To meet the Federal Cloud Computing Strategy objectives of achieving savings, security, and faster delivery of services, the CSSC has modernized with platform-as-a-service (PaaS) solutions on Federal Risk and Authorization Management Program (FedRAMP) authorized cloud service providers (CSP). Building upon the NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative, CSSC developed standardized, compliant cloud environments to provide consistent, expedited deployment of services for our research systems. This solution allows researchers to efficiently and securely host static content websites and web applications/databases in the cloud while redirecting all network traffic through the NIH Trusted Internet Connection (TIC). The operational expense of this environment significantly reduces NIH obligations when compared with hardware capital expenses, vendor licensing, and labor/support costs associated with on-premises data centers or cloud infrastructure-as-a-service (IaaS) solutions. Improving the security posture of our systems, this configuration explicitly prohibits access to all underlying host systems and applies extensive defense-in-depth security controls, including firewalls, network segmentation, multi-factor authentication, system roles, service policies, data encryption, and continuous, automated monitoring. Distributed across multiple availability zones, the platforms allow us to leverage service level agreements for highly available and durable computing and database services. To ensure operational continuity as all the CSSC systems incrementally transition to cloud services, we upgraded the remaining on-premises infrastructure to meet current resource requirements. During the next year, the CSSC will release a PaaS cloud–hosted Clinical Trials Database with a modernized user interface (UI) and user experience (UX). The CSSC continued to support and develop applications related to clinical and translational medicine, including the Clinical Trials Database (CTDB) project. Such informatics tools allow researchers to design, collect, and report clinical observations related to natural history and interval-based studies. The total number of protocols and research projects supported by the CTDB team for 15 NIH institutes increased to 794 studies. The Global Question Library expanded to over 367,000 research questions. Our software development group completed four CTDB releases including a major redesign released in June 2025. Features also included improvements to the e-binder module, Quality Assurance Queries, Forms module and Samples module. We supported the Clinical Trials Survey System (CTSS), an application for patient self-reporting, servicing 63 active protocols. The team completed one CTSS release to include validations and updates to skip rules to improve the quality of data. The CTDB application also supports the NICHD Office of Clinical Director (OCD) central biorepository and eligibility monitoring; the CTDB team supports the NICHD OCD with customized report integrating with eligibility monitoring workflow. Through the global library in CTDB, several institutes track research teams' CVs, training, and certificate documentation. In the past year, the CTDB team continued supporting the NICHD's Division of Population Health Research (DiPHR) with seven sites, worked with NHLBI to refine and improve adverse event (AE) reporting, and assisted in several DASH (Data and Specimen Hub, which allows researchers to share and access de-identified data from studies) submissions. In May 2024, the CTDB project received a renewed 21 CFR Part 11 certification (part of Title 21 of the Code of Federal Regulations that establishes the FDA regulations on electronic records and electronic signatures). Since this project's inception, data from CTDB supported over 1,500 NICHD publications. The data services team continued integrations with other NIH institutes, the Clinical Center, and the Biomedical Translational Research Information System (BTRIS) and CRIS (Clinical Record Interactive Search) projects. The team worked with NHBLI CMRCoop (Cardiac Magnetic Resonance Cooperative) system, NIDCD audiology system, and NIMH projects, to incorporate data from these systems into the CTDB data-analytics platform. The team continues to provide substantial ongoing support to PIs across 15 NIH Institutes and Centers and several external research organizations (MedStar, Inova, and John Hopkins), to deliver data-quality and research-related reports, scoring, and analysis for clinical studies, and publishing more than 300 data sets in the past year. Custom software development for scientific and administrative support The CSSC provides custom software development for the DIR's scientific and administrative community. The application-development team migrated all scientific and administrative support applications to the Azure STRIDES cloud platform. We continued to enhance the Manuscript Tracking System (MTrac), a web-based application that automates the clearance and approval process for manuscripts in the DIR. Most notably, we developed a major enhancement to provide another layer of approval from NICHD’s Office of Communications for specific types of submissions. The DIRweb application supports several activities: the NICHD Annual Report, PI and Fellows' retreats, training tracking, Fellows’ progress reports, and Administrative Management Branch's (AMB) personnel and travel-package tracking. The DIRweb includes lab training web services for the NIH Enterprise Directory and Division of Occupational Health and Safety Training. The team continued to release enhancements to the Fellows Annual Progress Report, a unified means for tracking and mentoring intramural trainees as well as for easing the re-appointment process. This solution provided the Office of Education with useful metrics regarding mentoring and training programs. Another major enhancement to the progress-report system was the addition of an Individual Development Plan and Annual Progress Reports for postbaccalaureate fellows. We also updated the Exit Survey feature, a short survey giving DIR fellows a platform for providing feedback. We continued to develop new features and improvements for the Personnel and Travel Package Tracking module used by the AMB, providing AMB staff real-time accuracy metrics for personnel and travel package compilation. The team has also improved upon the Capital Equipment/Expenditure Request Tracking System, which allows users to efficiently submit requests through the review process, while giving administrative staff the ability to track requests through the workflow process. Additional features allow administrative staff to process and track requests after approval and funding. The project has been sufficiently well received to allow potential offerings to the NICHD extramural community as well as to the Office of the Director. The CSSC team continued maintenance of Cost Tracker, an application that permits capturing, organizing, and reporting various expenses on a per-protocol basis. The work is done closely with the OCD to improve protocol cost vs. effectiveness and provides a protocol-cost estimator module. The CSSC team continues to develop and support several feedback systems to support real-time customer satisfaction collection. These include surveys for the AMB, the OCD, laboratory administrative support staff, and NICHD's Administrative Services Branch. A new feedback system was also developed for NICHD’s Office of the Scientific Director. The system also offers more detailed feedback submissions periodically, along with more comprehensive response metrics than was previously possible. Along with application development, maintenance, and support, the CSSC team successfully migrated infrastructure and applications to Azure Cloud using NIH STRIDES one of the first organizations to do so. Biological Visualization Services The CSSC team provided DIR laboratories with scientific communications and media services, including publication support and website support. These services were provided to: The NICHD DIR Annual Report, the DIR Annual Fellows Retreat, the DIR Annual Scientific Retreat, and the NICHD research labs and medical training programs. For intramural labs, we created scientific figures and illustrations for publication in medical and scientific journals. We supported the NICHD Office of Education by producing a monthly newsletter, The NICHD Connection, in collaboration with Intramural Fellows, the monthly Scientific Directors Bulletin for staff, and promotional posters and graphics for sponsored events. We continued maintaining websites for the NICHD DIR Annual Report and DIR Annual Fellows Retreat. The CSSC continued to provide a platform for conducting scientific review by the Board of Scientific Counselors, administrative intranet support, and business operations.