ACRP 2022

Apr 23, 2022 ‐ Apr 25, 2022



Sessions

Signature Series: Celebrating YOU!

Apr 23, 2022 8:00am ‐ Apr 23, 2022 9:00am
Expiration Date: May 31, 2024

Identification: 5056

Credits: None available.

This session welcomes our ACRP Research Community to our Annual Conference, with overarching themes of gratitude and ideas for the future. Join us as we thank our members and everyone throughout the clinical research community for their commitment to excellence in clinical research and their dedication and contribution to improving health outcomes for all. ACRP’s Executive Director will present an update of the key advancements across ACRP, the Association’s evolution of educational offerings, and ACRP’s vision for the future. Special guests will share thanks and hope for the future.

Speaker(s):

Positive Outcomes in Building a QMS: A Case Study

Apr 23, 2022 10:15am ‐ Apr 23, 2022 11:15am
Expiration Date: May 31, 2024

Identification: 117

Credits: None available.

FDA presenters have been forwarding the concept of conducting clinical research from a Quality Management System (QMS) approach for over 15 years. With the release of the ICH E6(R2) GCP guideline and the topic coming up at multiple conference venues, researchers are starting to take notice and recognize the importance of using such a methodology. In this case study, an established clinical research site chose to adapt a QMS approach. They started their journey by assigning the sites Manager to attend outside training on the topic. Following that, they identified external QMS experts to assist them in the process. A gap assessment on their existing processes was performed. Recommendations were taken into consideration and, as appropriate, were adopted by the site. All site staff were trained in the principles of a QMS approach, and related procedures and processes were developed. The new system was launched, and at this time the site is fine tuning their processes and procedures in order to extract the most benefit from the approach. The presentation will discuss difficulties encountered along the way and the positive outcomes realized from conducting and instituting the process. Future activities to ensure maintenance of the approach are currently being determined, assessed and will be implemented as applicable to the site’s experience and learnings. The presentation’s primary goal is to demonstrate how any site can approach instituting a QMS approach within their organizations.

Learning Objectives:
  • Describe the primary components of a QMS
  • List the challenges in developing a QMS approach at a site setting
  • List the positive outcomes of sites using a QMS approach for the conduct of regulated clinical research
Speaker(s):

Strategies for Effective Communication: Establishing the Foundation

Apr 23, 2022 10:15am ‐ Apr 23, 2022 11:15am
Expiration Date: May 31, 2024

Identification: 124

Credits: None available.

This session describes communication methods, explores leading solutions for miscommunication, identifies steps for messaging alignment with competing directives and analyzes effective modalities to share information across multiple stakeholders in the clinical research enterprise. Organizational communication requires an understanding of urgency, impact, and cadence of the intended messaging. Understanding the context of the targeted recipients, the business communication needs and the channels for information, impacts communication effectiveness. Clinical research programs are frequently impacted by inaccurate and ineffective communication. Critical to the success or failure of communication is timeliness and mode of execution. Leveraging proven steps for effective communication include conducting a communication needs assessment, implementing communication laddering, applying the rule of nine and establishing communication plans. Analyzing lessons learned, leading practices and implementation methods via case study will be addressed in this session.

Learning Objectives:
  • Describe and identify leading practices for effective communication in clinical research
  • Examine and review communication models for meeting various clinical research audiences
  • Evaluate and analyze implementation approaches for managing multiple stakeholder complexities impacting communication
Speaker(s):
  • Erika Stevens, BA, MA, Principal Consultant, Recherche Transformation Rapide
  • Mary Veazie, BS, MBA, Executive Director, Clinical Research Finance, UT MD Anderson Cancer Center

Risk Management: From Framework to Implementation

Apr 23, 2022 10:15am ‐ Apr 23, 2022 12:15pm
Expiration Date: May 31, 2024

Identification: 132

Credits: None available.

In 2016, ICH E6(R2) stated that “the quality management system should use a risk-based approach with the following: critical process and data identification, risk identification, risk evaluation, risk control, risk communication, risk review and risk reporting.” Six years later, clinical trial execution has become even more complex - scientifically, technologically, and environmentally, and with complexity has come increased risk to quality (patient safety, rights and well-being and data fit for purpose, absent of errors that matter for decision-making) that must be controlled. Today, many organizations are still grappling with establishing a systematic approach for identifying and managing risks that come with the execution and oversight of clinical trials. But building a strong risk management plan enables the sponsor to build quality into trial operations. Providing a plan to a health authority inspector, in turn, enables them to assess whether the sponsor proactively identified and controlled clinical trial risks before and during the clinical trial.In this Master Presentation, risk management concepts and implementation approaches will be discussed and practiced. Using hypothetical case studies, participants will have hands-on experiences with designing a proactive approach for the identification and management of risks which meets the expectations of ICH E6(R2). Participants will leave with knowledge and access to materials that will enable the clinical trial-related design and implementation of a risk management plan for a clinical trial.

Learning Objectives:
  • Explain the systematic approach for clinical trial risk management expectations in relation to ICH E6(R2)
  • Apply a risk management framework to develop a risk management plan for a clinical trial
  • Implement a systematic approach for effective execution of clinical trial risk management
Speaker(s):
  • Leslie Sam, Principal Consultant, Risk Management and Issue Management Practice Lead, Wool Consulting Group
  • Mary Brantner, BS, MS, Executive Director, Head of Global Development Operations, Mallinckrodt Pharmaceuticals

Creating a Clinical Research Team with Diverse and Dynamic Roles

Apr 23, 2022 10:15am ‐ Apr 23, 2022 11:15am
Expiration Date: May 31, 2024

Identification: 145

Credits: None available.

In this session, we will explore how to create depth in a Clinical Research Team, a problem which is often faced by Clinical Research sites. Please join Dr. Suzanne Rose as she shares her insight and knowledge on how to create a broad range of research positions on any size clinical research team. In this session, you will learn about best utilizing each team member to their fullest capacity and how to be creative in job sharing and maximizing performance from each team member. Come to this session to learn how to think outside of the box of the typical clinical research team members' defined roles and responsibilities and how to best align your team with your department and organization's goals. In this session, you will have the opportunity to learn about unique job descriptions as well as be provided with justifications for each role. The audience will have full access to job descriptions as well as hiring justifications for these roles as well as tips how to work with your leadership and human resource committee to ensure success in obtaining new hires.

Learning Objectives:
  • Identify which clinical research professionals sites should have on their team to strengthen their business
  • Understand how justify the hiring of new employees to leadership
  • Learn to maximize job performance of each employee by understanding their strengths
Speaker(s):
  • Suzanne Rose, MS, PHD, Director of the Office of Research, Stamford Hospital

Ready…Fire!...Aim. How We Got Through the Pandemic and What’s Next

Apr 23, 2022 10:15am ‐ Apr 23, 2022 11:15am
Expiration Date: May 31, 2024

Identification: 5000

Credits: None available.

Join this exciting overview on how the pandemic forced many into decentralization of the site and the effects of site cash flow, workforce safety and increased flexibility. How can we all (Sponsor/CRO/Site) help each other through these challenges and how we as a workforce can maintain compliance while working in a remote environment.

Learning Objectives:
  • Describe lessons learned through the COVID-19 pandemic
  • Summarize the use of remote monitoring in clinical trials
  • Summarize TEFCA requirements for securely sharing clinical information
Speaker(s):
  • David Vulcano, MBA, LCSW, RAC, CIP, CBP, Vice President, Research Compliance & Integrity, HCA

techXpo hosted by RealTime Clinical Trial Management Systems: Site Tools That Add Value for Study Participants Leading to Improved Retention, Regulatory Compliance and Higher Quality Data

Apr 23, 2022 10:15am ‐ Apr 23, 2022 11:00am
Expiration Date: May 31, 2024

Identification: 5005

Credits: None available.

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

Mission "Possible" - Research Compliance

Apr 23, 2022 11:30am ‐ Apr 23, 2022 12:30pm
Expiration Date: May 31, 2024

Identification: 122

Credits: None available.

Do not allow research compliance risk to be nail biting at your site. Take the steps to analyze your risk, know your portfolio, and always be audit ready. Thwart suspicion and create trustworthiness to ensure compliance and ethics is first and foremost.

Learning Objectives:
  • Evaluate their site risks in research compliance through simple steps
  • Analyze understand enterprise wide whether research is valued as a compliance risk
  • Formulate process and policy with a vetting by the C-Suite
Speaker(s):
  • Kelly Willenberg, BSN, MBA, DBA, Owner of Kelly Willenberg, LLC, Kelly Willenberg & Associates

From CRA to V.P: A Professional Path

Apr 23, 2022 11:30am ‐ Apr 23, 2022 12:30pm
Expiration Date: May 31, 2024

Identification: 123

Credits: None available.

In this session, two key opinion and thought leaders from the clinical research industry will discuss their very distinctive, yet successful career pathways. Careers in clinical research do not sit solely into two baskets, the Clinical Research Coordinator (CRC) or the Clinical Research Associate (CRA). As the clinical research industry continues to evolve, so does the work needed to support these new methods. The skills gained in and throughout varied positions, help pave one’s career pathway. The ability to leverage those experiences and parlay them into the next opportunity is key. Multiple business functions provide exposure to processes throughout the clinical research enterprise and enable a diversified set of skills. Each steppingstone, though it may not seem like a direct route, provides the building blocks for success. Clinical research professionals by design, pay attention to details, follow the rules, and have a common goal to improve health. Identifying steps for navigating career silos and assessing opportunities are proven tools for career growth. Presenters will provide insights on how clinical research professionals can leverage their experience and expertise to impact their careers. Analyzing lessons learned, tips for career development and case studies will be addressed in this session.

Learning Objectives:
  • Describe the various clinical research careers and opportunities for professional development
  • Compare and contrast the clinical research career pathways of the Presidents of two large international research organizations
  • Identify strategies and analyze best practices for creating and sustaining an impactful career in clinical research
Speaker(s):
  • Erika Stevens, BA, MA, Principal Consultant, Recherche Transformation Rapide
  • Quincy Byrdsong, BS, MS, EdD, Vice Provost for Health Affairs, Lipscomb University

techXpo hosted by SLOPE: Operational Overload: Tools to Manage Complexity and Reduce Stress

Apr 23, 2022 11:30am ‐ Apr 23, 2022 12:15pm
Expiration Date: May 31, 2024

Identification: 5004

Credits: None available.

Speaker(s):