Academic health systems and their investigators are challenged to systematically assure clinical research regulatory compliance. This challenge is heightened in the emerging era of centralized single Institutional Review Boards for multicenter studies, which rely on monitoring programs at each participating site.

To describe the development, implementation, and outcome measurement of an institution-wide paired training curriculum and internal monitoring program for clinical research regulatory compliance.

Standard operating procedures (SOPs) were developed to facilitate investigator and research professional adherence to institutional policies, federal guidelines, and international standards. An SOP training curriculum was developed and implemented institution-wide. An internal monitoring program was launched, utilizing risk-based monitoring plans of pre-specified frequency and intensity, assessed upon Institutional Review Boards approval of each prospective study. Monitoring plans were executed according to an additional SOP on internal monitoring, with monitoring findings captured in a REDCap database.

We observed few major violations across 3 key domains of clinical research conduct and demonstrated a meaningful decrease in the rates of nonmajor violations in each, over the course of 2 years.

The paired training curriculum and monitoring program is a successful institution-wide clinical research regulatory compliance model that will continue to be refined.

A core challenge of a multidisciplinary and multi-organizational translational research enterprise such as a Clinical and Translational Research Award (CTSA) is coordinating and integrating the work of individuals, workgroups, and organizations accustomed to working independently and autonomously. Tufts Clinical and Translational Science Institute (CTSI) undertook and studied a multifacted intervention to address this challenge and to create a culture of systems thinking, process awareness, responsive to others' needs, and shared decision-making.

The intervention, based on relational coordination, included 1) relational interventions, in three staff retreats and a diagnostic survey to provide feedback on the current quality of relational coordination, and 2) structural interventions, in the launching of five new cross-functional teams with regular meeting structures.

A mixed-methods evaluation yielded quantitative data via two types of team surveys and qualitative data via interviews and meeting observations.

The findings suggest that interventions to improve relational coordination are feasible for CTSAs, including good fidelity to the model and staff/physician engagement. Survey and interview data suggest model improvements in coordination and alignment. Further research about their optimal design is warranted.

The National Clinical and Translational Science Award (CTSA) Consortium 2.0 has developed common metrics as a collaborative project for all participating sites. Metrics address several important aspects and functions of the consortium, including workforce development. The first workforce development metrics to be proposed for all CTSA hubs include the proportion of CTSA-supported trainees and scholars with sustainable careers in translational research and the diversity and inclusiveness of programs.

The University of Utah Center for Clinical and Translational Science (CCTS), a CTSA hub, has been actively engaged in mentoring translational scientists for the last decade. We have developed programs, processes, and institutional policies that support translational scientists, which have resulted in 100% of our KL2 scholars remaining engaged in translational science and in increasing the inclusion of individuals under-represented in medicine in our research enterprise. In this paper, we share details of our program and what we believe are evidence-based best practices for developing sustainable translational research careers for all aspiring junior faculty members.

The University of Utah Center for Clinical and Translational Science has been integral in catalyzing interactions across the campus to reverse the negative trends seen nationally in sustaining clinician scientists. Our programs and processes can serve as a model for other institutions seeking to develop translational scientists.

The Institute of Translational Health Sciences (ITHS), a Clinical and Translational Science Award (CTSA)-funded program at the University of Washington (UW), established the Drug and Device Advisory Committee (DDAC) to provide product-specific scientific and regulatory mentoring to investigators seeking to translate their discoveries into medical products. An 8-year retrospective analysis was undertaken to evaluate the impact of the DDAC programs on commercialization metrics.

Tracked metrics included the number of teams who consulted with the DDAC, initiated a clinical trial, formed a startup, or were successful obtaining federal small business innovation awards or venture capital. The review includes historical comparisons of the startup rates for the UW School of Medicine and the Fred Hutchinson Cancer Research Center, two ITHS-affiliated institutions that have had different DDAC utilization rates.

Between 2008 and 2016, the DDAC supported 161 unique project teams, 28% of which went on to form a startup. The commercialization rates for the UW School of Medicine increased significantly following integration of the DDAC into the commercialization programs offered by the UW technology transfer office.

A formalized partnership between preclinical consulting and the technology transfer programs provides an efficient use of limited development funds and a more in-depth vetting of the business opportunity and regulatory path to development.

UMHealthResearch is the University of Michigan’s digital health research recruitment platform. It allows health researchers to connect efficiently with potentially eligible volunteers.

In 2013, the UMHealthResearch team strategically adapted a consumer behavior model, the buying funnel, to create the Digital Health Research Participation Funnel. The Digital Health Research Participation Funnel was then used to design a more active way for potential participants to volunteer for research studies through UMHealthResearch.

In the 5 years before the redesign (2007–2012), an average of 1844 new accounts were created every year, whereas in the completed years after the redesign (2013–2016) the annual average improved to 3906, an increase of 111%.

Although a randomized design was not possible in this instance, these preintervention and postintervention data suggest that the focus on user experience is an effective strategy for improving web-based research recruitment platforms.

We aimed to improve the research consenting process by developing and evaluating simplified consent forms.

Four templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates.

At baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them (p<0.001).

Consent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.

Given the reach and influence of social media, the National Children’s Study Vanguard Study evaluated the feasibility, acceptability, and cost of using social media to support participant retention.

We describe a social media experiment designed to assess the impact of social media on participant retention, discuss several key considerations for integrating social media into longitudinal research, and review factors that may influence engagement in research-related social media.

User participation varied but was most active when at launch. During the short life of the private online community, a total of 39 participants joined. General enthusiasm about the prospect of the online community was indicated. There were many lessons learned throughout the process in areas such as privacy, security, and Institutional Review Board clearance. These are described in detail.

The opportunity to engage participants in longitudinal research using online social networks is enticing; however, more research is needed to consider the feasibility of their use in an ongoing manner. Recommendations are presented for future research seeking to use social media to improve retention in longitudinal research.