ACRP 2020 Part 1 - Study Management & Conduct - Part 1 On Demand

May 14, 2020 ‐ May 14, 2020



Products

Implementation of a Feasibility Vetting Committee at the Department Level: Selecting the Right Trials

Preview Available

Implementation of a Feasibility Vetting Committee at the Department Level: Selecting the Right Trials

May 14, 2020 11:00am ‐ May 14, 2020 12:00pm

The field of clinical research is evolving at an exponential pace and sites need to be ready to take on trials they are able to handle, conduct compliantly, and successfully recruit into. At the forefront of any clinical trial is the betterment of the patient by offering life-saving or life-prolonging therapies. In addition to patient impact sites also understand academic impact and aligning projects with their scientific mission and vision. Behind the scenes of any trial is the clinical research operations team who must assess if the project is doable given the time and resources required. This session will look at the employment of a vetting feasibility tool within a formal research committee review process and outline whether or not this tool was predictive of successful participation in clinical trials.

Learning Objectives:

  • Understand the importance of a research vetting committee
  • Understand the research vetting committee's role in a successful clinical research program
  • Utilize the feasibility tool to evaluate sample studies to understand how the tool works and may benefit your program

Speaker(s):
  • Alyssa Stucke, Senior Clinical Research Coordinator, MedStar Georgetown Transplant Institute

Study Startup Innovation

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Study Startup Innovation

May 14, 2020 1:00pm ‐ May 14, 2020 2:00pm

Study Startup Innovation for any research organization that includes: - Startup models that allow for quick activation upon patient identification - Technology approaches that solve for visibility of the startup process - Best practices that eliminate operational barriers to opening a trial.

Learning Objectives:

  • Convey how technology and other approaches can save your research organization financially and operationally
  • Understand why startup timelines are so impactful to the overall health of your research program
  • Implement practical best practices that reduce barriers to opening a trial

Speaker(s):

Investigator Site File's (ISF) - Developing, Implementing, and Maintaining a Site Standard

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Investigator Site File's (ISF) - Developing, Implementing, and Maintaining a Site Standard

May 14, 2020 2:15pm ‐ May 14, 2020 3:15pm

This presentation includes the importance of quality file management at the site level via Investigator Site File(ISF) standards. The importance of this presentation is to illustrate standardization in large site file management practices as well as assurance for regulatory compliance. The audience will walk away with practical knowledge on the importance of a solid ISF standardization process as well as how to implement into their sites or improve current state of ISF management. The presentation will include a case observation from of a newly implemented ISF process at Children's Mercy Hospital.

Learning Objectives:

  • Aknowledge the importance and implement a quality site wide Investigator Site File (ISF) process.
  • Inspection/Regulatory Rediness
  • Standardization of file maintenance

Speaker(s):
  • Trevor Cole, BHS, MBA-HCM, CCRC, Research Quality Monitoring Program Manager, Children's Mercy Hospital

Leveraging Data to Drive Decision Making - Financial Focus

Preview Available

Leveraging Data to Drive Decision Making - Financial Focus

May 14, 2020 3:30pm ‐ May 14, 2020 4:30pm

Data is a powerful analytical tool that can be analyzed to drive decision-making and utilized to improve performance. Organizations with clinical research portfolios should leverage data and recognize the importance of harnessing the power of data analytics. These organizations should learn to leverage today’s smart informatic technology and effectively use data analytics to create discovery platforms, which are used to make academic content more readily available through electronic systems so it can be shared with organizations and their collaborating partners. This allows information to become more transparent and, in turn, fosters a culture of innovation. This session will focus on guiding attendees through key data analytics like metrics and key performance indicators and leveraging them at their organizations.

Learning Objectives:

  • Develop metrics to help an organization become savvier with utilizing resources
  • Discuss how data can direct strategies for an organization
  • Leverage data to mitigate the financial risks associated with their clinical research

Speaker(s):
  • Mary Veazie, BS, MBA, Executive Director, Clinical Research Finance, UT MD Anderson Cancer Center