This module teaches you to distinguish between observational and interventional study approaches by analyzing how investigator involvement and data collection intent differ between them. You'll build a side-by-side comparison table in Microsoft Excel using real study examples to classify each approach's characteristics. Coordinators frequently work across study types, and recognizing these fundamental distinctions affects how you manage participants, collect data, and interpret protocol requirements.

This module introduces the core methodology elements that compose a clinical study design—endpoints, variables, eligibility criteria, and visit schedules—and teaches you to differentiate their roles. You'll organize these elements into a structured diagram in Microsoft Excel using a sample study protocol. Coordinators reference these elements daily when screening participants, scheduling visits, and collecting data, making fluency in methodology language essential for effective protocol execution.

This module teaches you to critically evaluate whether a study's chosen endpoint and data-collection approach actually align with its stated objective. You'll review a sample protocol summary in Microsoft Word and provide structured written feedback on alignment strengths and gaps. This analytical skill helps coordinators identify potential protocol issues early and contribute meaningfully to feasibility discussions and protocol amendment conversations.

This module introduces the three foundational ethical principles from the Belmont Report—respect for persons, beneficence, and justice—and explains how they apply to recruitment, consent, confidentiality, and fair participant treatment. You'll complete a structured ethics presentation template in Microsoft PowerPoint that connects each principle to coordinator actions. Understanding these principles is essential because they form the ethical basis for every interaction coordinators have with study participants.

This module teaches you to recognize the common ethical risks that arise in clinical studies—situations that may compromise participant autonomy or welfare. You will review a clinical trial case study in Microsoft Word and identify potential ethical risks using a structured documentation template. Coordinators are often the first to notice these risks in practice, and recognizing them quickly enables appropriate escalation to the principal investigator (PI) or the Institutional Review Board (IRB) before harm occurs.

This module explains why GCP exists, what it protects, and how its principles create a universal standard for clinical trial conduct. You'll complete a structured GCP summary template in Microsoft Word that explains how GCP applies to a simulated study environment. Understanding GCP's purpose gives you the "why" behind every procedure you'll follow as a coordinator from documentation standards to participant interactions.

This module teaches you to apply GCP principles directly to the routine tasks coordinators perform: checking protocol compliance, ensuring source document accuracy, and documenting activities contemporaneously. You'll use a GCP compliance checklist in Microsoft Excel during a simulated site visit to verify adherence to GCP practices. This is where GCP moves from knowledge to action; the skills you practice here will serve as the foundation for your daily operating standards in all future clinical research operations.

This project integrates research framing, methodology analysis, ethics assessment, and GCP verification into a cohesive study design and compliance framework for a simulated Phase II immunotherapy trial. You'll produce a research framework annotation, methodology alignment assessment, ethics risk documentation, and GCP compliance checklist using Microsoft Word and Excel. Demonstrating study design and conduct literacy during a site qualification visit is how coordinators prove their team can execute a protocol correctly—not just logistically, but intellectually.