Failure to understand and implement a comprehensive research billing compliance program can result in monetary penalties, close scrutiny from the U.S. Department of Health and Human Services' Office of Inspector General, and loss of reputation to a research institution. Institutions participating in clinical trials must understand the risks. Additionally, they need the knowledge and skills to accurately perform coverage analysis and manage charges based on that analysis. Finally, institutions need tools for conducting internal audits to ensure all processes are followed correctly. In this master class, participants will learn the “why” of having a comprehensive clinical research billing compliance program and can practice their coverage analysis and auditing skills through hands-on activities.

CEU: 1.00 ACRP

Speaker:

• Shanna Ford, MHA, Research Office Senior Associate, Huron Consulting Group

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Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.

An electronic data capture (EDC) system is software that’s used to electronically collect, manage, store, and export data for the clinical investigations which are critical to support safety and effectiveness claims for drugs, devices, and diagnostic tests. Most EDC systems can be customized to ensure data collection matches the product performance criteria, population characteristics, and statistical analysis plan for a product regulatory submission. This session will describe best practices and pitfalls to avoid when ensuring an EDC system is fit for each unique clinical investigation purpose. Let’s talk about the dos and don'ts and the collaborative sponsor/site/contract research organization approach to EDC validation to make sure we have a clean dataset with the most automated efficiencies and data mapping to scientific endpoints to achieve EDC that's fit for purpose every time.

CEU: 1.00 ACRP

Speaker:

• Patricia Smith, Senior Clinical Data Manager, NAMSA

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.

It seems as if everyone has their own way of designing case report forms (CRFs). For study coordinators, this can mean encountering new expectations (good, bad, or indifferent) from study to study, as well as the same things (truly necessary or not) across many studies. There's always a bit of copying and pasting happening, too, in the hope that lessons learned from prior studies will guide the development of future CRF content. But what if you could have a fail-proof process to ensure that the first draft of a CRF had 95% of the critical variables needed? Find out how using a statistics-driven approach can simplify CRF design. Cut out the noise by removing onerous and non-applicable checklist variables and focusing on only adding analyzable fields that make every single variable useful. During this talk, a research coordinator-turned-clinical research associate will also provide insight into how they contribute to the review process to ensure study flow at the site is taken into consideration.

CEU: 1.00 ACRP

Speakers:

• Anna Rillo, BSN, RN, Study Director, Bright Research

• Robin Solinsky, BS, VP, Technology & Innovation, Bright Research

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The session will focus on various types of protocol designs and changes, with an emphasis on adaptive designs. We will review the FDA guidance on “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Taking a deeper dive into unplanned design changes and regulatory considerations, we will engage in one of the oldest thought experiments in Western philosophy, the Ship of Theseus, to address an ambiguity in clinical trial design. Here, we will consider alternative ways protocols are commonly modified, and whether those changes could be considered an entirely new clinical trial, rather than a modification. This session will also provide an educational background in trial design for professionals who haven't had as much exposure to the topic as they wish, and will include a detailed review of sections of ICH E8(R1) and ICH E6(R2), where they relate to trial design.

CEU: 1.00 ACRP

Speaker:

• Amanda Egan, Associate Clinical Research Associate, Merck

Watch a Sneak Peek into the Session Content:

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.

This session will review the ways in which critical representatives, including patient and caregiver advocates, from across the research landscape can be meaningfully engaged by sponsors and sites to co-develop effective, patient-facing processes or resources. Through the lens of an ongoing community-engaged project, steps and strategies to recruit, engage with, and retain key informants will be presented and discussed. Participants will come away with an appreciation of the opportunities that sustained relationship-building affords a project, as well as tips and techniques for including patients and community members from initiation through dissemination, and beyond. Topics to be covered include health literacy concepts, clear communication strategies, and workgroup facilitation techniques.

CEU: 1.00 ACRP

Speaker:

• Sylvia Baedorf Kassis, MPH, Program Director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Data form the cornerstone of efforts to address health disparities and advance health equity across the globe. In the United States, Medicare and Medicaid collect and publicly disclose race, ethnicity, and socio-economic characteristics to address health disparities and identify underserved communities. In Europe, healthcare systems and policies vary significantly across countries. While some European countries collect similar data as in the U.S., other countries collect and share no or only limited data due to concerns about discrimination, individual privacy, or historical sensitivities. Despite the limitations, there is still a broad range of high-quality data which can be consolidated, standardized, and visualized to support streamlined diversity and site identification strategies. We’ll take a deep dive into the hurdles and complexities of diversity data collection and the efforts needed for standardization of data, explore the potential barriers and factors that explain the gaps in current data strategies, and discuss data-driven approaches for more diverse clinical research.

CEU: 1.00 ACRP

Speaker:

• Elke Ydens, Associate Director of Business Solutions, Anju Software

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National strategic policy in England is to expand the diversity of clinical trial participants, bringing research opportunities to communities most in need. Our hospital has worked to commission wide-ranging dataset visualizations, to pinpoint which specific areas of the country have the greatest disease burden, and so may be prime candidates for clinical trial site selection. We have integrated assessment of cancer incidence, prevalence, and mortality--in addition to demographic data--to create a data-driven approach to site identification and selection, rather than using more traditional performance metrics or simply prior experience and relationships. We aim for an England where no cancer patient is left behind without access to research, and where our clinical trials recruit rapidly to time and target whilst bringing immediate patient benefit to those most in need.

CEU: 1.00 ACRP

Speaker:

• Mark Brandon-Grove, Head of Clinical Research Performance & Quality, The Royal Marsden NHS Foundation Trust

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The overall focus and goal of the session is to support attendees’ knowledge and skills on the key elements for building a successful investigator-initiated clinical trial protocol, with a specific focus on developing clinical trials in oncology. Participants will gain an understanding of how to effectively move research ideas from the bench to the bedside, beginning with the design of a feasibility assessment and feasibility review. The development of early protocol documents that are used to secure study drugs/devices and funding will be discussed, along with the planning strategies necessary for making the protocol as comprehensive and inclusive as possible (e.g., choosing entry criteria to enhance diversity and inclusiveness will be discussed).

CEU: 1.00 ACRP

Speaker:

• Kimberly Bullock, PhD, CCRP, Director, Protocol Development Team and Associate Professor of Research, University of Virginia

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