• Michael Mead, PhD, Program Officer, PCORI
• Kim Maschhauser, PhD, Associate Director, PCORI
• Claudia Grossmann, PhD, Associate Director, PCORI

1. Define PCORnet and identify its capabilities.
2. Demonstrate use cases of PCORnet.
3. Develop an understanding of how PCORnet can be used for research and engagement.
4. Understand the PCORI funding opportunities available for use of PCORnet.

• Lauren Cohen, MA, PMP, Associate Director, Duke Clinical Research Institute, Duke University School of Medicine
• Keith Marsolo, PhD, Professor, Department of Population Health Sciences, Duke University School of Medicine
• Rowena Dolor, MD, MHS, Professor, Department of Medicine, Duke University School of Medicine
• Adrian Hernandez, MD, MHS, Vice Dean and Executive Director, Duke Clinical Research Institute, Duke University School of Medicine

In the second half of this two-part series about PCORnet®, members of the Coordinating Center for PCORnet® will build upon part 1 (an overview of PCORnet) by providing a more in-depth review of PCORnet infrastructure resources, including an overview of the PCORnet® Front Door, PCORnet® Common Data Model and stakeholder engagement resources. The presentation will include:

Ways that PCORnet Supports Research:

• Brief Overview
• The PCORnet® Front Door
• PCORnet® Studies and support 

A Deeper Dive Into the Components of the PCORnet® Common Data Model:

• Data quality
• PCORnet® queries 
• Record linkages 

Resources for Stakeholder Engagement:

• Tailored PCORnet® Front Door assistance with recommended engagement activities for study teams based on study design
• Access to engagement tools, education, and training 

By the end of this webinar, participants should be able to: 

1. Understand PCORnet® Studies and their distinctive capabilities 
2. Describe the PCORnet® Common Data Model and Distributed Query Infrastructure
3. Identify resources for stakeholder engagement

• Emily Dressler, PhD, Professor and Interim Chair, Department of Biostatistics and Data Science, Wake Forest University School of Medicine
• Letitia H. Perdue, MS, Senior Manager of Clinical Research, Department of Biostatistics and Data Science, Wake Forest University School of Medicine
• Laura Lovato, MS, Biostatistician, Department of Biostatistics and Data Science, Wake Forest University School of Medicine
• Mark King, Lead Programmer/Analyst, Department of Biostatistics and Data Science, Wake Forest University School of Medicine
• Lindsay Tysinger, Project Manager, Department of Gerontology, Wake Forest University School of Medicine

As is often best recognized in hindsight, the design and content of data collection forms can make or break a clinical trial. During early stages of form development, it is critical to have all parties involved and engaged. From determining what questions to ask, how best to code answers and integrating branching logic, inclusion of investigators, project managers, programmers, biostatisticians, and clinical site staff is crucial every step of the way.

This webinar will take attendees through the forms development process from start to finish, highlighting the perspectives of each of these key stakeholders: investigators, project managers, biostatisticians, programmers and clinic coordinators. Items to be addressed will include: translating trial protocol eligibility, adherence and outcome information into a targeted and concise form; assessing participant burden; understandability to the end user; data validation; developing a form matrix; form versioning; discussion of paper versus electronic forms; staff vs. participant data entry; and evaluating each final form version to assure feasibility of all protocol-specified analyses.

This webinar will give participants an opportunity to expand their understanding of the different design considerations and consequences for form development. The team of presenters represent a cross-section of all disciplines and will demonstrate how this multi-disciplinary approach can work within a typical clinical trial. This model has been successfully implemented in many multi-site projects around the world, including refinement of best practices after receiving and integrating suggestions from clinical staff throughout the globe.

By the end of this webinar, participants should be able to:

1. Understand the importance of including all stakeholders at the beginning of the form development process.
2. Identify how the flow and wording of data collection forms can impact the data collected.
3. Discuss the pros and cons of a variety of data collection methods.