Compulsory modules
C1: General Principles of Clinical Research
- Overview of main clinical study designs
- Structure of a research protocol
- Descriptive statistics, data visualisation, and introduction to R/RStudio
- Research integrity and ethical principles
- Introduction to patient and public engagement
C2: Cross-sectional Studies, Questionnaire Design and REDCap Databases
- Cross-sectional and ecological study designs
- Questionnaire design
- Setting up a study database in REDCap
- Bias and confounding
- Confidence intervals, and p-values
- Statistical tests (group comparisons), correlation, and measures of association
- Sample size calculations
C3: Cohort Studies
- Introduction to cohort study design, including different types of cohorts
- Designing your own clinical cohort study
- Registries, data linkage, and biobanks
- Introduction to causal inference and directed acyclic graphs (DAGs)
- Simple and multiple linear regression
C4: Funding Research and Science Communication
- How to write a scientific paper
- How to respond to reviewers
- Authorship rules
- Oral communication
- Funding of clinical studies
- Responsible use of AI in research
C5: Case-control and Diagnostic Test Studies
- Design of case-control studies
- Critical appraisal of published literature
- Logistic regression (simple and multiple)
- Measures of diagnostic test accuracy
- Assessing measurement agreement (Kappa statistic, Bland-Altman plots)
C6: Randomized Controlled Trials
- Principles of randomized controlled trials, including alternative and non-inferiority designs
- Practical organisation of a randomized clinical trial
- Statistical analysis plan: intention-to-treat vs. per-protocol, treatment effect measures, sample size estimation, data safety monitoring, and interim analyses
- Survival and time-to-event analysis, including Kaplan-Meier curves and Cox regression
C7: Systematic Reviews and Meta-Analysis
- Principles and practical conduct of systematic reviews
- Literature search
- Critical appraisal of systematic reviews and meta-analyses
- Meta-analysis
C8: Prognostic Research
- Concepts and methods of prognostic research
- Development and validation of prognostic models and their relevance to clinical decision-making
- Critical appraisal of prognostic models
Elective modules
E1: Introduction to Qualitative Health Research
- Principles and design of qualitative health research
- Data generation approaches (e.g., qualitative interviews)
- Core analytical methods: reflexive thematic, grounded theory, framework, and content analysis
- Application in mixed-methods and intervention research
- Quality, rigor, ethics, and publishing in qualitative research
E2: Patient Partnerships in Clinical Care, Research and Guidelines development
- Principles of patient involvement and engagement in clinical research and care
- Selecting and maintaining patient partnerships, with real-life examples from different research settings and special interest areas (e.g. paediatrics, rare diseases)
- Introduction to clinical guideline development
- GRADE approach for assessing evidence certainty
- Evidence-to-decision framework, including patient partner discussions
E3: Integrating Sex and Gender Perspectives in Clinical Research
- General principles and international policies on the inclusion of sex and gender in health research
- Critical appraisal sex/gender bias in research design, methods, interpretation and publications
- Methods and approaches to minimise sex/gender bias
- Understanding of the importance of sex and gender in your own research projects