Study Design and Conduct

Overview

Syllabus 9

1. Clinical Research Concepts: Questions, Hypotheses, and Objectives 35 minutes

   This module teaches you how broad clinical problems are translated into measurable research questions, testable hypotheses, and specific study objectives. You'll annotate a set of provided research questions in Microsoft Word to identify how each component is framed in a sample clinical study. Unde…

2. Clinical Research Concepts: Observational vs. Interventional Approaches 1 hour

   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 appro…

3. Research Methodologies: Elements of Study Design 35 minutes

   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 pr…

4. Research Methodologies: Analyzing Protocol Alignment 1 hour

   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…

5. Research Ethics: Foundational Principles 35 minutes

   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 M…

6. Research Ethics: Recognizing Ethical Risks 1 hour

   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.…

7. Good Clinical Practices: Purpose and Principles 35 minutes

   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…

8. Good Clinical Practices: Applying GCP to Routine Tasks 1 hour

   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 t…

9. Project Module: Study Design & GCP Compliance Framework 1 hour

   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 d…

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Taught by

• Microsoft