Semester 1
Module A: General Principles of Clinical Trials (15 ECTS)
Module overview
Introduction to the clinical trial lifecycle: phases and trial classification, study design, research questions, endpoints, randomization, blinding, bias, eligibility criteria, and feasibility. Site selection and activation, informed consent process and documentation, multidisciplinary patient and study management (investigator, nurse, psychologist, sponsor, coordinator), sampling, investigational product accountability and destruction, laboratory workflows, endpoints and adaptive designs. Contemporary topics include AI and data-driven research, digital and decentralized trials, new therapies, Declaration of Helsinki, pharmacokinetics/pharmacodynamics, Phase IV studies, quality of life, and pharmacoeconomics/cost assessment. Includes on-site clinical training and practical data management skills.
Module aims
To provide a strong theoretical and applied foundation in the planning, conduct, and evaluation of clinical trials across all phases, with emphasis on scientific design, ethics and compliance, multidisciplinary operations, and hands-on experience through on-site training.
Module B: Good Clinical Practice & Regulatory Framework (15 ECTS)
Module overview
Good Clinical Practice (GCP) principles, ethics committees, participant rights, and conduct of clinical trials under EU and Greek legislation. Submissions and approvals (Ethics Committees and National Competent Authority), regulatory requirements, GDPR and DPO role, quality systems (ISO, SOPs, calibration). Inspections (national/EU), common findings and corrective actions, protocol compliance, CRF, good documentation practices, data management, site training, auditing, and CRA roles (I–IV). Pharmacovigilance and safety reporting (AE/SAE, DSUR), central study management, monitoring, and data handling. Includes on-site clinical training and practical data management skills.
Module aims
To develop advanced understanding and practical competence in GCP and regulatory compliance, preparing students to operate confidently within audited/inspected environments and to manage safety, documentation, monitoring, and quality systems in clinical research.
Semester 2
Module C: Research Methodology I (15 ECTS)
Module overview
Core epidemiology and biostatistics for clinical research: descriptive and analytical epidemiology, incidence/prevalence, confounding, mortality indicators, relative and attributable risk. Data collection and analysis, databases, descriptive and inferential statistics, association and regression, sample size calculation, analysis of clinical trials, diagnostic accuracy, real-world data, and predictive models. Scientific writing and interpretation of trial results, systematic reviews and meta-analyses, basics of translational research, biotechnological medicines and biosimilars. Includes practical training using analysis software and an applied group exercise in systematic review/meta-analysis.
Module aims
To build robust skills in research design, statistical reasoning, critical appraisal, and evidence synthesis, enabling students to analyze and interpret clinical research outputs and contribute to publications.
Module D: Research Methodology II (15 ECTS)
Module overview
Translational application of evidence: implementation of findings, sustainability and cost considerations, nocebo, real-world evidence and public impact, regulatory outcomes (approvals/recalls). Experimental research concepts: animal models, experimental design, root cause analysis, research in crisis settings (e.g., pandemics), biomarkers, basket and umbrella trials. Cross-cutting competencies: medical writing and presentations, introductory bioinformatics, big data, and patient engagement through structured discussions.
Module aims
To connect research outputs with clinical practice, policy, and regulation, while strengthening modern skills required for translational research, communication, and responsible, patient-aware decision-making.
Semester 3
Module E: Master’s Thesis & Optional Internship (30 ECTS total)
Students complete the Master’s Thesis in the third semester. Two pathways are available:
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Thesis only (30 ECTS): Minimum 75 pages for a literature review/systematic review, or no fixed length for a meta-analysis or original research project intended for publication.
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Thesis (20 ECTS) + Optional Internship (10 ECTS): Minimum 50 pages for a literature review/systematic review, or no fixed length for a meta-analysis or original research intended for publication.
Optional internship
A two-month, full-time internship in organizations involved in the design and conduct of clinical trials, under the supervision/collaboration of the assigned academic supervisor. The internship is optional and awards 10 ECTS.