2021 Full Program Replay

Jan 12, 2021 ‐ Sep 30, 2021



Products

CRRC: Clinical Research Revenue Cycle Management: Avoiding the Pitfalls

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CRRC: Clinical Research Revenue Cycle Management: Avoiding the Pitfalls

May 27, 2021 12:15pm ‐ May 27, 2021 1:30pm

Organizations that participate in clinical research activities face a complex and highly regulated industry. For Clinical Research Departments, understanding the regulatory compliance risks associated with clinical research is essential for everyone– including executive management (c-suite) to avoid significant non-compliance penalties from the federal and state governments. Discover how implementing a Proactive Compliance concept to a CRRC program is the most advantageous way of addressing regulatory matters for an institution.

Speaker(s):
  • Mary Veazie, BS, MBA, Executive Director, Clinical Research Finance, UT MD Anderson Cancer Center
  • Erika Stevens, BA, MA, Principal Consultant, Recherche Transformation Rapide

techXpo Session -- How to Build Advanced Workflows with an Integrated Technology Environment

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techXpo Session -- How to Build Advanced Workflows with an Integrated Technology Environment

May 27, 2021 1:30pm ‐ May 27, 2021 2:30pm

No one wants to work across twenty systems, remember one hundred passwords, or duplicate work between different software packages. But far too often, this is the result when disparate technology solutions are adopted at research sites and an integration strategy is not put in place. In this engaging session, you'll learn how to harness the power of best-in-class software while avoiding digital fatigue, duplication, and wasted time. What do you do to make sure integrated workflows are part of the system from day one? Which processes or workflows should you tackle first? How do you work with sponsors to reduce technology overload while still getting the benefits of advanced solutions? We'll answer these questions and let you in on the secrets other organizations are using to build the integrated research site of the future.

NOTE: This session does NOT offer ACRP Contact Hours.

Speaker(s):

Truly Integrating Research Administration – Best Practices

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Truly Integrating Research Administration – Best Practices

May 27, 2021 2:45pm ‐ May 27, 2021 3:50pm

Funding for research continues to constrict, successful organizations must continuously improve, innovate and advance. Integration of research administration functions from grants and contracts, clinical operations, to regulatory oversight through IRB/IACUC/IBC is crucial to ensure your programs are organized and working together to support research. And integration doesn’t always mean new technology, most improvements can be implemented with people and programs.

In this session, we will share success stories and provide practical tips on how to accomplish better integration in your research program.

Speaker(s):
  • James Riddle, BA, CRQM, CPIA, CIP, Vice President Research Services & Strategic Consulting, Advarra

CDER BIMO Compliance and Enforcement – What You Need to Know!

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CDER BIMO Compliance and Enforcement – What You Need to Know!

Sep 16, 2021 11:00am ‐ Sep 16, 2021 12:00pm

Explore key opportunities for the clinical research industry to make the FDA inspection experience a positive one. Hear inspections' impact on applications and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.

Speaker(s):
  • David Burrow, PharmD, JD, Director of the Office of Scientific Investigations (OSI), Center for Drug Evaluation and Research, FDA

Knock Knock...The FDA Is Here

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Knock Knock...The FDA Is Here

Sep 16, 2021 12:15pm ‐ Sep 16, 2021 1:15pm

Explore what it takes to be ready for the figurative knock on the door from FDA. Examine FDA Inspections and how to prepare for the inevitable knock, discuss available resources, and review responses received from 483s.

Speaker(s):
  • Eric Pittman, MBA, Program Division Director, U.S. Food and Drug Administration

techXpo Session -- Achieving Regulatory Compliance via Collaboration: Technology and Site Perspectives

Preview Available

techXpo Session -- Achieving Regulatory Compliance via Collaboration: Technology and Site Perspectives

Sep 16, 2021 1:30pm ‐ Sep 16, 2021 2:30pm

Meeting regulatory compliance requirements can be strenuous and drain a site’s resources. This session shows that achieving regulatory compliance is primarily a collaborative exercise, involving coordination and partnership between multiple roles and stakeholders, sites as well as their technology solution providers. In the changing landscape of research, sites can reduce compliance risks and achieve new efficiencies by using a comprehensive and unified research management ecosystem including electronic paper binders, EDC, remote patient engagement and data monitoring capabilities.

This session is presented by WCG Velos and the University of Kansas Medical Center.

NOTE: This session does NOT offer ACRP Contact Hours.

Speaker(s):
  • Sonia Abrol, VP, Product Strategy, WCG Velos
  • Dinesh Pal Mudaranthakam, Director of Research Information Technology/Co-Director of Investigator Initiated Trials (I.I.T), University of Kansas Medical Center

Best Practices for Handling Consent Withdrawals

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Best Practices for Handling Consent Withdrawals

Sep 16, 2021 2:45pm ‐ Sep 16, 2021 3:45pm

The first right of the patient after consenting to participate in a trial is the right to withdraw this consent. However, a consent withdrawal may have several forms and consequences, and understanding the underlying reasons behind a consent withdrawal may affect the steps to be implemented for a proper follow-up and return to routine practice.

This session will bring communication keys to site personnel to properly interact with patients willing to opt out from a trial, taking into consideration safety aspects, protocol compliance and data protection aspects.

Speaker(s):

The Art of Having a Strategic Advantage in Compliance Conflict Management

Preview Available

The Art of Having a Strategic Advantage in Compliance Conflict Management

Sep 23, 2021 11:00am ‐ Sep 23, 2021 12:00pm

This session has been a longstanding session at ACRP that primarily reviews new laws and regulations passed (or pending passage) that generally are not intended to directly govern the clinical research industry but certainly will have direct or indirect impact as well as intended or unintended consequences.

Speaker(s):
  • Kelly Willenberg, BSN, MBA, DBA, Owner of Kelly Willenberg, LLC, Kelly Willenberg & Associates
  • Dawn Pittinger, MBA, CHRC, CRCP, Research Billing Compliance Manager, Moffitt Cancer Center

FDA's Oversight of ClinicalTrials.gov Requirements

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FDA's Oversight of ClinicalTrials.gov Requirements

Sep 23, 2021 12:15pm ‐ Sep 23, 2021 1:15pm

This session will describe the definitions and requirements for clinical trial registration and submission of results requirements to ClinicalTrials.gov. This session will also describe FDA's role in the compliance and enforcement of ClinicalTrials.gov, as well as a review of available FDA resources for those involved in ClinicalTrials.gov clinical trials.

Speaker(s):
  • Miah Jung, PharmD, Pharmacologist, Center for Drug Evaluation and Research, FDA
  • Jan Hewett, B.S.N., J.D., Regulatory Counsel (Policy), Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA

techXpo Session -- Working with Site-Based Paperless Solutions and Ensuring Audit Readiness

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techXpo Session -- Working with Site-Based Paperless Solutions and Ensuring Audit Readiness

Sep 23, 2021 1:30pm ‐ Sep 23, 2021 2:30pm

An overview of site-based electronic systems that the research industry is rapidly adopting brought to you by RealTime Software Solutions.

NOTE: This session does NOT offer ACRP Contact Hours.

Speaker(s):
  • Rick Greenfield, BBA-IS, CEO, RealTime Clinical Trial Management Systems
  • Nathan Levens, Director of Virtual Solutions & Technology, RealTime Clinical Trial Management Systems