ITHS in-kind services

Biomedical Informatics (BMI) facilitates clinical and translational research innovation and implementation with technology and data, including use of electronic health record (EHR) data and tools for acquiring and managing biospecimen and study data. In addition to supporting data pulls at partner institutions, we established a regional data sharing architecture, Data QUEST. This resource provides access to electronic health datasets from community-based primary care clinics in the Northwest United States.

Biostatistics, Epidemiology, and Research Design (BERD) provides a comprehensive set of services and education including consultations, novel study designs, and investigator ready tools to promote rigorous and efficient clinical and translational research. Our team provides complete data coordinating support, in partnership with BMI, including leadership for large clinical trials involving a variety of study designs.

The Adult Translational Research Unit (TRU) provides access to dedicated research space with patient rooms, specially trained nursing staff, a CLIA-certified laboratory processing room, 2 and state-of-the-art equipment. Nursing support may include IV infusions, monitoring of adverse events, frequent vital signs, EKGs, and high volume and closely timed blood draws. Space is available for consenting patients, administering questionnaires, and conducting physical examinations.

The Pediatric Clinical Research Center (PCRC) at Seattle Children’s provides space and resources to conduct clinical and translational research in children less than 21 years of age. PCRC offers dedicated research space with patient rooms, Good Clinical Practice (GCP)- and Pediatric Advanced Life Support (PALS)-certified nursing staff, and state-of-the-art equipment. Nursing support may include IV infusions, monitoring of adverse events, frequent vital signs, EKGs, and high volume and closely timed blood draws. Both the TRU and PCRC have mobile on-call nurses to travel to inpatient units within their respective hospitals to ensure that all research protocols can be accommodated during anticipated and unanticipated admissions while a patient is enrolled in a research study. These mobile nurses can also be sent to ambulatory clinics or other settings where clinical research is conducted for the convenience of the participants and investigators.

The Regional Clinical Dental Research Center (RCDRC) provides facilities, resources, and personnel to conduct translational and clinical research related to oral diseases. Facilities include two oversized dental operatories and a biomedical laboratory for initial specimen processing and an area for coordinator activities. Personnel support includes research project coordination, regulatory management, participant recruitment, dental hygiene/dental assisting services, and study design and implementation consultation. RCDRC personnel are available to provide research services in other units and clinics and are experienced in the logistics of conducting field research, with flexible scheduling available.

The Gene and Cell Therapy Lab (GCTL) provides researchers with infrastructure, training, and technical expertise to facilitate translation of promising cell-based therapies. The GCTL can be contracted to manufacture gene- and cell-based clinical products for therapeutic applications that are compliant with standards set by FDA and state and local regulatory bodies. GCTL is a Current Good Manufacturing Practices (cGMP) facility that maintains its good standing with regular audits and regulatory filings. GCTL can also train and qualify researchers to work within GCTL facilities to be a part of the team manufacturing cell products.

The Research Coordination Center (RCC) is a multidisciplinary team of research coordinators, regulatory specialists, and study monitors providing creative research staffing solutions for projects that involve human research participants. We offer support in completing IRB and other regulatory applications, study monitoring, study start-up, and protocol implementation. Our team is experienced in creating customized REDCap databases to electronically collect data for clinical trials, administer surveys, and create longitudinal studies. RCC staff can also provide training to your staff to help you develop a strong research team.

Community Engagement supports matching and partnerships with clinical and community collaborators across WWAMI. Our team of expert can work with investigators to develop effective engagement plans, assess training needs and research capacity, and provide ongoing technical support. We provide guidance on returning study results to communities and tools for improving adaptation and adoption of evidence-based discoveries in diverse settings. We also offer assistance with protocol development, grant proposal preparation, and implementation of funded projects. The WWAMI region Practice and Research Network (WPRN), a network of almost 90 clinics, offers investigators tools and connections to conduct collaborative research in community-based primary care settings.

The Northwest Participant and Clinical Interactions (NWPCI) Network is a consortium of clinical and translational research centers dedicated to providing access to high quality research across the ITHS partners and the WWAMI region, with research staff and administrative support for budgeting and compliance infrastructure.

The Scientific Success Committees (SSC) is available to review clinical study design and feasibility, giving investigators feedback early in project planning. SSC members include highly experienced clinical investigators as well as experts in biostatistics, bioethics, and community engagement. The committee can offer guidance in all aspects of study design, including development of research questions, approach, outcome measures, feasibility, clinical appropriateness, and statistical planning.

We have also developed programs to support early-stage drug and device development. Academic investigators seeking to move a drug or device through preclinical testing to the clinic and commercialization have access to experts who are experienced in developing regulatory, clinical, and business plans. Support may include customer discovery, market research and strategy, business plan development, regulatory application, as well as helping connect

investigators with mentors and investors.medical centers.

The Dissemination and Implementation (D&I) Program helps investigators identify strategies to accelerate adoption of guidelines or interventions and refine research plans and products for successful implementation in real-world settings. We can help investigators select methods and tools to scale up and spread their research findings, identify appropriate clinical or community-based settings, and connect you with key stakeholder representatives and potential research partners. We can also assist with identifying valid measures, tools, and study design to evaluate the effectiveness of implementation practices.

The Research Bioethics program provides advice on any ethical issues that may arise during the development, implementation, or analysis of clinical and translational research. The team has expertise in bioethics, medicine, and law and offers investigators a forum for in-depth

conversation and analysis to help improve the quality of their research.

Integrating Special Populations (ISP) seeks to increase engagement of underrepresented children and older adults in research across WWAMI, partnering with a Health Equity Community Advisory Council. ISP helps investigators identify strategies to accelerate adoption of guidelines or interventions and refine research plans and products for successful implementation in real-world settings.

Network Capacity aims to address barriers to site participation in multicenter clinical trials and challenges in recruitment, retention, and monitoring. We developed a Recruitment Support Service offers both pre- and post-award guidance on study-specific recruitment and retention

strategies throughout the lifespan of a study. One area of focus is helping teams consider use of e-consenting and other remote technologies in research to reduce the impact of in-person visit restrictions and to broaden participation beyond the reach of academic medical centers.

Team Science brings together leaders in team research, recognition, and coaching to support development, performance, and recognition of high functioning interdisciplinary teams through education and institutional policy. Our goal is to build diverse, agile teams that can readily integrate researchers from distinct disciplines and community stakeholders to address challenges and opportunities in clinical and translational research. Current offerings include online training, an Annual Team Science Boot Camp, executive coaching, and Lean project management training. We also offer tools to support the recognition of interdisciplinary research and collaboration in academic career advancement.

Translational Workforce Development (TWD) provides a range of educational options for students, faculty, and research staff. TWD partners with other ITHS programs to provide lifelong learning opportunities including:

• The Career Development Series, a bi-monthly seminar targeted to early-stage investigators. The series focuses on practical tools necessary for a successful career in research and academia. Topics have included grantsmanship, scientific writing, data visualization, mentoring, team science, and presentation skills.
• The Clinical Research Education Series, a  continuing education and training series for research coordinators, other research staff, and investigators focused on clinical research topics such as informed consent and single IRBs.