12:00 - 1:00 PM ET Registration and Lunch
1:00 - 2:00 PM ET Site Operational Models: Decentralized vs. Centralized Clinical Trial Services
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
Ms. Benson will discuss the benefits and limitations of centralized and decentralized management models of conducting clinical trials.
2:00 - 2:45 PM ET Opportunities Abound - The Clinical Research Career Pathway
Jessica Fritter, MACPR, ACRP-CP, Faculty, Clinical Instructor of Practice, The Ohio State University, College of Nursing
Ms. Fritter will focus on providing you an overview of the multiple career pathways in clinical research. Many fall into this career, but how do we educate people on clinical research as a career option and then where you can go once in the profession. Attendees will walk away with skills they can apply to help market themselves for future job opportunities.
2:45 - 3:00 PM ET Break
3:00 - 4:00 PM ET Building and Leading High Performing Teams
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Ms. Wentzel will discuss strategies for finding and retaining the talented people needed for the ever changing field of clinical research.
4:00 - 5:00 PM ET Measuring Site Performance
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Ms. Wentzel will identify key performance indicators in clinical research and offer suggestions for how/why sites should measure them and how they can be used to justify additional resources.
8:00 - 8:30 AM ET Registration and Continental Breakfast
8:30 - 9:00 AM ET Welcome & Introduction
Program Co-Chairs:
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
9:00 - 10:00 AM ET Ethics in Pediatric Research
Mona Khurana, MD, Pediatric Team Leader, Division of Pediatric and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic and
Reproductive Medicine, Office of New Drugs, US Food and Drug Administration
This session will provide insight into the complex ethical considerations when conducting clinical research in the pediatric population.
10:00 - 10:15 AM ET Break
10:15 - 11:00 AM ET Kids vs. Adults in Clinical Trials: Improving Access and Engagement for Families
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Ms. Wentzel will discuss ways in which sites can improve engagement for families by defining tactics to educate and promote research participation.
11:00 AM - 12:30 PM ET Practical Guidelines for Writing Research Informed Consent and Assent Documents
David Staley, MA, Director, Clinical Research Quality Assurance and Regulatory Support, Seattle Children's Hospital
Simplicity, clarity, and brevity are the best criteria for writing research informed consent and assent documents. Participants in this workshop will identify guidelines to capture the goals of this criteria. From there, they will use the guidelines and create a checklist to assess whether passages from informed consent and assent documents are simple, clear, and brief. Then, participants will apply the guidelines and their checklist to write clear, inviting, and meaningful sections of a consent or assent document.
12:30 - 1:15 PM ET Lunch
1:15 - 2:00 PM ET Tales of a Pediatric Nurse
Kandice Roush, BSN, RN, CCRC, Clinical Research Nurse & Team Leader, Nationwide Children’s Hospital
Ms. Roush will discuss ways a research nurse can review a protocol for feasibility and help to set reasonable expectations for the potential patient population. She will explore tips to promote protocol adherence with pediatric trials and the lengths that pediatric nurses will go to in order to get study visits and procedures completed.
2:00 - 2:45 PM ET Pediatric Drug Development: The Process, Regulations, Ecosystem and Horizon
Mary A. Short, RN, MSN, Pediatric Research Consultant
Ms. Short will discuss the pediatric drug development process from an industry perspective. She will discuss how the regulations and the ecosystem impact the development of pediatric therapeutics and potential approaches to accelerate development.
2:45 - 3:00 PM ET Break
3:00 - 4:00 PM ET Setting Up Your Study for Success
Jessica Fritter, MACPR, ACRP-CP, Faculty, Clinical Instructor of Practice, The Ohio State University, College of Nursing
When tasked with starting a new study, it can feel overwhelming. Where do you begin? Ms. Fritter will break down the startup process that will help ensure study success. She will discuss how to adequately review the protocol and source documents, list the documentation needed, discuss how to identify obstacles that may occur and the importance of communication amongst the study teams. Attendees will leave this session feeling prepared with their very own checklist.
4:00 - 5:00 PM ET Round Table Discussions
8:00 - 8:30 AM ET Continental Breakfast
8:30 - 10:00 AM ET Budgeting and Contracting for Pediatric Clinical Trials
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
Ms. Benson will discuss special considerations for developing pediatric clinical trial budgets including a review of "hidden costs" that tend to be overlooked in the pediatric population. She will also discuss strategies for contract negotiations and timely payment collection
10:00 - 10:15 AM ET Break
10:15 – 11:00 AM ET Workshop- Let’s Develop a Pediatric Clinical Trial Budget
Lisa Benson, BS, CRCP, President, Pediatric Clinical Research Consulting, LLC
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Ms. Benson and Ms. Wentzel will provide a hands on approach for participants to develop a study budget. Participants will be given a mock protocol, tools and budget template to review.
11:00 - 11:45 AM ET Managing AE’s, Con Meds and SAE’s in Kids
Kandice Roush, BSN, RN, CCRC, Clinical Research Nurse & Team Leader, Nationwide Children’s Hospital
Ms. Roush will review the various ways for data capturing and follow up for AEs, conmeds and SAE’s and reporting requirements to institutional review boards. She will discuss the role and importance for external monitoring and methods safety issues are identified and managed during drug development and post marketing of new medications.
11:45 AM - 12:30 PM ET Lunch
12:30 - 1:30 PM ET Developing a Peer Review QA System
Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
This session will discuss the compliance challenges associated with conducting clinical trials and one site’s strategy to address this challenge.
1:30 - 2:30 PM ET Industry Sponsored Research: What Sites Should Know
Mary A. Short, RN, MSN, Pediatric Research Consultant
Ms. Short will provide attendees with an overview of what sponsors look for when selecting sites for pediatric clinical trials. She will review the potential role of pediatric clinical research networks in accelerating the development of pediatric therapeutics.
2:30 - 2:45 PM ET Break
2:45 - 3:45 PM ET Round Table Discussions
3:45 - 4:30 PM ET The Future of Pediatric Clinical Trials-Gene Therapy
Course Faculty
This session will provide conference attendees with a glimpse into where pediatric is headed in the next decade.
4:30 - 4:45 PM ET Wrap Up and Questions