A clinical research team’s goal is to support the implementation, conduct, and monitoring of research studies and corresponding protocols. There is a need to ensure that study teams have adequate resources and regulatory support to successfully adhere to regulations and good clinical research practices. Our team, the UC Davis Division of Infectious Diseases Research Unit (IDRU), sought to establish a One Signature Initiative program for all studies and protocols supported by the IDRU. The One Signature Initiative designates one point of contact from each ancillary team or department to sign delegation and training logs, who in turn is delegated to train their team. The goals of the One Signature Initiative were, and are still, to reduce task redundancy, lessen regulatory burden on research teams, and minimize audit findings. Since the implementation of the One Signature Initiative in 2023, acceptance has been favorable, and we have expanded its footprint by incorporating it into our standard operating procedures. This article discusses our experiences, and ancillary departments’ experiences, with the One Signature Initiative. Our experience is an example of how a One Signature Initiative can be developed that is efficient, effective, and well-accepted by clinical research stakeholders.

There has been an erosion of trust in medical care and clinical research, and this has raised issues about whether institutions and investigators conducting clinical research are worthy of trust. We review recent literature on research on trust and trustworthiness in the clinical research enterprise and identify opportunities to enhance trustworthiness, which will likely increase participant trust in clinical research. In addition, we review materials reporting the results of national polls related to the public’s trust in different occupations. The literature on trustworthiness and trust is complex and suffers from a lack of agreement on definitions of trust and trustworthiness and actions to enhance trustworthiness. Nonetheless, institutions need to take action to address the many elements that contribute to being perceived as trustworthy. As a complementary approach, since nurses have consistently ranked highest on trust by the public for twenty-two straight years, we analyze the features that likely account for the public’s uniform high regard for nurses. We propose specific actions to enhance the role of research nurses in the research enterprise, without compromising their primary role as participant advocates, that we have adopted at Rockefeller University to gain the benefits of the public’s trust in nurses in building trustworthiness.

Involving participants in the design of clinical trials should improve the overall success of a study. For this to occur, streamlined mechanisms are needed to connect the populations potentially impacted by a given study or health topic with research teams in order to inform trial design in a meaningful and timely manner. To address this need, we developed an innovative mechanism called the “ResearchMatch Expert Advice Tool” that quickly obtains volunteer perspectives from populations with specific health conditions or lived experiences using the national recruitment registry, ResearchMatch. This tool does not ask volunteers to participate in the trial but allows for wider community feedback to be gathered and translated into actionable recommendations used to inform the study’s design. We describe early use cases that shaped the current Expert Advice Tool workflow, how results from this tool were incorporated and implemented by studies, and feedback from volunteers and study teams regarding the tool’s usefulness. Additionally, we present a set of lessons learned during the development of the Expert Advice Tool that can be used by other recruitment registries seeking to obtain volunteer feedback on study design and operations.

Clinical research studies run the risk of being in a deficit leading to premature study termination or a desperate struggle to find new funding to continue the research. It is important for institutions, small or large, to have financial oversight during the research process. We created a financial audit process for a core clinical research department at a pediatric hospital. Understanding where to find your costs, what costs are important, and other elements of the audit process are essential. Knowing how to replicate a financial audit process can help you eliminate the risk of a financial deficit.

Although highly involved in heart failure (HF) patients’ care, home care workers (HCWs) lack HF training and are poorly integrated into the healthcare team. For its potential to address these challenges, we examined the role of technology among HCWs caring for HF patients. We conducted 38 interviews with key stakeholders. Overall, four themes emerged. Participants reported that technology is critical for HF care, but existing systems are outdated and ineffective. HCWs also have limited access to electronic resources. Technology, training, and principles of implementation science can be leveraged to improve HCWs’ experience in caring for HF patients and home healthcare delivery.

Academic health sciences libraries (“libraries”) offer services that span the entire research lifecycle, positioning them as natural partners in advancing clinical and translational science. Many libraries enjoy active and productive collaborations with Clinical and Translational Science Award (CTSA) Program hubs and other translational initiatives like the IDeA Clinical & Translational Research Network. This article explores areas of potential partnership between libraries and Translational Science Hubs (TSH), highlighting areas where libraries can support the CTSA Program’s five functional areas outlined in the Notice of Funding Opportunity. It serves as a primer for TSH and libraries to explore potential collaborations, demonstrating how libraries can connect researchers to services and resources that support the information needs of TSH.

The ACT Network was funded by NIH to provide investigators from across the Clinical and Translational Science Award (CTSA) Consortium the ability to directly query national federated electronic health record (EHR) data for cohort discovery and feasibility assessment of multi-site studies. NIH refunded the program for expanded research application to become “Evolve to Next-Gen ACT” (ENACT). In parallel, the US Food and Drug Administration has been evaluating the use of real-world data (RWD), including EHR data, as sources of real-world evidence (RWE) for its regulatory decisions involving drug and biological products. Using insights from implementation science, six lessons learned from ACT for developing and sustaining RWD/RWE infrastructures and networks across the CTSA Consortium are presented in order to inform ENACT’s development from the outset. Lessons include intentional institutional relationship management, end-user engagement, beta-testing, and customer-driven adaptation. The ENACT team is also conducting customer discovery interviews with CTSA hub and investigators using Innovation-Corps@NCATS (I-Corps™) methodology for biomedical entrepreneurs to uncover unmet RWD needs. Possible ENACT value proposition hypotheses are presented by stage of research. Developing evidence about methods for sustaining academically derived data infrastructures and support can advance the science of translation and support our nation’s RWD/RWE research capacity.

This study investigates practicing clinician and staff perspectives on potential protocol modifications for the “Nasal Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis” (NOSES) study, a pragmatic randomized controlled trial aiming at improving acute rhinosinusitis management. Focus groups with clinicians and staff at the pretrial stage recommended expanding participant age inclusion criteria, incorporating patients with COVID-19, and shortening the supportive care phase. Participants also discussed patient engagement and recruitment strategies. These practical insights contribute to optimizing the NOSES trial design and underscore the value of qualitative inquiries and healthcare stakeholder engagement in informing clinical trial design.

The obesity epidemic has continued to rise at an alarming rate and has increased health complications in children, adolescents, and adults. Resistance training, aerobic training, and a combination of the two have been shown to be effective at reducing excess adiposity and improving outcomes of obesity. The continued development of programs, community centers, or medical exercise facilities prescribing these treatments is nearing an absolute necessity to slow the advancing nature of obesity and related metabolic diseases. In this brief review, we summarize the effectiveness of these three training paradigms from a population-centric perspective.

SPARCRequest© (Services, Pricing, & Application for Research Centers) is a web-based research management system that provides a modular and adaptable “electronic storefront” for research-related services. Developed by the South Carolina Clinical & Translational Research Institute at the Medical University of South Carolina, it was released as open source (OS) code in 2014. The adoption of SPARCRequest© accelerated in 2016, when, to ensure responsiveness to the needs of partners, its governance also became open. This governance model enables OS partners to suggest and prioritize features for new releases. As a result, the software code has become more modularized and can be easily customized to meet the diverse needs of adopting hubs. This article describes innovative aspects of the OS governance model, including a multi-institutional committee structure to set strategic vision, make operational decisions, and develop technical solutions; a virtual roadmap that ensures transparency and aligns adopters with release-based goals; and a business process model that provides a robust voting mechanism for prioritizing new features while also enabling fast-paced bug fixes. OS software evolves best in open governance environments. OS governance has made SPARCRequest© more responsive to user needs, attracted more adopters, and increased the proportion of code contributed by adopters.

The Colorado Immersion Training in Community Engagement (CIT) program supports a change in the research trajectory of junior faculty, early career researchers, and doctoral students toward Community-Based Participatory Research (CBPR). CIT is within the Community Engagement and Health Equity Core (CEHE) at the Colorado Clinical and Translational Sciences Institute (CCTSI), an NIH-funded Clinical and Translational Science award. This Translational Science Case Study reports on CIT’s impacts from 2010 to 2019. A team from The Evaluation Center at the University of Colorado Denver utilized four primary data sources: administrative records, participant written reflections, participant and Community Research Liaison (CRL) interviews, and community partner surveys. Data were analyzed using the framework of CBPR principles and the conceptual logic model. CIT trained 122 researchers in CBPR through embedded education within various Colorado communities. CIT Alumni secured ∼$8,723,000 in funding between CCTSI Pilot Grants and external funding. Also, CIT alumni implemented CBPR into curricula and community programming and developed deep, lasting relationships. Further key learnings include the crucial role of CRLs in building relationships between university and community partners and how CIT may serve as a mechanism to improve historical mistrust between communities and universities.

Well-being is a multifaceted construct that is used across disciplines to portray a state of wellness, health, and happiness. While aspects of well-being seem universal, how it is depicted in the literature has substantial variation. The aim of this scoping review was to identify conceptual and operational definitions of well-being within the field of occupational health. Broad search terms were used related to well-being and scale/assessment. Inclusion criteria were (1) peer-reviewed articles, (2) published in English, (3) included a measure of well-being in the methods and results section of the article, and (4) empirical paper. The searches resulted in 4394 articles, 3733 articles were excluded by reading the abstract, 661 articles received a full review, and 273 articles were excluded after a full review, leaving 388 articles that met our inclusion criteria and were used to extract well-being assessment information. Many studies did not define well-being or link their conceptual definition to the operational assessment tool being used. There were 158 assessments of well-being represented across studies. Results highlight the lack of a consistent definitions of well-being and standardized measurements.

The National Institutes of Health requires data and safety monitoring boards (DSMBs) for all phase III clinical trials. The National Heart, Lung and Blood Institute requires DSMBs for all clinical trials involving more than one site and those involving cooperative agreements and contracts. These policies have resulted in the establishment of DSMBs for many implementation trials, with little consideration regarding the appropriateness of DSMBs and/or key adaptations needed by DSMBs to monitor data quality and participant safety. In this perspective, we review the unique features of implementation trials and reflect on key questions regarding the justification for DSMBs and their potential role and monitoring targets within implementation trials.