Contents

a) Methodological aspects: the controlled clinical trial and elements in the design of a trial. Evaluation of results and economic evaluation. Clinical trials and clinical practice: meta-analysis, Cochrane collaboration. Medicine based on tests and applicability to clinical practice. Planning and development of a clinical trial. Clinical trial protocol. Researcher's manual. Information collection methods. Measurement quality Data collection notebook (CRD). Standard work procedures (PNTs). Clinical trial monitoring. Documentation of the study. Audits and inspections. Data management. Medical writting

b) Adverse effects of medications and pharmacovigilance: need for pharmacovigilance and methods of application. Adverse reaction notification systems: spontaneous notification data, national and international programs. Analytical observational studies in pharmacoepidemiology (cohorts, cases and controls, meta-analysis). Other strategies for assessing adverse effects. Evaluation of the benefit / risk ratio. Pharmacovigilance and agents involved (regulators). Definition and classification of drug use studies. Consumer studies Quantitative and qualitative evaluation of medications. Study of the process variables: indication, therapeutic scheme and factors that condition the use of medications. Intervention studies. Pharmaceutical policy (regulators, industry and international organizations).

c) Basic type of economic evaluation study: cost minimization, cost-benefit, cost-effectiveness and cost-utility. Basic methodological elements in the economic evaluation studies. Interpretation of studies of economic evaluation of medicines.

d) Limitations of the investigation in view of its clinical impact. Evidence-based medicine and critical evaluation of medical publications. Instruments that facilitate the clinical application of research results (meta-analysis, clinical practice guides, systematic reviews). The clinical practice guides: methodology and quality assessment. Critical evaluation of observational safety and efficacy research.

e) Protection of patient rights. International ethical codes. CEICs Legislation: regional, national and supranational. Regulatory Agencies Good clinical practice The national normative evolution: the new biomedical research law.

f) Reference population and sample. Hypothesis and error. Multivariate analysis. Regression Analysis Survival Analysis Linear and generalized models. Analysis of repeated measurements.