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Background: The study startup process for interventional clinical trials is a complex process that involves the efforts of many different teams. Each team is responsible for their startup checklist in which they verify that the necessary tasks are done before a study can move on to the next team. This regulatory process provides quality assurance and is vital for ensuring patient safety [10]. However, without having this startup process centralized and optimized, study approval can take longer than necessary as time is lost when it passes through many different hands. Objective: This manuscript highlights the process and the systems that were developed at The University of Kansas Comprehensive Cancer Center regarding the study startup process. To facilitate this process the regulatory management, site development, cancer center administration, and the Biostatistics & Informatics Shared Resources (BISR) teams came together to build a platform aimed at streamlining the startup process and providing a transparent view of where a study is in the startup process. Process: Ensuring the guidelines are clearly articulated for the review criteria of each of the three review boards, i.e., Disease Working Group (DWG), Executive Resourcing Committee (ERC), and Protocol Review and Monitoring Committee (PRMC) along with a system that can track every step and its history throughout the review process. Results: Well-defined processes and tracking methodologies have allowed the operations teams to track each study closely and ensure the 90-day and 120-day deadlines are met, this allows the operational team to dynamically prioritize their work daily. It also provides Principal investigators a transparent view of where their study stands within the study startup process and allows them to prepare for the next steps accordingly. Conclusion/future work: The current process and technology deployment has been a significant improvement to expedite the review process and minimize study startup delays. There are still a few opportunities to fine-tune the study startup process; an example of which includes automatically informing the operational managers or the study teams to act upon deadlines regarding study review rather than the current manual communication process which involves them looking it up in the system which can add delays.

Abstract Background Despite increasing support for stakeholder inclusion in research, there is limited evaluative research to guide safe (i.e., youth‐friendly) and meaningful (i.e., non‐tokenistic) partnerships with young people with lived experience of mental ill‐health in research. This paper describes a pilot evaluation and iterative design of a Youth Lived Experience Working Group (LEWG) protocol that was established by the Youth Mental Health and Technology team at The University of Sydney's Brain and Mind Centre, based on the results of two studies. Methods Study one consisted of a pilot evaluation of the extent to which youth partners felt empowered to contribute, to qualitatively explore how LEWG processes could be improved. Youth partners completed online surveys, and results were shared over two LEWG meetings in 2021 to empower youth partners to collectively identify actions of positive change regarding LEWG processes. These meetings were audio‐recorded and transcripts were subsequently coded using thematic analysis. Study two assessed whether LEWG processes and proposed improvements were acceptable and feasible from the perspective of academic researchers via an online survey in 2022. Results Quantitative and qualitative data collected from nine youth partners and 42 academic researchers uncovered initial learnings regarding facilitators, motivators, and barriers to partnering with young people with lived experience in research. Implementing clear processes for youth partners and academic researchers on effective partnership strategies, providing training opportunities for youth partners to develop research skills, and providing regular updates on how youth partner contributions led to research outcomes were identified as key facilitators. Conclusions This pilot study provides insight into a growing international field on how to optimise participatory processes so that researchers and young people with lived experience can be better supported and engaged to make meaningful contributions to mental health research. We argue that more transparency is needed around participatory research processes so that partnerships with young people with lived experience are not merely tokenistic. Consumer Contributions Our study has also been approved by and reflects the concepts and priorities of our youth lived experience partners and lived experience researchers, all of whom are authors of this paper.