Conoce las funciones de un Investigador Principal, un Monitor y un Promotor, para adaptar tu perfil profesional a la figura que más te interese” 

En un Ensayo Clínico existen diferentes figuras que forman parte relevante en el proceso, además de la de Investigador Principal. Destacan el Promotor, encargado de reunir a los especialistas que llevarán a cabo el estudio, así como el Monitor, que es el nexo de unión entre este equipo y la que habitualmente suele ser una compañía promotora. Estas profesiones están en constante alza y requieren de una especialización profunda y avanzada. 

Por ese motivo, TECH ha diseñado un Postgraduate certificate en Clinical Trials, Principal Investigator, Monitor and Sponsor, para dotar a los alumnos de las habilidades y competencias necesarias para abordar estas funciones con total eficiencia y conocimientos específicos. De esta forma, los contenidos ahondan en temas como el Diseño del Estudio, la Veterinaria Basada en la Evidencia, la Normativa Ética y Legal, el Equipo de Investigación y el Control de Calidad o los Patrocinadores de Estudios Clínicos, entre otros muchos temas. 

Todo ello, en una cómoda modalidad 100% online que da total libertad al alumno para organizar sus estudios y sus horarios, sin limitaciones de ningún tipo. Además, pudiendo contar con los contenidos teóricos y prácticos más completos y actualizados del mercado académico, accesibles desde cualquier dispositivo con conexión a internet. 

Entrena tus habilidades como Monitor o Promotor y alcanza un futuro prometedor en una de las áreas con mayor futuro profesional del ámbito veterinario” 

Este Postgraduate certificate en Clinical Trials, Principal Investigator, Monitor and Sponsor contiene el programa científico más completo y actualizado del mercado. Sus características más destacadas son:

• El desarrollo de casos prácticos presentados por expertos en Ensayo Clínico Investigador Principal, Monitor y Promotor 
• Los contenidos gráficos, esquemáticos y eminentemente prácticos con los que está concebido recogen una información científica y práctica sobre aquellas disciplinas indispensables para el ejercicio profesional 
• Los ejercicios prácticos donde realizar el proceso de autoevaluación para mejorar el aprendizaje 
• Su especial hincapié en metodologías innovadoras  

• Las lecciones teóricas, preguntas al experto, foros de discusión de temas controvertidos y trabajos de reflexión individual 
• La disponibilidad de acceso a los contenidos desde cualquier dispositivo fijo o portátil con conexión a internet 

Gracias a su modalidad 100% online, el contenido estará disponible en el Campus Virtual desde el principio del curso, para que puedas disfrutarlo siempre que quieras” 

El programa incluye en su cuadro docente a profesionales del sector que vierten en esta capacitación la experiencia de su trabajo, además de reconocidos especialistas de sociedades de referencia y universidades de prestigio.  

Su contenido multimedia, elaborado con la última tecnología educativa, permitirá al profesional un aprendizaje situado y contextual, es decir, un entorno simulado que proporcionará una capacitación inmersiva programada para entrenarse ante situaciones reales.  

El diseño de este programa se centra en el Aprendizaje Basado en Problemas, mediante el cual el profesional deberá tratar de resolver las distintas situaciones de práctica profesional que se le planteen a lo largo del curso académico. Para ello, contará con la ayuda de un novedoso sistema de vídeo interactivo realizado por reconocidos expertos. 

Dispondrás de toda la información necesaria para ahondar en Protocolos, Informes e Interacción con el Investigador"

Una titulación diseñada para que alcances la excelencia profesional en el entorno veterinario"

TECH has selected the best team of experts to shape a unique and completely innovative curriculum. The structure and content of this program have been designed under the Relearning pedagogical methodology, with which the students assimilate the concepts in an agile, natural and progressive way, without having to dedicate too much time to study.

Acquire your new knowledge in a progressive, natural and precise way, thanks to TECH Relearning"  

Module 1. Clinical Research and Clinical Trials Evidence-Based Veterinary Medicine (EBVM)

1.1. Evolution of Clinical Research: Historical Aspects

1.1.1. Pre-James Lind Era
1.1.2. James Lind and Scurvy Trial
1.1.3. Arrival of Placebo
1.1.4. First Double-Blind Controlled Trial
1.1.5. First Randomized Curative Trial: The Streptomycin Randomized Trial

1.2. Research. Scientific Method

1.2.1. Research

1.2.1.1. Necessary Conditions for Conducting Research
1.2.1.2. Research Methodology
1.2.1.3. Research Memory

1.2.2. Scientific Method

1.2.2.1. Concept
1.2.2.2. Objectives of the Scientific Method
1.2.2.3. Characteristics of the Scientific Method
1.2.2.4. Budgets of the Scientific Method
1.2.2.5. Techniques of the Scientific Method
1.2.2.6. Stages of the Scientific Method

1.2.3. Summary

1.3. Clinical Research

1.3.1. The Anatomy and Physiology of Clinical Research
1.3.2. Anatomy of Clinical Research: What Does It Involve?

1.3.2.1. The Research Question
1.3.2.2. Background and Significance
1.3.2.3. Design
1.3.2.4. Study Subjects
1.3.2.5. Variables
1.3.2.6. Statistics

1.3.3. Research Physiology: What Does It Involve?

1.3.3.1. Study Design

1.3.3.1.1. Study Protocols
1.3.3.1.2. Compensation

1.3.3.2. Implement Studies
1.3.3.3. Causal Inference
1.3.3.4. Research Errors

1.3.3.4.1. Random Error
1.3.3.4.2. Systematic Error

1.3.4. Summary

1.4. The Research Question

1.4.1. Origins of Research Questions

1.4.1.1. Research Question in Literature
1.4.1.2. New Ideas and Techniques
1.4.1.3. Choosing a Mentor

1.4.2. Good Research Question Characteristics

1.4.2.1. Feasible

1.4.2.1.1. Number of Individuals
1.4.2.1.2. Technical Expertise
1.4.2.1.3. Time and Cost

1.4.2.2. Interested Parties
1.4.2.3. Originality
1.4.2.4. Ethics
1.4.2.5. Relevance

1.4.3. Research Question Development and Study Plan

1.4.3.1. Problems and Solutions
1.4.3.2. Primary and Secondary Questions

1.4.4. Translational Research

1.4.4.1. Translation of Research from Clinical Trials to Populations

1.4.5. Summary

1.5. Sample Size Calculation

1.5.1. Hypotheses
1.5.2. Hypotheses Types

1.5.2.1. Null and Alternative Hypothesis
1.5.2.2. One-Sided and Two-Sided Alternative Hypotheses

1.5.3. Statistical Principles

1.5.3.1. Type I and II Errors
1.5.3.2. Effect Size
1.5.3.3. Alpha (α) and Beta (β)
1.5.3.4. Probability Value (p)
1.5.3.5. Types of Statistical Tests

1.5.4. Additional Concepts

1.5.4.1. Variability
1.5.4.2. Multiple and Post Hoc Hypotheses
1.5.4.3. Primary and Secondary Hypotheses

1.5.5. Summary

1.6. Bibliographic Search: Access to Scientific Information

1.6.1. What is Scientific Information: How Is It Presented?
1.6.2. What Do We Need It For and What Should We Do With It?
1.6.3. Types of Questions
1.6.4. Preparing for the Search: Before, During and After
1.6.5. Where to Look Data Bases
1.6.6. What Do We Need to Consult Databases? Interrogation Languages and Keywords
1.6.7. Thesauri in Health Sciences
1.6.8. PubMed

1.6.8.1. Introduction
1.6.8.2. Simple Search. MESH Descriptors. Advanced Search
1.6.8.3. Filters
1.6.8.4. Results

1.6.9. Where and How to Locate Evidence

1.6.9.1. Introduction
1.6.9.2. Pyramids of Evidence and Information Sources

1.6.10. Up to Date
1.6.11. PubMed Clinical Queries
1.6.12. Evidence-Based Medicine Databases
1.6.13. How to Select, Read and Use Information

1.6.13.1. Introduction
1.6.13.2. What Does Critical Reading Look Like?
1.6.13.3. Types of Scientific Articles
1.6.13.4. How to Select and Read Information
1.6.13.5. Critical Reading and Checklists
1.6.13.6. Using Information Bibliography Managers
1.6.13.7. How to Create a Bibliography

1.6.14. Summary

1.7. Evidence-Based Veterinary Medicine (EBVM)

1.7.1. What is Evidence-Based Veterinary Medicine?

1.7.1.1. Evidence-Based Veterinary Medicine through History
1.7.1.2. Why is Evidence-Based Veterinary Medicine Important?

1.7.1.2.1. Clinical Applications

1.7.1.3. Comparison of Traditional Methods and EBVM
1.7.1.4. How Do I Start
1.7.1.5. Challenges of Evidence-Based Veterinary Medicine

1.7.2. Information Sources

1.7.2.1. Introduction
1.7.2.2. Background and Prior Knowledge
1.7.2.3. Evidence Hierarchy
1.7.2.4. Traditional Information Resources

1.7.2.4.1. Magazines
1.7.2.4.2. Textbooks and Other Publications
1.7.2.4.3. Personal Experience

1.7.3. Internet
1.7.4. Veterinary Information Resources on the Internet

1.7.4.1. CABdirec
1.7.4.2. Consultant
1.7.4.3. Inno-vet
1.7.4.4. International Veterinary Information Service
1.7.4.5. Medline/PubMed

1.7.5. Research Studies

1.7.5.1. Hierarchy of Evidence and Experimental Design
1.7.5.2. Research Methods Guide
1.7.5.3. Experimental Studies

1.7.5.3.1. Randomized Controlled Tests
1.7.5.3.2. Cross-Sectional Designs

1.7.5.4. Observational Study

1.7.5.4.1. Cohort Studies
1.7.5.4.2. Cross-Sectional Survey
1.7.5.4.3. Case Control Studies

1.7.5.5. Descriptive Studies

1.7.6. Assessing the Evidence

1.7.6.1. Introductory Concepts
1.7.6.2. Probability and Likelihood
1.7.6.3. Risk and Uncertainty
1.7.6.4. The Importance of Statistics

1.7.7. Evidence in Veterinary Education

1.7.7.1. Evidence-Based Veterinary Tools
1.7.7.2. Finding What Is and Isn't in Literature
1.7.7.3. Necessary Resources for Veterinary Evidence-based Practice
1.7.7.4. Clinical Audit in Veterinary Practice

1.7.7.4.1. What Is Clinical Audit?
1.7.7.4.2. Why Do We Need an Audit?
1.7.7.4.3. How to Perform an Audit
1.7.7.4.4. Clinical Audits in the Future

1.7.8. Summary

1.8. Animal Testing

1.8.1. Introduction
1.8.2. History

1.8.2.1. Prehistory
1.8.2.2. The Ancient Age
1.8.2.3. The Middle Ages
1.8.2.4. The Renaissance
1.8.2.5. Illustration
1.8.2.6. 19th Century
1.8.2.7. 20th century
1.8.2.8. 21st Century: Currently

1.8.3. Bioethics

1.8.3.1. Introduction to Biological Ethics
1.8.3.2. Position Against Testing
1.8.3.3. Position in Favor of Testing
1.8.3.4. Future Perspectives in Bioethics: Trends

1.9. Animal Ethics

1.9.1. Animal Ethics
1.9.2. Animal Studies
1.9.3. Critical Animal Studies
1.9.4. Animal Research

1.9.4.1. Animals in Biomedical and Pharmaceutical Research

1.9.4.1.1. Basic or Preclinical Research
1.9.4.1.2. Clinical Research
1.9.4.1.3. Biotechnology Research

1.9.4.2. Animals in Other Types of Research

1.9.4.2.1. Basic Research.
1.9.4.2.2. Commercial Product Testing
1.9.4.2.3. Military Research

1.9.5. Summary

1.10. Laboratory Animals

1.10.1. Most Commonly Used Species and Their Special Characteristics

1.10.1.1. Environmental and Management Conditions
1.10.1.2. Use of Experimental Animals

1.10.2.  Ethical Rules

1.10.2.1. International Regulations

1.10.2.1.1. Three Rs Principles
1.10.2.1.2. Declaration Universal of Rights of Animals
1.10.2.1.3. International Code of Ethics
1.10.2.1.4. Good Laboratory Practices

1.10.2.2. Ethical Regulations in Europe

1.10.2.2.1. Evans Report
1.10.2.2.2. Basel Declaration
1.10.2.2.3. Ontological Codes

1.10.3. Legal Regulations

1.10.3.1. Legal Aspects Regulations in Europe

Module 2. The Principal Investigator, Sponsor and Monitor of Veterinary Clinical Trials (VCT)

2.1. Professional Approach to Clinical Trials

2.1.1. Business, Science and Clinical Trials

2.1.1.1. Clinical Trials in the Public and Private Sector
2.1.1.2. Public-Private Preliminary Interaction

2.2. Veterinary Profession in the Context of Clinical Trials

2.2.1. Adequacy of the Veterinary Profession in Clinical Trials
2.2.2. Reasons for Conducting Clinical Trials
2.2.3. Registration and Animal Protection in Veterinary Clinical Trials
2.2.4. Follow-Up Veterinary Care

2.3. Principal Investigator's Guide

2.3.1. Researchers and Companies Technical Assistance Companies

2.3.1.1. Search Resources for Public and Private Companies
2.3.1.2. Budget Preparation Models

2.3.2. Responsibilities and Regulatory Committees

2.3.2.1. Responsibilities of Technical Assistance Centers
2.3.2.2. PI Responsibilities
2.3.2.3. Other Participants with Responsibilities
2.3.2.4. Institutional Animal Protection and Welfare Committee

2.3.3. Budget Development and Negotiation

2.3.3.1. Sponsors and their Types
2.3.3.2. Role of the Principal Investigator
2.3.3.3. Study Activation and Preliminary Reports

2.4. The Research Equipment in Veterinary Clinical Trials I

2.4.1. Research Equipment and Data Management

2.4.1.1. Principal Investigator
2.4.1.2. Other Research Participants
2.4.1.3. Clinical Trial Subjects
2.4.1.4. Databases. Management and Administration

2.5. The Research Team and Data Quality Control II

2.5.1. Data Sources
2.5.2. Choice of Database from Collection and Archiving System
2.5.3. Data Quality Control
2.5.4. Data Security Monitoring and Audits

2.6. Good Clinical Practices, Protocol Agreement and Participant Evaluation

2.6.1. Guarantees of Research Integrity and Protection of Participant's Security
2.6.2. Timing of Data Management Plans
2.6.3. Management of Research Personnel and Resources in Context
2.6.4. Automated Systems

2.7. The Principal Investigator (PI) in the Veterinary Clinical Trial

2.7.1. Administration and Financial Management of the Sponsored Program
2.7.2. Conflicts of Interest
2.7.3. Research Participant Protection
2.7.4. Environmental Health and Safety
2.7.5. Patents and Inventions
2.7.6. Export Controls

2.8. Veterinary Population Involved in Biomedical Research

2.8.1. Veterinary Population Involved in Biomedical Research
2.8.2. Relevant Activity Areas
2.8.3. Professional Merits

2.9. Sponsors of Veterinary Clinical Trials

2.9.1. Private Sector
2.9.2. Foundations
2.9.3. Other Promotion Sources

2.10. The Monitor: Training and Primary Function

2.10.1. Monitor Training and Designation

2.10.1.1. Preparation, Attitude and Qualification
2.10.1.2. Sponsors

2.10.2. Reporting Protocols and Forms

2.10.2.1. Protocol Reviews
2.10.2.2. Case Report Forms
2.10.2.3. Final Study Reports (According to VICH GL9 Competencies)

2.10.3. Interaction with Researchers, Laboratories and Laboratory Personnel

2.10.3.1. IP Selection
2.10.3.2. Laboratory Selection
2.10.3.3. Location Selection

Bet on your future and get to know in depth the figures of Principal Investigator, Monitor and Sponsor"