This module introduces the people and organizations that make clinical trials happen. You'll learn to identify each stakeholder's role—from sponsors who fund the research to IRBs that protect participants—and create a visual stakeholder map in Microsoft PowerPoint. Knowing who does what in a trial workflow is critical for coordinators who must communicate with multiple parties daily.

This module breaks down how clinical trial phases differ in their objectives, what they measure (endpoints), and who participates. You'll use Microsoft Excel to build a comparison chart that details each phase's characteristics using provided case studies. Being able to quickly distinguish trial phases is a daily requirement for coordinators reviewing protocols and communicating with study teams.

This module introduces the major categories of clinical trial designs and teaches you to classify studies by their purpose. You'll build a classification matrix in Microsoft Excel that organizes trial designs by type, clinical question, and example. Coordinators encounter diverse study types on-site, and recognizing each design's intent helps you understand protocol structure and participant experience.

This module walks through the complete drug development pipeline from target identification and preclinical testing through clinical phases to regulatory approval and post-market monitoring. You'll create a professional flow diagram in Microsoft PowerPoint that maps each stage and its key activities. Understanding this pipeline is essential for coordinators who need to know where their study fits in a product's journey to market.

This module examines how evidence builds across development stages to support regulatory submissions. You'll analyze which safety and efficacy data are generated at each stage and how earlier evidence supports progression to the next. Using Microsoft Word, you'll produce a written report mapping key checkpoints on a sample drug development pathway, a skill that helps coordinators understand why specific data they collect matters for the bigger regulatory picture.

This module compares the device and drug development pathways, highlighting how they differ in intended use, risk classification, iterative design, and the type of clinical evidence required for regulatory clearance or approval. You'll produce a comparative summary in Microsoft Word that demonstrates your understanding of these differences. Coordinators frequently encounter both drug and device protocols, and distinguishing their development logic prevents confusion during study conduct.

This module focuses on the operational tasks unique to device clinical investigations, activities that don't exist in drug trials. You'll learn to identify device accountability procedures, operator training requirements, and performance evaluation methods, then organize them into a structured checklist in Microsoft Excel. Recognizing these device-specific activities prepares you to support device study protocols without overlooking critical operational requirements.