Pre-Conference Workshop Registration Form

Whether an attendee is new to negotiating budgets or have been doing it

for years, budgets can be daunting - each budget is different and they are ever-changing. What

shouldn’t change is how a site handles them so it’s time to standardize the budget review process.

During this session, attendees will learn how to determine costs at a site then maintain, track, and

update those costs while implementing a plan to use what they’ve developed. We also discuss how

to review a protocol to uncover hidden costs that can then be factored into budgets so costs are

covered. At the end, I summarize everything discussed and how what I cover affects overhead,

payment terms, screen fails, unscheduled visits, justification documents, etc.

This interactive workshop addresses a critical question in clinical research:

how can monitoring strategies designed to accelerate timelines impact overall study quality,

oversight, and audit readiness—and how can teams effectively respond?

Using a real-world case study from a large, multi-site investigational device trial enrolling over 35,000 participants, this workshop will guide participants through the evolution of monitoring strategies implemented to resolve source data verification (SDV) backlog and meet interim analysis

timelines. Participants will explore how intensive approaches—including rapid scaling of monitoring

resources, hybrid monitoring models, and SDV-only monitoring visits—can introduce unintended

risks to monitoring effectiveness, data integrity, and regulatory compliance.

Through a combination of facilitated discussion and hands-on group exercises, participants will actively engage in identifying operational and regulatory risks across multiple levels of study execution, including CRA performance, site engagement, data management, and oversight processes. Participants will work collaboratively to perform root cause analysis and develop

corrective and preventive action (CAPA) strategies based on realistic study scenarios.

The workshop will introduce a structured monitoring effectiveness framework that integrates risk-based monitoring principles, communication pathways, and sustainable resourcing strategies.

Participants will apply this framework to both the case study and their own clinical trial environments, enabling direct translation of workshop content into practice.

As the lead presenter and Clinical Lead on this study, I will facilitate discussion, guide interactive exercises, and provide practical insights into monitoring strategy development, risk identification, and implementation of mitigation approaches. Emphasis will be placed on balancing operational

efficiency with comprehensive oversight to ensure data integrity and audit readiness.

Participants will leave with practical tools, including a monitoring effectiveness framework, risk identification checklist, and CAPA development approach, which can be immediately applied to

improve monitoring effectiveness and study execution in complex clinical trials.

Clinical Trial Data Management: From Data to Decision is a practical, end-to-end intensive workshop designed to demystify the complex journey of clinical evidence. This course bridges the gap between bedside clinical care and database integrity, equipping participants

with the essential skills to transform patient interactions into high-quality, publishable data.

Participants will explore the full clinical data lifecycle, starting with how study protocols define measures and moving through the design of Case Report Forms (CRFs) that reduce human error.

The curriculum traces each data point from the initial source document to the final database lock, culminating in the translation of raw data into the tables and figures required for professional

publication.

The workshop also reinforces key principles of Good Clinical Practice (GCP) and data integrity standards, empowering participants to confidently support inspections, regulatory submissions, and data-driven decision-making in clinical trials.

 This workshop provides a practical, high-impact introduction to project management within clinical research. Participants will learn how to effectively plan, initiate, and execute clinical trials using proven project management principles tailored to real-world site, CRO, and sponsor environments. Key topics include study startup and planning, stakeholder

communication, timelines and milestones, risk identification and mitigation, and oversight of vendors and trial activities.

Through interactive examples and applied exercises, learners will leave with actionable tools and frameworks they can immediately use to improve efficiency, reduce delays, and support successful trial delivery.

Clinical Research Pro is a Premier Authorized Training Partner with the Project Management Institute (PMI). This training can be used for maintenance of PMP certification with PMI-approved

PDUs.

 Quality management is a critical component of clinical trial operations. Effectively incorporating quality by design (QbD) practices into research elevates the operational

proficiently, compliance with the governing requirements, and protection of the participants. This pre-conference, which incorporates the QbD strategies emphasized by the newly published ICH GCP E6 (R3), will illustrate the foundational components of quality management systems and focus on how to build and maintain a strategically designed quality assurance program.

Abby will cover the incorporation of QbD into clinical research, practical approaches, and the shift

from R2 to R3.

Alyssa will cover the fundamentals of Quality Management and discuss best practices that support highly effective quality programs.

Preparing initial and continuing submissions to the Institutional Review

Boards (IRBs) and designing a high-quality informed consent process remain central to protecting individuals who participate in human research. While many clinical research professionals understand the foundational regulations, they often need deeper, practice oriented skills to work effectively with IRBs and to develop consent materials that meet regulatory expectations and support participant comprehension.

This intermediate level session will strengthen participants’ ability to apply FDA regulations and ICH Good Clinical Practice (GCP) standards in real world research settings. Through case studies, scenarios and lessons learned, participants will gain strategies around these essential topics, including: effective processes to ensure protocol and consent compliance, submitting reportable

IRB items and addressing root causes for non-compliance, designing an education forward informed consent process to ensure participant understanding, enhancing clarity and effectiveness of consent materials, and highlighting how IRBs evaluate consent documents specifically, to assess

risk. The session is designed to move research professionals beyond compliance basics and build the operational confidence needed to collaborate successfully with IRBs to support ethical, participant centered research.

This 4-hour interactive hands-on workshop is designed for research sites

seeking to leverage artificial intelligence (AI) to streamline administrative tasks, develop protocol-based checklists, set up regulatory binders, and enhance overall study management.

Participants will learn from the speakers' collective experience with practical AI tools and strategies, focusing on real-world applications to improve efficiency and compliance in clinical research operations.

This workshop is for those who are involved in the registration, management, and results entry of studies in the Protocol Registration and Results System (PRS).

The session will review PRS Administrator responsibilities, lessons learned from moving an existing program toward a positive direction, and provide guidance for managing trials, in addition to how to assist teams with the registration and results entry process. Best practices and helpful tips for both

Administrators and users will be provided. Attendees are invited to bring their own scenarios for group discussion and should leave the workshop with skills to successfully manage trials within ClinicalTrials.gov

This preconference workshop will guide attendees through the complete process of designing and implementing a comprehensive Principal Investigator (PI) Bootcamp.

Attendees will explore how to build an effective program structure, develop an implementation plan, and create educational content that strengthens the core competencies PIs need to lead high‑performing, compliant research teams.

Designed as an immersive train‑the‑trainer experience, the session not only outlines the essential components required for a successful PI Bootcamp but also demonstrates adaptable curriculum materials grounded in Good Clinical Practice (GCP) guidelines, regulatory requirements, and

real‑world clinical trial experience. Attendees will examine practical teaching strategies, key learning objectives, and sample modules that can be tailored to the needs of their own institutions or organizations.

Throughout the workshop, attendees will engage with hands‑on materials, interactive demonstrations, and practical planning exercises that reinforce both understanding and application.

Attendees will leave with actionable resources and tools, customizable educational content aligned with GCP and regulatory practices, templates and resources and a structured roadmap to launch or enhance their own PI Bootcamps within their own institutions or organizations.