Clinical Trials Overview Intensive

This three-week immersive training program provides a comprehensive and practical understanding of conducting clinical trials. Designed for professionals involved in investigator-initiated research (IIR) and industry or government-sponsored research, this program equips participants with specialized knowledge to navigate, collaborate, and engage effectively in multiple clinical trial environments. Through a structured curriculum, participants will explore clinical trial frameworks, regulatory compliance, and operational strategies essential for successful clinical trial execution.

Covering the full clinical trial cycle—from protocol development and study initiation and regulatory approvals to data management, patient recruitment, financial/contract structures, and ethical considerations—this program blends expert-led discussions, case studies, and hands-on exercises to ensure practical application. Participants will earn 12 CEU credits and gain access to five additional hours of on-demand webinars, reinforcing key concepts. Ultimately, this program is designed to enhance effectiveness in clinical trials, supporting new drugs, devices or other interventions designed to improve patient care and population health outcomes.

Winter Session

Type:	Online
Date:	February 2 – 23, 2026 (excluding February 16) Mondays & Wednesdays, 1:00 – 3:00 PM ET

Learning Objectives

By the end of this program, attendees will be able to...

Identify the relevant regulations and agency guidance to ensure compliant and ethical conduct of clinical trials.
Describe methods and techniques to improve clinical trial operations.
Master the tools to improve efficiency and compliance in clinical trials.

Intended Audience

The Clinical Trials Overview Intensive training is for clinical research administrators, principal investigators, departmental, and center professionals who are interested in learning how to successfully conduct clinical trials.

Course Details

This intensive program was developed to give a unique insight into clinical trials in multiple environments.

Key Topics Include:

Regulatory and Ethical Frameworks – Compliance with FDA, Common Rule, ICH-GCP, and HIPAA regulations.
Clinical Trials Lifecycle – From protocol development to active trial management and closeout procedures.
Study Designs & Research Modalities – Including interventional and observational trials.
Study Sponsorship – Industry, government, or institutional.
Financial & Contractual Considerations – Budgeting, contract negotiation, and financial feasibility of clinical trials.

This expert-led training is ideal for clinical research professionals, clinical investigators, healthcare administrators, IRB staff, Clinical Research Organization (CRO) staff, and industry sponsors seeking in-depth knowledge of clinical trials. Participants will leave with the tools to optimize trials, ensure regulatory compliance, and enhance the impact of clinical trials.

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Register for the Session

This three-week immersive program offers a comprehensive, practical overview of the full clinical trial lifecycle, equipping professionals in investigator-initiated and sponsored research with the knowledge needed to navigate and support diverse clinical trial environments. Participants will earn 12 CEU credits, gain access to five hours of on-demand webinars, and build the skills necessary to contribute effectively to high-quality clinical trials that advance patient care and population health.

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