Course details

FacultyHealth Sciences
Education levelPostgraduate / Master of Science
Course codeC2Semester1
Course titleClinical Research Methodology
Independent teaching activitiesHours per weekECTS
CoursetypeGeneral setting course, skills development
Prerequisite coursesNone
Teaching and assessment languageEnglish

Learning outcomes


Upon completion of the course, the student will become familiar with the basic principles of clinical research methodology, and will be able to apply the basic principles of evidence-based medicine in everyday clinical practice.


Upon completion of the course, graduate students will be familiar with:

  • The essential principles of clinical research methodology
  • The basic principles of evidence-based medicine
  • The basic terms of clinical epidemiology (incidence, prevalence)

The course participants upon completion will be able to:

  • Apply the principles of evidence-based medicine in daily clinical practice
  • Evaluate and choose the most appropriate diagnostic test, based on sensitivity and specificity of the test
  • Set priorities in selecting treatment regimens based on the expected benefit
  • Transform clinical cases in well formulated research questions
  • Seek primary and secondary evidence
  • Make critical review of data

Course contents

  1. Formulation of the research question
    Formulation of research question, formulation of search strategy, bibliographic databases
  2. Searching bibliography principles
    Principles of bibliography search – Bibliographic databases
  3. Basic statistical principles
    Morbidity, correlation measures, diagnostic accuracy measures, confidence intervals
  4. Randomized clinical trials (RCTs)
    RCTs design, recruitment, randomization, allocation concealment, blinding, losses during follow-up, analysis based on the intention to treat principle, critical appraisal of RCT
  5. Systematic reviews (SRs) – meta-analysis
    Formulating a clinical question, setting eligibility criteria, searching for studies, extraction of data from clinical trials, quality assessment of studies included, statistical analysis, investigation of heterogeneity, presentation of results, critical appraisal of SR
  6. Studies of diagnostic accuracy
    What is normal / abnormal? Assessing validity of diagnostic studies. Assessing quality of diagnostic studies. Sensitivity / specificity, likelihood ratios, Odds ratios, SpPIn and SnNOut mnemonics.
  7. Observational studies
    Observational studies. Cohort studies. Case-control studies. Cross-sectional studies. Case reports.
  8. Evidence-based medicine
    What is evidence-based medicine? Why is there is interest for evidence-based medicine? How does one practice evidence-based medicine? Can clinicians apply or in ciples of evidence-based medicine in everyday clinical practice? What is the evidence supporting use of evidence-based practice? Which are the limitations of evidence-based medicine?

Teaching and learning methods – evaluation

Teaching methodsFace to face
Distance learning
Use of information and
communication technologies (ICT)

  • Use of ICT in Teaching- Moodle Virtual learning environment (VLE)
    (asynchronous learning, wikis, Online Discussion Fora, Educational Portfolio, assignment submission, assessment process)

  • Use of ICT in Communication with students
    (email, instant messaging via Moodle)

Module structureWork Hours per SemesterActivity
Lectures 78
Exercises (Quiz) 20
Exercises (Wikis) 18
Exercises (Online discussion fora) 20
Exercises (Study relevant papers) 20
Essay background work64
Essay writing30
Overall work for the course250
Assessment Methods
  • Written assignment, in English, approximately 2,500 words long, to be submitted by each student at the end of the course

  • Assessment of knowledge at the beginning and the end of the course with short-answer questions and essays development

  • Weekly quizes, with multiple choice questions

  • Assessment based on comments submitted by each student in online discussion fora

Recommended Bibliography

  1. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. 1996;312(7023):71-2.
  2. Windish D. Searching for the right evidence: how to answer your clinicalΒ questions using the 6S hierarchy. Evid Based Med. 2013;18(3):93-7
  3. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2(8):e124.
  4. Haynes RB, McKibbon KA, Wilczynski NL, Walter SD, Werre SR; Hedges Team. Optimal search strategies for retrieving scientifically strong studies ofΒ treatment from Medline: analytical survey. BMJ. 2005;330(7501):1179
  5. Ely JW, Osheroff JA, Ebell MH, Bergus GR, Levy BT, Chambliss ML, Evans ER. Analysis of questions asked by family doctors regarding patient care. BMJ. 1999;319(7206):358-61
  6. Del Fiol G, Workman TE, Gorman PN. Clinical questions raised by clinicians at the point of care: a systematic review. JAMA Intern Med. 2014;174(5):710-8.
  7. Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet. 2002;359(9305):515-9.
  8. Knottnerus JA, van Weel C, Muris JW. Evaluation of diagnostic procedures. BMJ. 2002 Feb 23;324(7335):477-80.
  9. Sackett DL, Haynes RB. The architecture of diagnostic research. BMJ. 2002 Mar 2;324(7336):539-41
  10. Irwig L, Bossuyt P, Glasziou P, Gatsonis C, Lijmer J. Designing studies to ensure that estimates of test accuracy are transferable. BMJ. 2002 Mar 16;324(7338):669-71.
  11. Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet. 2002 Jan 26;359(9303):341-5.
  12. Schulz KF, Grimes DA. Case-control studies: research in reverse. Lancet. 2002 Feb 2;359(9304):431-4.
  13. Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet. 2002 Jan 19;359(9302):248-52.
  14. Grimes DA, Schulz KF. Descriptive studies: what they can and cannot do. Lancet. 2002 Jan 12;359(9301):145-9.
  15. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. PubMed PMID: 10819955.