Study Molecular Epidemiology and Genetics of Toxoplasma gondii using Multiplex PCR-RFLP and Whole Genome Sequence Analysis

The development of molecular biology revolutionized the way investigators conduct research. Techniques such as polymerase chain reaction, sequencing, gene knockdown and others became routine tools for researchers on molecular biology field. However, researchers from other areas may be not familiarized with such techniques. Considering the importance these techniques for science development is mandatory that the students from the graduate program in Anatomy have a minimal knowledge on molecular biology, allowing them to interpret publications with molecular data and to consider multiple approaches while developing their own research projects. Provide to graduate students: theoretical and practical concepts on molecular biology techniques, with emphasis on mammalian development applications; knowledge to interpret the results generated by molecular biology assays; a critical view of molecular biology techniques that can be used in scientific investigation, development of the necessary skills to use molecular biology and to critically analyze publications with molecular data. School of Veterinary Medicine and Animal Science (FMVZ) São Paulo main campus Essentials of molecular biology, nucleic acids extraction, polymerase chain reaction, restriction fragment length polymorphism, nucleic acid sequencing, real time PCR, high resolution melting, microarrays, genotyping, western blot, transgenesis and gene silencing. 25 VPS5745 4 Students will be assessed through participation in classes and the presentation of papers.

Writing your Manuscript

This course has the objective of teaching postgraduate students to become more effective writers, using practical examples and exercises. Topics include: principles of good writing, tricks for writing faster and with less anxiety, the format of a scientific manuscript, authorship, plagiarism. At the end, the students should delivery a short paper for peer review. This step is essential for the final evaluation. To learn about how to write an effective manuscript during the postgraduate course can help the students to report adequately your scientific results. Additionally, the program and the mentors could be benefited. Ribeir_o Preto Medical School (FMRP) Ribeirão Preto campus – Scientific project approved by Ethical Committee – Data explored/analyzed (at least partially) – Fluency in English – Personal computer (notebook) – operacional systems Linus, OS, Windows – Softwares installed: text editor (suggestion: Word_ or Pages_), reference manager (suggestion: Endnote_). – Introduction, the importance of a good writing divulgation – Good relationship with a text editor – Principles of effective writing – Crafting better sentences and paragraphs – Organization; and streamlining the writing process – The format of an original manuscript – Reviews, commentaries, and opinion pieces; and the publication process – Issues in scientific writing (plagiarism, authorship, ghostwriting, reproducible research) – How to do a peer review Om_ro Benedicto Poli N_tto 25 RGO5865 6 How much of a time commitment will this course be? – You should expect this course to require 4 to 8 hours of work per week. Any additional textbooks/software required? – There is no textbook for this course. PRESENCE: 91-100%: excellent, grade A; 81-90%: above average, grade B 71-80%: satisfactory, grade C; below 70%: unsatisfactory, grade D TASKS DELIVERED ON TIME*: All of them (5/5): excellent, grade A; 80% (4/5): above average, grade B 60% (3/5): satisfactory, grade C; below 40% (2/5): unsatisfactory, grade D * Tasks will be accepted only until to one week after. * If any task is not sent at this time (one week after), the grade will be decreased by “D” level. * Presence and tasks delivered on time will be compound as “Participation”: A+A=A; A+B=A; B+A=A;B+B=B; B+C=B; C+B=B; C+C=C; C+D=D; D+C=D; D+D=D. If D, the student will not be automatically reproved in the course. FINAL REPORT: graded from zero to ten by average grade among teacher and peer review (made by two colleagues). FINAL GRADE: It will be equal to �gFinal report�h x 100% if �gParticipation�h=A or 85% if �gParticipation”=B or 70% if �gParticipation�h=C. ATTENTION: Final grade will not be attributed if �gParticipation”=D. IMPORTANT: If any sign of plagiarism is detected, the student will have one additional week to sent a new version of the final work and will have the final grade decreased in 20%._

Immunotherapies and cellular therapies: concepts and applications

Currently, immunotherapy is an important therapeutic approach for the treatment of several diseases. In this context, this discipline is justified by addressing the current state and new perspectives of immunotherapies and advanced cellular therapies, making a connection between basic concepts and possible preclinical and clinical applications. Immunotherapy for cancer treatment is currently the most promising therapy in view of its selectivity, curative potential and low toxicity. This type of therapy has been described as the major scientific event of 2013 by the journal Science with emphasis on therapies with monoclonal antibodies (anti-CTLA-4 and anti-PD1) and genetically modified chimeric antigen receptor T cells (Chimeric Antigen Receptor T Cells, CAR T cells), which were able to induce potent antitumor response. In addition, this course enables interaction with professors and researchers from our and other research institutions, which develop works in this area of knowledge and present significant scientific and/or technological contribution in the field. The objective of this course is to introduce concepts about immunotherapies and cell therapies, as well as to discuss their application in the treatment of several types of diseases (hematological neoplasms, solid tumors, inflammatory diseases and immuno-mediated diseases.) In this context, immunotherapies already well established in the clinical context as well as innovative and advanced therapies using, for example, multipotent stem cells and genetically modified T cells. In addition, biotechnological advances in the areas of immunotherapy and cell therapy will be addressed. Ribeir_o Preto Medical School (FMRP) Ribeirão Preto campus The course will be taught through lectures, seminar presentation and discussion of articles. It will cover the following topics: 1. Immunotherapy, cell therapy, gene therapy: concepts and definitions. 2. Cellular immunotherapy (eg, NK cells, genetically modified T cells, dendritic cells, regulatory T cells, among others). 3. Immunotherapeutics (eg monoclonal antibodies, soluble receptors, receptor antagonists, purified total immunoglobulins, among others). 4. Immunotherapy: preclinical and clinical applications. 5. New biotechnologies in the area of immunotherapy (genetic modification, construction of chimeric antigen receptors, bioprocesses for cell expansion in bioreactors, humanized antibodies, among others). Maria Carolina de Oliveira Rodrigues,Kelen Cristina Ribeiro Malmegrim de Farias, Cristina Ribeiro de Barros Cardoso 25 RIM5754 4 There will also be the participation of invited researchers from this and other institutions every time the discipline is offered. 1) Didactic-scientific performance in seminars 2) Participation in discussions during lectures and seminars 3) Frequency

Statistical Basis for Research

Considering that graduate courses aim to develop qualified faculty and researchers, able to conduct research protocols independently, it is necessary to offer disciplines which prepare students with adequate statistical tools for the analysis of collected data from health research protocols. At the end of this discipline students should be able to: 1. Recognize and classify research variables as well as understand the consequences of this classification on statistical analysis; 2. Present collected data in a reduced form applying tables and graphics; 3. Distinghish the most used probability distributions and relate them to their respective statistical tests; 4. Define Type I and Type II errors, and how they are related to the sample size; 5. Indicate apropriate statistical tests to run univariate and bivariate hypothesis tests; 6. Interpret results of univariate and bivariate statistical analysis. Medical School (FM) São Paulo, Pinheiros campus 1. Descriptive Statistics: variables; reducing and presenting data (graphs and tables); frequencies; central tendency measures and dispersion. 2. Introduction to Probability: axioms; dependent e independente events; conditional probability; Probability distribution: Binomial, Poisson, Normal, F, t e _2; 3. Inferential statistics: hypothesis testing; type I and type II errors. Confidence interval; z test. Sample size calculation and study power. 4. Tests for quantitative variables: t test; paired t teste; F test; ANOVA, Pearson correlation. 5. Tests for ordinal variables: Mann-Whitney test; Wilcoxon test; Kruskal-Wallis test; Spearman correlation. 6. Tests for categorical variables: _2 test; Exact Fisher test; Relative Risk; Odds Ratio; Cochran-Mantel-Haenszel method. Luiz Felipe Pinho Moreira, Raymundo Soares de Azevedo Neto 30 MPT5802 2 This discipline is offered at the School of Medicine main building as well as in a distance learning format. In the distance learning format, students will watch classes and discuss the topics through MOODLE platform (Stoa _ ). Final exam is performed at the School of Medicine. A final exam, with multiple choice questions, will be carry out at the end of the discipline, being necessary a score higher than 50 of 100 points for the student to get approved.

Advanced Topics on Hematopoiesis and Hematopoietic Stem Cell Diseases

This course covers the current knowledge on the molecular and cellular mechanisms involved in the control of hematopoiesis and hematopoietic defects that are etiologic in human hematologic disorders Discussing the cell and molecular mechanisms of control of hematopoiesis, maintenance of pluripotency and hematopoietic stem cell differentiation. Discussing the mechanisms regulating hematopoiesis which are abnormal in hematological diseases, particularly in bone marrow failure and myeloid neoplasias. Ribeir_o Preto Medical School (FMRP) Ribeir_o Preto campus Lectures on (1) hematopoiesis and (2) bone marrow failure. Seminars on pluripotency, stemness, hematopoietic differentiation, cellular reprogramming; immunology of hematopoiesis, niche; DNA repair machinery, telomere biology, clonality in hematopoieses, malignant clonal evelution, epigenetics, and investigational tools: Southern blot, Westem blot, coimmunoprecipitation, qPCR, PCR-array, genetic sequencing, colony-forming assays; immunophenotyping Rodrigo do Tocantins Calado de Saloma Rodrigues 4 OCT5717 4 The discipline is held in a weekly basis and students’ evaluation will be based on: 1. Frequency and participation; 2. Seminars presentation; 3. Top

Development of Ideas, Brands and Patents in Medicine

The subject, besides fulfilling the primary aim of the “gstrictu senso”h post-graduation of training researchers, combines the need for stimulation, starting at a brilliant idea (the Concept of Intellectual Capital, where the knowledge or creativity can be converted into economic value) up to the development of products, and their branding and patenting. To present the postgraduate students the understanding, skills and attitudes which must be developed to enable getting a brand and patent, from the conception of an idea – To stimulate the creativity of the postgraduate student in the creation of innovative products, which could become innovations with their institutional domain guaranteed. Medical School (FM) São Paulo, Pinheiros campus Define what intellectual property is, and identify its importance for Brazilian industry Since when have people sought to protect intellectual property? What is intellectual property? What does intellectual property cover? Current regulationary framework that deals with intellectual property in Brazil Conceptualize about what copyright and related rights are and their implications What guarantees copyright in Brazil? Copyright Related rights Explain what the rights are over a computer program Computer Program Identify what industrial property is and its applications: patents of invention and utility model, trade mark, industrial design and geographical indications. Who guarantees and grants the right of industrial property in Brazil? What does the expression industrial property cover? What is the purpose of industrial property Patent of Invention and Utility Model Industrial Design Registration Trademark Registration Registration of Geographical Indications Repression of Unfair Competition Current regulatory framework to support innovation in Brazil Having ideas in Gastroenterolgy (a. innovation which could be patented; b. methods for scientifically developing an idea; c. putting the project into practice. – Idea Development Projects, trademarks and patents in Endoscopy and Interventional Radiology – Idea Development Projects, trademarks and patents in Surgery. Orlando de Castro e Silva J_nior, Eduardo Guimar_es Hourneaux de Moura, Wanderley Marques Bernardo 34 MGT5773 4 Concepts which involve the proposed subject: – Idea: The word derives from the Greek idea or eidea, etiological root is eidos _ image. Its significance, since its origin, implies a controversy between the theory of emission (Plato) and that of intromission (Aristotle). At the center of the controversy is the concept of the representation of the real (reality). For Plato, the idea we have from something proves the main principal, of the _intelligible world_, which constituted the Universal Idea, a category which is the basis of his philosophy, idealism. So, the idea of it is a projection of knowledge: upon seeing it, the eyes, emitting rays of light, project the image of the same thing, which exists within us as the universal principle (emission). This doctrine is designed by _idealism_. For Aristotle, the idea of the thing comes from sense experience, from the _world of contingent phenomena_: the things emit copies of themselves, through the light, copies assimilated by senses and interpretated by innate or acquired knowledge (intromission), a doctrine that founds the concept of _realism_. The (brilliant) idea is the basis of everything (four steps: preparation, incubation, illumination and verification). Any time lost after a brilliant idea could be responsible for inhibiting the motivation which created idea, or even raise doubts whether the brilliant idea is really good or not. – Intellectual property: refers, in the broad sense, to the creations of human spirit and to the protective rights of the interests of the creators over their creations. – Trademark: Is a visually perceptible sign capable of distinguishing the goods or services of a company, especially in relation to other competitors. – Patent: is a title of temporary ownership over an invention of utility model, granted by the State. With this right, the inventor has the right to prevent third-parties, without their consent, of producing, using, putting for sale, selling or importing the subject of their patent and/or process or product obtained directly by a process patented by him. _Assessment by: above 75% presence in lesson, presentation of seminars with pre-determined topics, performance and interest demonstrated during the discussions.

Malaria and Neglected Tropical Diseases: Advances in Knowledge and Challenges for Control

Despite unprecedented efforts to control malaria, this disease still represents a major public health problem, particularly in Africa. Challenges such as the search for more sensitive point-of-care methods, resistance to antimalarials and to insecticides, strategies to measure transmission, understanding of the immunity and decreases lethality are challenges for the control and elimination. Malaria is the most widespread parasitic disease, putting at risk about 3.3 billion people worldwide, with 198 million cases and 584,000 deaths, especially in children under five years of age and pregnant women. Leishmaniasis and arboviruses such as dengue are among the vector-borne diseases considered neglected by the World Health Organization. Neglected tropical diseases are a group of communicable diseases occrurring in tropical and subtropical conditions in 149 countries and affect more than one billion people, at the cost of billions of dollars each year. They affect mainly populations that live in poverty, in contact with vectors of infectious agents. About 450 million people in sub-Saharan Africa are at risk of contracting tropical diseases. However, according to the WHO, they also affect Latin America, the Middle East and Asia and can emerge in other regions. Leishmaniasis accounts for 1.5 to 2 million new cases per year, with an average lethality of 7%, mainly due to the visceral type. In recent years there has been a resurgence of different arboviruses, among them dengue, chikungunya and Zika virus, whose ability to adapt to different vectors had an impact on the geographical expansion of these diseases. Although most cases present benignly, these arboviruses can occur with severe manifestations. The risk of transmission of these diseases is not limited to populations living in areas at risk, but also to travelers, due to globalization and ease of displacement, thus increasing the concern of worldwide dissemination. The extent of these diseases, coupled with the complex mechanisms of the agent-host-vector relationship in the different phases of the transmission chain, suggests that it is appropriate for academic and public health institutions to devote themselves to the study of the variables involved in their evolution. Thus, the knowledge related to the agents, the hosts, the vectors and the interaction between them, is fundamental to draw efficient strategies of control. In this context, the main challenges are the critical and accurate evaluation of parasitological and molecular diagnostic methods; the immunological mechanisms involved in the etiologic agent-man-vector relationship; the genetic mechanisms of drug resistance; the importance of travel medicine, in order to guide and prevent the risk of infection. It is proposed here a course at a postgraduate level that will provide students with the conditions to develop a critical vision, that arises from the knowledge of challenges, proposals for control and research perspectives in the related field. Training teachers and researchers to develop research on malaria and the main neglected tropical diseases, with an approach in epidemiology and clinical-laboratory diagnosis, encouraging and stimulating the critical thinking related to the knowledge in these diseases. Medical School (FM) São Paulo, Pinheiros campus 1. Challenges for malaria control: biological, epidemiological and environmental components; dynamics of transmission in different endemicities; determinants of malaria; characteristics of extra-Amazonian malaria; 2. New perspectives in laboratory diagnosis of malaria: performance of molecular protocols and adequacy of their use in different situations; critical analysis of immunochromatographic assays for the detection of specific antigens and antibodies; 3. Development of immunity in malaria: main mechanisms involved in the cellular and humoral immune response; current state of vaccine development; 4. Immunopathogenic aspects of malaria and correlation with clinical manifestations: characteristics of severe malaria; 5. Chemotherapy; genetics of antimalarial resistance and major molecular markers; 6. Challenges for the control of leishmaniasis: determinants of the disease endemicity, mechanisms related to environmental factors contributing to the spread of the disease; 7. Diversity of Leishmania species occurring in Brazil: geographical location; clinical forms of disease; species and genotypes of Leishmania-related therapeutic response; 8. Innate and adaptive immunity in leishmaniasis: immunopathogenic aspects of the different clinical forms of tegumentary and visceral leishmaniasis; 9. Clinical-laboratory diagnosis of leishmaniasis; clinical aspects in immunocompetent and co-infected patients with HIV; difference in clinical manifestations and therapeutic response; evaluation of laboratory methods currently employed in the diagnosis of visceral and tegumentary leishmaniasis; perspectives of new antigens and different diagnostic platforms; molecular tools used in the species-specific diagnosis of leishmaniasis; 10. Challenges for the control of arboviruses of urban occurrence: biological, epidemiological and environmental components; dynamics of transmission in different scenarios; vectors and host susceptibility; 11. Challenges for serological and molecular diagnosis of arbovirus; 12. Immunopathogenic aspects of arboviruses and correlation with clinical manifestations; 13. Traveler’s medicine: critical analysis of prevention measures and chemoprophylaxis Marcos Boulos, Jos_ Angelo Lauletta Lindoso, S_lvia Maria F_tima di Santi 50 MIP5714 5 Elaboration of a project as a mechanism of evaluation of the student’s perception of the importance of each theme presented. Presentation of seminars with discussion of results of published studies

Research Applied to HIV / AIDS Infection: Approaches, Methods and Techniques

HIV / AIDS infection is a serious health problem today and its repercussions are felt in many aspects of human life. Well-conducted scientific research can contribute to the generation of knowledge in coping with this epidemic, focusing on components of the complex network of related biopsychosocial factors. Considering that the technical preparation for the planning and execution of scientific research is essential for the training of the researcher, this discipline intends to offer subsidies to the process of elaboration, reading and critical analysis of research projects applied to the deepening the knowledge regarding HIV infection AIDS, with emphasis on the interdisciplinary approach. A) To discuss the process of scientific investigation that has as object the study of HIV / AIDS infection, including its planning, main approaches, methods and techniques. B) To provide subsidies for the formulation of research projects focused on this theme. C) To enable students to analyze literature about the subject, through a fair interpretation of the most frequently used research methods. D) To stimulate the interdisciplinary approach in scientific research related to HIV / AIDS infection Medical School (FM) São Paulo, Pinheiros campus • Fundamentals of scientific research: observation and experimentation; metering; probability, Induction; • Research planning: the research process; • Selection and formulation of the scientific inquiry of the research; • Bibliographic research survey; • Research planning: study designs applied to HIV / AIDS infection (quantitative observational and intervention studies, qualitative studies); • Selection of subjects for the research: sample calculation and sampling criteria, recruitment of subjects; • Data collection and use of data as a source of information (quality and quantity); • Measurement of results (accuracy); • Planning of the analysis and interpretation of results; • The research report; • Ethical aspects of research involving human beings; • Research funding. Aluisio Augusto Cotrim Segurado, Ana Marli Christovam Sartori, Eliana Battaggia Gutierrez 70 MIP5734 5 The selection of students for the subject will require the submission of scientific research proposal related to HIV / AIDS infection. The evaluation will be based on the attribution of a concept regarding the interest and participation of the students in the proposed activities – classes, seminars, guided exercises, as well as the presentation of an individual research project at the end of the course.

Clinical Epidemiology

The epidemiological methodology, along with its traditional use in the area of Collective Health, has been used as a privileged instrument in conducting clinical research. Epidemiology techniques have been useful in addressing the issues that characterize clinical work, both from the perspective of health services and from scientific research. The aim of this course is to systematize the existing knowledge about the application of this methodology in the development of technical-scientific production in Clinic, as well as in the implementation of its practice. To understand the application of epidemiological methodology in clinical research; To know the basic technical elements for elaboration and conduction of research projects; Encourage the ability to critically evaluate scientific articles published in the medical literature; To provide instruments for the improvement of clinical practice, based on the critical evaluation of the literature. Medical School (FM) São Paulo, Pinheiros campus The course will consist of theoretical classes, seminars and practical classes, covering the following topics: Definition of Epidemiology and its main concepts; Studies on diagnostic tests; Prognostic studies; Experimental Studies; Tracking; Systematic reviews; Critical reading of medical publications; Discussion of research projects in Clinical Epidemiology. Moises Goldbaum, Moacyr Roberto Cuce Nobre, Paulo Rossi Menezes 35 MPR5730 6 The evaluation will consist of attendance, participation and presentation of seminars and individual test.

Prevention of Diseases, Promotion of Health and Reduction of Vulnerability: Historical Evolution of Concepts and Opportunities of Interprofessional Practices

International and national initiatives have as one of the objectives to reorient professional training, ensuring an integral approach to the health-disease process. The conceptual understanding, as well as the understanding of the historical and social roots that justify the emphasis on basic health care and strategies for health promotion and reduction of vulnerabilities, is pressing to support such a reorientation. – Present theoretical assumptions and practical implications in the historical emergency process and development of the concepts of Natural History of Disease / Levels of Prevention, Health Promotion and Vulnerability. – Reflect on the processes of historical transformation of conceptions and practices on the health-disease-care processes. – Reflect on the involvement and challenges for the interprofessional team in the provision of actions to prevent injuries, health promotion and reduction of vulnerability. Medical School (FM) São Paulo, Pinheiros campus The focus of the program is on the historical emergence of the concepts of multi-causality, Natural History of Diseases and Levels of Prevention. International and national benchmarks on health promotion. Discussion of the concept of vulnerability and network construction (intersectoriality). The role of health disciplines and professions in the three approaches (prevention, promotion and vulnerability), as well as the new pedagogical strategies applied to the field of health communication are examined. CLASSROOM SCHEDULE 1 1st part: Presentation of the students + presentation of the proposal of the discipline and the evaluation form – (registration for use of Dropbox) Profa Ana Claudia Germani Part 2: Visit to the museum of FMUSP + Lecture on Medicine and Historicity Prof. Andr_ Mota 2 1st part: History of medical practice and diseases Profo Andr_ Motta 2nd part: HND and levels of prevention. Prof. Jose Ricardo Ayres 3 General concepts of Health promotion in Brazil and in the world: opportunities for interprofessionality and intersectoriality. Profa Ana Claudia Germani 4 Vulnerability Profo Jose Ricardo Ayres 5 Communication on disease prevention and health promotion practices Profa Ricardo Teixeira 6 Course and student evaluation Andre Mota, Jose Ricardo de Carvalho Mesquita Ayres, Ana Claudia Camargo Gon_alves Germani 25 MPR5757 4 Frequency: Weight 1 Self assessment (performed individually on the last day of class, through interview of the student and responsible teachers): weight 1 Class Activities: Weight 2 Final evaluation – exercise: weight 6

Body in Perspective in Collective Health

The subject of the body is classic in the Human and Social Sciences with contributions from different disciplinary fields such as Anthropology, History and Sociology. In the country, the development of this area of __research and the consequent theoretical-conceptual consolidation gained momentum starting in the 1950s. Collective Health, as a field of knowledge and practices, has fostered the constitution of a growing and rich dialogue between the Health and humanities. In this sense, we present the proposal of a discipline on the body proposing the articulation of the disciplinary contributions of Anthropology, History and Sociology in the conformation of the thematic, at the same time, biological and cultural, related to the own social construction of the person and its relevance in the Processes conformed in the care, in the therapeutic practices, in the aesthetic interventions, in the suffering and the pain in face of the processes of illness and in the perception of the body in face of normative processes. The discipline has a theoretical and applied character, allowing to study the articulations of the subject under the referential of the disciplinary fields marked with its applications in the recent researches in the field of health, in addition to enabling, even if still basic, in the critical and reasoned reading of the Productions in the field of health that make use of the mentioned references. 1. Discuss the relationships between body, health, illness and care understood in their symbolic, social and historically constructed dimension; 2. Placing the studies on the body in the field of Human and Social Sciences, starting with the classic nature and culture dichotomy and inserting the contemporary critical debate of this tradition; 3. Contextualize the question of body and identity in the consumer society; 4. Present the concept of stigma and discuss its main repercussions in terms of prejudice, discrimination and exclusion for individuals and populations; 5. Present and discuss definitions about body, forms of care and curative or aesthetic interventions and their main repercussions in health studies; 6. Place the studies on sexuality and reproduction from the perspective of normative / therapeutic perspective on the subject, highlighting the contribution of gender studies in the understanding of the phenomenon that appears as a reference of articulation of the individual and the social, the subjective And the goal; 7. Analyze the relation body and work in contemporary society and its main repercussions in terms of needs of the productive system, training to the time of production, construction of subjectivities, illness and care. Medical School (FM) São Paulo, Pinheiros campus • Body as an object to think about the individual-society relationship in history; • Health-sickness and care in the socio-anthropological perspective; • Body, birth and death; • Corporalities and life cycles; • Body, reproduction and sexuality; • Biomedicine, medicalization and biopolitics of the body; • Work, body and subjectivity; • Body, pain and suffering; • Body, stigma, prejudice and rights. Andre Mota, Rosana Machin Barbosa, Maria Thereza Couto Falc_o 30 MPR5770 8 Participation and exercises in class. Written assessment _ individual test.

Ethical and Methodological Principles in Clinical Research

Clinical research is a growing field and demands well prepared researchers from all _reas of health graduation courses. The complexity and variety of methods appied to clinical research, as well as the ethical issues brought by the proposition of protocols in this _rea require adequate training and background. Graduate students, both from master and PhD courses, need to enhance their knowledge and practice in the topics related to clinical research. To present and to discuss ethical basis and main methods of clinical research based on good practice principles. At the end of the discipline, graduate students will be able to write a research protocol, to analyze their project data and to elaborate a publication in their research field. Medical School (FM) São Paulo, Pinheiros campus 1. Ethical and bioethical principles 2. Research question 3. Clinical variables: biomarkers and surrogate endpoints 4. Statistical basis 5. Study design 6. Sampling, validity, bias, randomization and blinding 7. Advanced statistical methods 8. Sample size calculation 9. Assessment of adverse effects and medication adherence 10. Adaptative design and interim analyses 11. Propensity scores 12. Writing a protocol 13. Clinical research as a profession 14. Publishing Wu Tu Hsing Raymundo Soares de Azevedo Neto 30 MPT5795 15 Being an on-line discipline, presence is evaluated by student participation in the discussion forum at least once each week, and the quality of comments posted are graded. Week assignments and a final exam at the end of the discipline compose the final grade of the student.