Investigator Oversight of External Parties (ICH GCP E6 R2): Compliance Tips and Tools for Sites!

Apr 23, 2022 3:30pm ‐ Apr 23, 2022 4:30pm
Expiration Date: May 30, 2024

Identification: 5057

Credits: None available.

Investigators/institutions might need to hire an external party (physician specialist, or laboratory, EKG facility) to execute a clinical trial. Regulatory authority inspections have noted that the Investigator/Institution's lack of systematic, and comprehensive assessments prior to trial start and during the clinical trial has impacted both participant safety and reliability of the data generated by the Investigator. Get the insight and tools needed to: Evaluate current organizational practices against industry practices for selection and oversight of external parties by the Investigator; Distinguish industry practices, procedures and tools needed for both external party selection and oversight; and Construct the framework for effective and compliance external party oversight program.

Signature Series: Fostering Diversity and Inclusion in Clinical Research

Apr 24, 2022 7:00am ‐ Apr 24, 2022 8:00am
Expiration Date: May 30, 2024

Identification: 5058

Credits: None available.

Developing diversity in clinical trials in both the workforce and the patient participants has been a topic of interest for some time. Join our panel as they discuss interesting study results and current initiatives to help put action into increasing diversity in clinical research. Bringing different perspectives and sharing stories of their own perspectives of how we can move forward in developing a more diverse workforce and patient demographic within clinical trials is what they are excited to share with you.

CRA Manager Role as an Inquiring Leader

Apr 24, 2022 9:15am ‐ Apr 24, 2022 10:15am
Expiration Date: May 30, 2024

Identification: 128

Credits: None available.

This session is brought to you by a generous educational grant, courtesy of Bracane Company: Being a CRA Manager in 2022 requires flexibility, inquiry, and love for your team. When CRAs leave a company, they are often leaving their manager. A CRA Manager hugely impacts the CRAs work experience. Make sure if your CRA leaves, its because you helped them grow into a new role within your company. In this session we will review: Effective One on Ones versus Status Updates, Helping Your People Grow and then Grow More, Enough Feedback - (Hint: They want it more often.), Effective Feedback/Feedforward, Organizing Your Day Like a Leader, Identifying Quality Risks and Understanding Performance Gaps, Onboarding for Success -- CRA Mentors
Learning Objectives:
  • The learner will distinguish the quality impact of a one on one using inquiry versus status updates.
  • The learner can learn to inventory CRA experience and desired growth to begin the next career journey.
  • The learner will identify strategies for feedback that have a coaching feel versus a manager feel.

Culture of Quality: From Concept to Implementation

Apr 24, 2022 9:15am ‐ Apr 24, 2022 10:15am
Expiration Date: May 30, 2024

Identification: 131

Credits: None available.

Today, most pharmaceutical companies, as a business practice, have communicated their culture of quality via their Quality Policy which aligns the purpose and strategic direction of the organization. Frequently, this policy also lays the framework for quality objectives and states the commitment to meeting requirements (patient, regulatory, customer, ISO, etc.) as well as a pledge to work toward continual improvement.ICH E8(R1) General Considerations for Clinical Research has codified this industry practice (e.g., Quality Policy) by requiring sponsors to “Create a culture that values and rewards critical thinking and open dialogue about quality and that goes beyond sole reliance on tools and checklists”.In this session, presenters will share a phased approach for assessing, implementing, and monitoring an organization’s evolving culture of quality to align with the ICH E8(R1) requirements. Assessment and monitoring tools that have been successfully applied in clinical research will be presented.The presenters will also discuss a critical thinking framework that provides a systematic approach for decision making and at the simplest level consists of the 4 As: Ask, Analyze, Answer, and Act. These components have been mapped along a cultural-maturity model based (e.g., specific behaviors and expected team member skills). The presenters will share a real case study that illustrates how the critical thinking enabler was implemented with a clinical research study team.
Learning Objectives:
  • Develop a phased approach for assessing, implementing and monitoring a culture of quality
  • Explain the critical thinking framework
  • Apply the critical thinking framework

Honey, I Blew Up the Research Study - How to Come Back from a Bad Study

Apr 24, 2022 9:15am ‐ Apr 24, 2022 10:15am
Expiration Date: May 30, 2024

Identification: 125

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:
  • Identify a mistake or series of problems in a study
  • Create a Corrective and Preventive Action Plan
  • Understand how to move the study forward

It Takes Two: Sponsor/Protege Relationships in Clinical Trials

Apr 24, 2022 9:15am ‐ Apr 24, 2022 10:15am
Expiration Date: May 30, 2024

Identification: 176

Credits: None available.

Virginia Nido and Julia Medina will co-present on our personal experience cultivating asponsor/protégé relationship over many years. Virginia is an executive director at Genentech and Julia is an administrative assistant, aspiring to be a clinical research associate. We will discuss how and why we started and are committed to continuing a sponsor/protégé relationship, the advantages and challenges we have faced, and our responsibilities to each other.

Learning Objectives:
  • Participants will understand the differences between and advantages of mentor/mentee relationships and sponsor/protégé relationships.
  • Participants will learn from empirical research how sponsoring benefits both the sponsor and protégé.
  • Participants will develop a practical action plan towards finding a sponsor or becoming a sponsor.

techXpo hosted by Advarra: Connecting Research Site and Sponsors Through an Integrated Technology Ecosystem

Apr 24, 2022 9:15am ‐ Apr 24, 2022 10:00am
Expiration Date: May 30, 2024

Identification: 5028

Credits: None available.

In this session, Stuart Cotter, Director of Product Management at Advarra, will outline challenges faced by sites who are overburdened with sponsor-driven technology, resulting in duplicative efforts, longer timelines, and reduced patient focus. He will share progress made by a new consortium of sites, sponsors, and CROs to address this problem, working together to connect existing site technology to sponsor systems seamlessly. Stuart will also provide actionable insight for attendees to take advantage of this connected ecosystem, empowering site stakeholders to drive efficiencies across their clinical trial lifecycle.
Learning Objectives:
  • Understand the research site burden created by sponsor-mandated technology and review current and past efforts to alleviate these challenges
  • Explore how site-centric technology will provide the foundation for a more efficient, effective path to site/sponsor data exchange
  • Learn about current efforts and progress toward developing data standards to be leveraged by sites, sponsors, and CROs

The Feasibility Intake Process: Managing and Implementing an Institutional Feasibility Process that Aligns with Your Institutional Needs

Apr 24, 2022 9:15am ‐ Apr 24, 2022 11:15am
Expiration Date: May 30, 2024

Identification: 106

Credits: None available.

This session will address the challenge around how to implement a centralized feasibility process and assess a study protocol and know whether or not your institution should participate in the study. This is important for the audience to learn because assessing a feasibility process is essential and the last thing someone wants to do is agree to participate in a study that does not align with their institution's values or would not be a successful study for their site to participate in. The audience will walk away with tools needed to implement a centralized feasibility process.

Learning Objectives:
  • Understand the importance of a centralized feasibility process
  • How to assess which studies to participate in and when to say no, thank you
  • Apply these tools for implementation at your institution

Is Your Research Site Ready for Human Gene Therapy Research?

Apr 24, 2022 10:30am ‐ Apr 24, 2022 11:30am
Expiration Date: May 30, 2024

Identification: 116

Credits: None available.

The world has been introduced to mRNA and was surprisingly comfortable with genetically engineered treatments. Gene therapy based products are entering human trials at an exponential growth rate. Is your institution ready to participate? In this session we will take a look at the basics of conducting human gene therapy research, requirements for Institutional Biosafety Committee review as outlined in NIH Office of Science Policy guidelines, and prepare you and your institution to be ready when the next human gene therapy trials comes along.
Learning Objectives:
  • Understand the basic regulations and guidelines governing IBCs and gene therapy research
  • Learn key takeaways to prepare your research organization to participate in this growing field of research
  • Explain the role of the IBC and where their oversight is different than IRB

techXpo hosted by Reify Health: Reducing Site Burden for Oncology Trials

Apr 24, 2022 10:30am ‐ Apr 24, 2022 11:15am
Expiration Date: May 30, 2024

Identification: 5029

Credits: None available.