Maximize your Annual Conference experience by adding a SOCRA Pre-Conference Workshop to your registration. These focused, expert-led sessions offer an opportunity to dive deeper into timely topics, build practical skills, and engage in meaningful discussion with peers before the conference begins.
Each workshop is eligible for 4 Continuing Education (CE) credits, providing exceptional value while helping you advance your knowledge and professional development.
Register for a Preconference Workshop here!
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.
Laura Adkins, MAP, CCRP, CCRA, AdvCRS, University of Arkansas for Medical Sciences, Director of the Office of Research Regulatory Affairs
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 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.
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.
Alyssa Gateman, MPH, CCRP, Yale Cancer Center, Executive Director, Clinical Trials Office
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.
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 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.
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.
Culture, Career, Calling: The Blueprint for the Clinical Research Professional is designed to support career development through intentional self-discovery, guided conversation, and practical planning.
This pre-conference workshop helps participants navigate the clinical research career path by exploring how purpose and organizational culture shape professional decisions, growth opportunities, and long-term direction.
Through facilitated reflection and shared experiences, attendees will clarify what drives them, identify the skills and experiences they want to build next, and leave with a personalized career blueprint they can use to stay engaged, make informed choices, and contribute meaningfully to the field’s broader mission.
Register for a Preconference Workshop here!