LEADMe Final Presentation: School-Central Unit Effort to Educate on Clinical Trial Processes Discuss my role: Currently, industry contract officer in the industry-funded research group Previously, contract officer responsible for clinical trial agreements Mentee: Angie Karchmer, J.D. Industry Contract Officer Institute for Innovation

The Project Goal: Explain internal process for industry-funded clinical trials start to finish with all component parts Audience: Anyone in the chain This presentation is meant to give a bird’s eye view of the clinical trial agreement process, such that each player in the process understands the roles of the other players and why certain information and deadlines are required. The part of the presentation on the contract process is one that a contract officer can give to any or all of the individual players as well as helping to train new contract officers. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ POINTS BELOW OPTIONAL: TOO MUCH SPECIFIC INFORMATION ABOUT THE PROJECT (1) The contract process presentation starts with an overview of the basics (What is a clinical trial agreement? What is an industry sponsor? Why do clinical trial agreements come to my office? Why do PIs still have to sign CTAs?) (2) I then discuss the minimum required documents needed to trigger my review of the clinical trial agreement. This includes a brief overview of our school’s electronic routing system that we use for proposals, Kuali Coeus. I explain what the required documents are and why they are necessary. (3) I next discuss how the negotiation of the clinical trial agreement fits in with the other internal processes, which are budget negotiation and regulatory approvals, including IRB and conflict of interest committees. (4) I explain the other internal approval needed, which is the project approval that is captured by the Kuali Coues proposal system, before the PI and I can sign the agreement. (5) Finally, I talk about the actual award set up in our internal award system.

Joint Presentation with the School of Medicine Execution: Developed “The Clinical Trial Approval Process at UC Irvine” presentation jointly with the School of Medicine

Study Team IRB School of Medicine SPA CRFA Explaining the process and having stakeholder understanding is vital. The overall process involves multiple parties and layers, with concurrent reviews and approvals: The study team, comprised of the principal investigator, co-investigators, clinical research coordinators, research nurses, department administrators are the center of the wheel, driving all the other processes (regulatory approvals, financial approvals, contract approvals) Negotiation of the budget Coverage analysis by the clinical research billing department of the university hospital The IRB approval Capturing the internal project approval by the principal investigator, department chair and school dean’s office Negotiation of the clinical trial agreement by the sponsored projects administration office Conflict of interest approval (if relevant)

Status Update on the Project Two presentations to department administrators (responsible for pre-award and post-award financial management), clinical research coordinators and research nurses in conjunction with the School of Medicine The clinical research coordinators and research nurses are the boots on the ground with respect to the actual management of the trial once it’s underway. They were just as eager to learn about these processes as the department administrators.

How the Project Encompasses the Five Successful Practices of Leadership Using the Five Practices: Model the way Inspire a shared vision Challenge the process Enable others Encourage the heart With the goal of: promoting education and transparency to streamline processes and building multi-unit cohesion and efficiency It’s a laborious process to get a clinical trial started, with work from so many units and people to finally make it happen.

1. Model the Way Making my process transparent to open a dialog about every unit’s process The presentation models the way because I am broadcasting to the campus community what my duties and responsibilities are. In some ways, and understandably so, central offices can seem like a black hole because the campus doesn’t understand exactly what we do or why we do it. By putting my duties and obligations out there with specificity, I am allowing myself to be held accountable. But open dialog about the entire process gets other stakeholders, including department contacts and clinical research coordinators, to think about cementing their processes as well.

2. Inspire a Shared Vision Becoming quicker in starting trials will make us a more attractive site for sponsors, potentially increasing clinical trial participation My hope is that while capturing in one document the overall view of our internal processes required for a clinical trial, the project helps to inspire a shared vision by helping the stakeholders understand the entire process. A shared understanding of all the cogs in the wheel could culminate in quicker, and ultimately more efficient turn arounds and initiations of trials. With the nature of some trials (competitive enrollments for sponsor-authored studies), making the bureaucratic process more streamlined because of a coordinated effort of all the moving parts is a desired outcome because it can make the university a more attractive potential site for future studies and will help improve our reputation as a site – a vision of not only the school of medicine but also shared by our new chancellor, who wants to increase the overall research activity of the university.

3. Challenge the Process Objective analysis of each unit’s process, especially through the presentation of the entire process to spark conversation about improvements This exercise, especially in working with the school of medicine dean’s office, allows for the central, school and department units to have a discourse about the process, which encourages new ideas and more innovative ways to accomplish required ends. We can have coherent discussions about best practices for clinical trials funded by sponsors other than industry sponsors, which further strengthens the clinical trial enterprise as a whole. We can have a constructive conversation about challenging related processes.

4. Enable Others Pulling back the curtain gives stakeholders a tool to challenge all processes – are there steps we can enhance? Clear communication gets us all on the same page By providing a presentation that helps better inform all players in the process, I also hope to enable others to act by giving us all the tools we need to question our current processes and see if there are ways of collaborating and improving how we do things to simplify the process even more. With the whole picture in front of us, can we come up with better ways of doing this? Can this become a tool to challenge the process of each stakeholder and see if there’s something we can improve?

5. Encourage the Heart Dialog and education creates a spirit of community Breaks down siloes My presentation, incorporated into the school of medicine’s presentation, is a great opportunity to encourage the heart. As we discuss the entire process with department contacts, budget negotiators and clinical research coordinators, we can create a spirit of community. We can foster a culture of team work, by showing that we are not siloed, disparate units but all important members of a giant team with the ultimate goal of improving patient care. Face to face presentations can also help develop relationships among the different units, instead of only knowing someone by email and phone.

LEADMe Program: Lessons Learned About my Leadership Abilities Clear communication is key Make people feel like they are part of a team Never stop learning You don’t have to be a manager to be a leader

Finally: Giving Back to NCURA I hope to graduate from this program and become a Mentor-In-Training I will continue service in my regional volunteer committee I would like to present at every NCURA conference I attend

Thank you! Thank you to my Mentor, Rashonda Harris; the LEADMe Chair, Derick Jones; and another Mentor, Heather Kubinec!

Questions? Contact me! angie.karchmer@uci.edu 949-824-0341