Generalizable Solutions

Develop innovations that address persistent challenges to advancing translational progress that are found across multiple research initiatives or projects, or span research on multiple diseases or conditions.

Example approaches:

• Across Multiple Projects or Initiatives: Advance research by identifying, developing and/or testing solutions to common bottlenecks or roadblocks that have stymied multiple projects. These may be scientific, operational, or administrative in nature.
• Across Diseases or Conditions: Approach research challenges and develop solutions by seeking commonalities across research projects on a range of diseases or conditions.
• Organizational Environment: Enable development and testing of generalizable solutions through organizational policies, organizational structure, and shared resources.

Auditing of a Clinical Research Site

This module provides a detailed understanding of the auditing process in clinical research and how it ensures compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. Learners are introduced to the distinctions between monitoring, auditing, and inspection, as well as the purpose, scope, and procedures that define an effective audit. The course outlines auditor qualifications, essential steps before, during, and after an audit, and the documentation required for evaluation, including regulatory binders and investigator credentials.

2026

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Introduction to Clinical and Translational Research Study Design

This course is designed for residents, fellows, faculty, and staff as a practical introduction to clinical and translational research methods. Held every other week between August and December, the course includes a combination of asynchronous videos, didactic lectures, discussions, and practical applications.

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Monitoring of a Clinical Trial Site

This module introduces the fundamental principles and practices involved in monitoring clinical trial sites. It covers definitions and types of clinical trials, the application of Good Clinical Practices, and the roles and responsibilities of sponsors, investigators, and institutional review boards. Learners will review essential documentation processes and quality functions such as data capture, quality control, and assurance. The module also explains the purpose and scope of trial monitoring, including the qualifications and responsibilities of monitors, data standards like ALCOA + CCEA, and the different types of monitoring activities.

2026

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Regulatory Science Symposium: Product Development in a Digital World

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Seminar Series

The Seminar Series is an educational initiative that supports clinical and translational researchers through expert-led sessions focused on innovation, collaboration, and career development. Covering topics from scientific communication to regulatory science and team leadership, the series equips researchers with the tools and knowledge to accelerate the translation of discoveries into real-world health solutions.

Self Paced/Ongoing

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Site Preparedness for FDA Inspection

This module provides an overview of the FDA inspection process and the steps sites should take to ensure continuous readiness. Learners will explore the similarities and differences between audits and inspections, the key stages of an inspection, and the circumstances that may prompt an FDA site visit. The course emphasizes the importance of mock inspections as a tool to evaluate compliance and identify areas for improvement before an official inspection occurs.

2026

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