The best program on the current academic market to bring you up to date on the latest developments in Veterinary Clinical Trials, all 100% online and in only 12 months of theoretical-practical academic experience" 

The veterinarian's role as part of a multidisciplinary team to develop new treatments applicable to humans and animals is fundamental and has taken on special relevance in recent years. Thanks to the development of clinical trials, it is now possible to have increasingly safe, effective and specialized medication for each pathology. This way, an experimental evaluation is carried out on the target species or a particular category, in order to guarantee its safety once it becomes available on the market. 

The importance of developing this practice in an appropriate environment and with conditions that guarantee compliance with animal welfare regulations, as well as on the basis of current legislation, relies on veterinary professional's involvement. For this reason, TECH has developed a complete program with which students will be able, to get up to date on the latest developments in this field, in just 12 months. 

It is a program designed by experts in the field with years of experience in research project management. Thanks to their participation, it has been possible to create a new and thorough syllabus with which specialists will be able to update their knowledge in: epidemiology applied to Veterinary Clinical Trials and its approach, the design and methodology of the processes in laboratories and farms, and the current regulations. 

Students will have 1,500 hours of the best theoretical, practical and additional content, the latter presented in different formats: detailed videos, research articles, complementary reading material and much more! Everything you need to delve in a personalized way in the different sections of the program, which will be available 100% online. You will be able to improve your veterinary skills through an academic experience adapted to your needs and those of today's industry.

A program designed to help professionals achieve excellence in the veterinary research environment through 1,500 hours of the best academic material"

This Professional master’s degree in Veterinary Clinical Trials contains the most complete and up-to-date scientific program on the market. The most important features of the program include:

• The development of case studies presented by experts in Veterinary Medicine 
• The graphic, schematic, and practical contents with which they are created, provide scientific and practical information on the disciplines that are essential for professional practice
• Practical exercises where self-assessment can be used to improve learning
• Its special emphasis on innovative methodologies 
• Theoretical lessons, questions to the expert, debate forums on controversial topics, and individual reflection assignments 
• Content that is accessible from any fixed or portable device with an Internet connection 

You will work with the most comprehensive and cutting-edge information related to clinical research applied to veterinary trials in farms and laboratories”

The program’s teaching staff includes professionals from the sector who contribute their work experience to this training program, as well as renowned specialists from leading societies and prestigious universities. 

The multimedia content, developed with the latest educational technology, will provide the professional with situated and contextual learning, i.e., a simulated environment that will provide immersive education programmed to learn in real situations. 

This program is designed around Problem-Based Learning, whereby the professional must try to solve the different professional practice situations that arise during the academic year. For this purpose, the student will be assisted by an innovative interactive video system created by renowned and experienced experts. 

All content will be available on the Virtual Campus from the beginning of the course and 100% online In addition, it can be downloaded to any device with internet connection"

A program where you will be able to perfect your skills in the analysis of veterinary genetic epidemiology and in the preventive and curative treatment of the most common diseases"

TECH uses the best academic tools and the effective and innovative Relearning methodology in all of its programs In addition, it guarantees a series of minimum hours of additional material in different formats, so that students can not only contextualize the information developed in the syllabus, but also deepen in those aspects they consider more interesting or relevant for their work performance. All this is what makes programs like this one the best in the market, thanks to these, veterinarians will be able to develop extensively and conscientiously, contributing to improve their professional future through a 100% online program. 

Thanks to the Relearning methodology, you will not have to invest extra hours studying the program, as you will see a natural and progressive updating of your knowledge" 

Module 1. Clinical Research and 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: Streptomycin Randomized Trial

1.2. Research. The 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. The 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. 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. 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. 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
 1.7.5.4. Experimental Studies 

1.7.5.4.1. Randomized Controlled Tests
1.7.5.4.2. Cross-Sectional Designs

 1.7.5.5. Observational Study 

1.7.5.5.1. Cohort Studies 
1.7.5.5.2. Cross-Sectional Survey 
1.7.5.5.3. Case Control Studies

 1.7.5.6. 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: The Present 

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. Experimental Animals Use 

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 

1.10.3. Legal Regulations 

 1.10.3.1. Legal Aspects Regulations in Europe

Module 2. Applied Epidemiology in Veterinary Clinical Trials 

2.1. Veterinary Epidemiology 

2.1.1. Historical Background. 
2.1.2. Epidemiology and Its Uses 
2.1.3. Causality Criteria

 2.1.3.1. Koch's Postulates 
 2.1.3.2. Bradford Hill Criteria 
 2.1.3.3. Evans' Postulates

2.1.4. Association Types 
2.1.5. Epidemiological Research 
2.1.6. Epidemiological Methods

 2.1.6.1. Qualitative Epidemiology 
 2.1.6.2. Quantitative Epidemiology

2.1.7. Disease Determinants

 2.1.7.1. Factors: Agent, Host, and Environment 

2.1.8. Pattern of Disease Progression 

 2.1.8.1. Transmission, Repertoires, Hosts and Vectors 
 2.1.8.2. Biological Cycles

2.1.9. Emerging Diseases and Zoonoses 

2.2. Epidemiological Data Analysis 

2.2.1. Data Collection

 2.2.1.1. Epidemiological Surveys

2.2.2. Nature of Data 
2.2.3. Databases: Examples of Veterinary Databases and Information Systems 

 2.2.3.1. Stata Databases 
 2.2.3.2. SPSS Databases

2.2.4. Types of Variables 
2.2.5. Interpretation of Results 

 2.2.5.1. Pie Charts 
 2.2.5.2. Bar Chart 
 2.2.5.3. Histograms 
 2.2.5.6. Stem and Leaves 
 2.2.5.7. Cumulative Frequency Polygon 
 2.2.5.8. Box Chart 
 2.2.5.9. Scatter Graph 

2.2.6. Cartography

 2.2.6.1. Geographic Information Systems

2.3. Population Structure 

2.3.1. Animal Population Structure 
2.3.2. Presentation of a Collective Disease

 2.3.2.1. Endemic 
 2.3.2.2. Epidemic Outbreak 
 2.3.2.3. Epidemic or Epizootic 
 2.3.2.4. Pandemic 
 2.3.2.5. Sporadic 

2.3.3. Measurement of Disease in the Population

 2.3.3.1. Prevalence 
 2.3.3.2. Incidence and Cumulative Incidence 
 2.3.3.3. Incidence Rate or Density 

2.3.4. Relationships between the Different Parameters 

 2.3.4.1. Calculation of the Relationship between Prevalence and Incidence 

2.3.5. Rate Adjustment 
2.3.6. Measuring Disease Presentation 

 2.3.6.1. Mortality and Mortality Ratio 
 2.3.6.2. Morbidity 
 2.3.6.3. Lethality 
 2.3.6.4. Survival 

2.3.7. Epidemic Curves 
2.3.8. Temporal Disease Distribution 

 2.3.8.1. Single-Source Epidemics 
 2.3.8.2. Epidemics by Propagation 
 2.3.8.3. Kendall's Theorem 

2.3.9. Evolution of Endemic Situations 

 2.3.9.1. Time Trends 
 2.3.9.2. Spatial Disease Distribution 

2.4. Epidemiological Research 

2.4.1. Study Planning 
2.4.2. Types of Epidemiological Studies 

 2.4.2.1. By Purpose 
 2.4.2.2. By Sense of Analysis 
 2.4.2.3. By Time Relationships 
 2.4.2.4. By Units of Analysis 

2.5. Diagnostic Epidemiology 

2.5.1. Use of Diagnostic Tests 
2.5.2. Diagnostic Concepts 
2.5.3. Reliability Assessment of Diagnostic Tests 

 2.5.3.1. Sensitivity. 
 2.5.3.2. Specificity 

2.5.4. Relationship between Prevalence, Sensitivity and Specificity 
2.5.5. Diagnostic Probability Ratio 
2.5.6. Jouden Test 
2.5.7. Threshold Value 
2.5.8. Concordance Out Diagnostic Tests 

 2.5.8.1. Kappa Calculation

2.6. Sample Size in Epidemiological Studies

2.6.1. What Are Samples?
2.6.2. Terms Related to Sampling

 2.6.2.1. Target Population 
 2.6.2.2. Population Study 
 2.6.2.3. Study Subjects 
 2.6.2.4. External and Internal Validity 

2.6.3. Selection Criteria 
2.6.4. Types of Sampling

 2.6.4.1. Probabilistic
 2.6.4.2. Non-Probabilistic

2.6.5. Sample Size Calculation 
2.6.6. Sample Size for Estimating the Mean of a Population 
2.6.7. Sample Size for Estimating Proportions 

 2.6.7.1. Sample Size Adjustments 
 2.6.7.2. Calculation of the Accepted Error for a Preset Sample

2.6.8. Sample Size for Estimating Difference Between Proportions 
2.6.9. Sample Size for Estimating Mean Difference 
2.6.10. Errors 

 2.6.10.1. Random Error
 2.6.10.2. Systematic Error or Bias

2.7. Observational Analytical Studies in Epidemiological Studies 

2.7.1. Effect Measures

 2.7.1.1. Case-Control Studies: Odas Ratio 
 2.7.1.2. Cohort Studies: Relative Risk 

2.7.2. Impact Measures

 2.7.2.1. Attributable Risk in Exposures 
 2.7.2.2. Fraction Attributable in Exposures 
 2.7.2.3. Attributable Population Risk 
 2.7.2.4. Population Attributable Fraction 

2.7.3. Confusion and Interaction

2.8. Experimental Studies in the Epidemiological Study

2.8.1. Types of Experimental Studies 
2.8.2. Experimental Elements 
2.8.3. Experimental Study Design 
2.8.4. Statistical Analysis 

 2.8.4.1. Exposure Effect 

2.9. Epidemiological Statistics 

2.9.1. Types of Statistics 

 2.9.1.1. Analytics
 2.9.1.2. Descriptive or Inferential

2.9.2. Relationship between Epidemiology and Biostatistics

2.10. Review in Clinical Epidemiological Research 

2.10.1. Systematic Review and Meta-Analysis 
2.10.2. Protocol 
2.10.3. Hypothesis Origin 
2.10.4. Selection of the Study Population

 2.10.4.1. Information Search 
 2.10.4.2. Inclusion Criteria

2.10.5. Data Collection

 2.10.5.1. Importance of Source and Measurement of Data

2.10.6. Combination Methods

 2.10.6.1. Mantel-Haensel Method

2.10.7. Heterogeneity Studies 
2.10.8. Publication Bias 
2.10.9. Health Significance of Meta-Analysis

Module 3. Approach to Veterinary Clinical Trials in Different Veterinary Settings Laboratories and Farms 

3.1. Biology and Animal Management

3.1.1. Interaction Between Animals and Their Environment 
3.1.2. Species Criteria 

 3.1.2.1. Mammals 
 3.1.2.2. Birds 
 3.1.2.3. Reptiles 
 3.1.2.4. Amphibians 
 3.1.2.5. Fish 

3.1.3. Procedures

 3.1.3.1. Substance Administration 
 3.1.3.2. Sample Collection 
 3.1.3.3. Surgical Procedures 

3.1.4. Animal Pain and Suffering 

 3.1.4.1. Pain Recognition 
 3.1.4.2. Euthanasia

3.2. Veterinarians' Role in Different Veterinary Fields 

3.2.1. Advantages and Disadvantages in the Different Veterinary Fields

 3.2.1.1. Communication. 

3.2.2. Adapting Protocols to the Study Environment 

 3.2.2.1. Veterinarian's Responsibilities

3.2.3. Informed consent

3.3. Special Considerations in the Practice of Clinical Trials in Laboratories and on Farms

3.3.1. Structure and Sites for Clinical Trials 

 3.3.1.1. Study Location Importance 
 3.3.1.2. Role of Laboratories 
 3.3.1.3. The Role of Farms 

3.3.2. Shipping and Handling of Samples and Medical Products 
3.3.3. Evolution of Anti-Parasitic Products 
3.3.4. Application and Therapeutics of Vaccines 
3.3.5. Responsible Antibiotic Use

 3.3.5.1. Resistance Surveillance and Monitoring

3.4. Clinical Trials in the Scope of Aquaculture 

3.4.1. Study Planning 

 3.4.1.1. Environmental Requirements 
 3.4.1.2. Access to Study Sites 
 3.4.1.3. Working Conditions: Personnel and Equipment

3.4.2. Protocol Development 
3.4.3. Types of Research Substances 

 3.4.3.1. Nutritional Treatments 
 3.4.3.2. Immersion Baths 
 3.4.3.3. Vaccines 

3.4.4. Design and Procedures 
3.4.5. Sampling 
3.4.6. Data Processing 

3.5. Clinical Trials in the Scope of Poultry 

3.5.1. Special Conditions in Poultry Farming 

 3.5.1.1. Study Structure 

3.5.2. Study Planning 
3.5.3. Protocol Development 
3.5.4. Data Processing 

3.6. Clinical Trials in Companion Animals 

3.6.1. Pet Therapy Industry 
3.6.2. Pet Characteristics 
3.6.3. Protocol Development 
3.6.4. Design and Procedures 
3.6.5. Working Conditions: Personnel and Equipment

 3.6.5.1. Protection and Precaution 

3.6.6. Study Purpose

3.7. Clinical Trials in Pig Farming 

3.7.1. The Pig Industry in Recent Years 

 3.7.1.1. Meat Quality 
 3.7.1.2. Industry Structure 
 3.7.1.3. Medical Products and the Industry

3.7.2. Good Practices and Organization of Trials 

 3.7.2.1. Participant Considerations 
 3.7.2.2. Research Site Choice 

3.7.3. Performance of Procedures

 3.7.3.1. Practical Applications 

3.8. Clinical Trials in Cattle 

3.8.1. Test Conditions and Approvals 
3.8.2. Study Sites 

 3.8.2.1. Today's Cattle Industry 
 3.8.2.2. Choice of Site

3.8.3. Livestock Transportation 
3.8.4. Test Substance Considerations 
3.8.5. Trial Inclusion and Exclusion Criteria 

 3.8.5.1. Immune Status and Weaning 
 3.8.5.2. Signs of Disease 

3.8.6. Practical Considerations

 3.8.6.1. Design and Procedures 
 3.8.6.2. Monitoring of Animals and Personnel 

3.9. Clinical Trials in Sheep and Goats 

3.9.1. Small Ruminant Industry 
3.9.2. Good Practices and Organization of Trials

 3.9.2.1. Trail Conditions 
 3.9.2.2. Protocol Development

3.9.3. Studies Site Choice 
3.9.4. Working Conditions: Personnel and Equipment 
3.9.5. Trail Monitoring 

3.10. Clinical Trials in Equids 

3.10.1. Researchers’ Role in this Area of Study 
3.10.2. Protocol Development

 3.10.2.1. Important Aspects of Treatments 
 3.10.2.2. Importance of Standardized Procedures

3.10.3. Recruitment of Individuals

 3.10.3.1. The Importance of Equine Aptitude 
 3.10.3.2. How to Choose the Sample: Age, Breed, Feed and Fitness

3.10.4. Research Site Planning 
3.10.5. Unforeseen Events and Problems During the Trial

Module 4. Veterinary Clinical Trial I. Design and Methodology 

4.1. Veterinary Clinical Trials

4.1.1. Veterinary Clinical Trial Research 
4.1.2. Conditions for Conducting a Veterinary Clinical Trial Investigation 
4.1.3. Types of Veterinary Clinical Trials

 4.1.3.1. Types of Trials According to the Study Design 
 4.1.3.2. Parallelisms 
 4.1.3.3. Crusader 
 4.1.3.4. In Pairs 
 4.1.3.5. Sequentials

4.2. Identifying Sources of Information for a Veterinary Clinical Trial

4.2.1. How To Find Information We Are Interested In

 4.2.1.1. Choice of Source 
 4.2.1.2. Resources and Access Modes 
 4.2.1.3. How to Search for the Best Evidence on a Topic

4.3. Elaboration of a Protocol for the Conduct of a Clinical Trial with Veterinary Medication 

4.3.1. General Information 
4.3.2. Justification and Objectives 
4.3.3. Test Outline

4.4. Design of the Veterinary Clinical Trials 

4.4.1. Selection of Individuals 
4.4.2. Inclusion/Exclusion Criteria 
4.4.3. Treatment 
4.4.4. Destination of Study Animals, Products Derived from Study Animals and Products under Clinical Investigation and Control Products
4.4.5. Adverse Events (AEs)

4.5. Methodology in Veterinary Clinical Trial Research 

4.5.1. Hypotheses 
4.5.2. Randomization 
4.5.3. City 
4.5.4. Sampling 
4.5.5. Uncontrolled Trials 
4.5.6. Controlled Trials

 4.5.6.1. Open 
 4.5.6.2. Blind 
 4.5.6.3. Double-Blind 
 4.5.6.4. Triple-Blind 
 4.5.6.5. Pilot 

4.6. Methodological Procedures in a Veterinary Clinical Trial (VCT)

4.6.1. Discrimination Between CD in Humans and Animals 
4.6.2. Differences 
4.6.3. Implementation 
4.6.4. External and Internal Validity 
4.6.5. Variables: 
4.6.6. Consent 
4.6.7. Reproducibility 
4.6.8. Risk 

4.7. Evaluation of the Efficiency of the Veterinary Clinical Trial.

4.7.1. Statistics 
4.7.2. Records Management 
4.7.3. Annexes Attached to Protocol 
4.7.4. Changes in Protocol 
4.7.5. References 

4.8. Research Quality in a Veterinary Clinical Trial

4.8.1. Scientific Aspects 
4.8.2. Risk-Benefit Assessment

4.9. Ethical Principles in a Veterinary Clinical Trial

4.9.1. Historical Background. 
4.9.2. Ethical Codes 
4.9.3. Application of Ethical Principles 

Module 5. Veterinary Clinical Trials II. Trial Treatment 

5.1. Description of Trail Treatment

5.1.1. What Does the Dose Description, Interval, Route and Form of Administration and Duration of the Treatment to be Trialed Depend on? 
5.1.2. Criteria for the Creation of Patterns Throughout the Trial

5.2. Application of Special Rules to the Trail Treatment

5.2.1. Situations for Application of Special Rules to Trail Treatment 
5.2.2. Measures to Assess Therapeutic Compliance in Special Situations 

 5.2.2.1. Examples of Special Situations

5.3. Response to Treatments 

5.3.1. Data Collection

5.4. Methods and Evaluation of Treatment Response

5.4.1. Description of the Methods Used for Response Assessment and Quality Control

 5.4.4.1. Complementary Tests: Laboratory Tests, Diagnostic Imaging, Electrocardiogram, etc. 

5.4.2. Evaluation of Data Obtained as a Function of Response 

5.5. Monitoring. Trial Treatment Plan

5.5.1. Monitoring Plan 
5.5.2. Research Timeline 
5.5.3. Types of Schedules

5.6. Main Problems in the Methodological Approaches to Treatment in the Trial

5.6.1. Incorrect Documentation 
5.6.2. Samples

 5.6.2.1. Missing Samples 
 5.6.2.2. Delayed Samples 
 5.6.2.3. Forgotten Parameters 
 5.6.2.4. Incorrect Sampling Times 
 5.6.2.5. Laboratory Kit Problems 

5.7. Specialized Methodology in Treatment I

5.7.1. Clinical Trials in Veterinary Oncology

 5.7.1.1. Trail Phases 
 5.7.1.2. Therapeutic Targets 
 5.7.1.3. Biological Samples 
 5.7.1.4. Bioequivalence

5.8. Specialized Methodology in Treatment II

5.8.1. Clinical Trials in Veterinary Infectious Pathology I

 5.8.1.1. Analysis Objectives 
 5.8.1.2. Epidemiological Clinical Trials Methodology

5.9. Specialized Methodology in Treatment III 

5.9.1. Clinical Trials in Veterinary Infectious Pathology. Prevention and Control of Veterinary Infectious Pathology II 

 5.9.1.1. Prevention and Control of the Disease

5.9.1.1.1. Institutional Strategies

 5.9.1.2. Risk Evaluation

5.10. Specialized Methodology in Treatment IV 

5.10.1. Clinical Trials in Veterinary Neurology

 5.10.1.1. Neurology Research

5.10.1.1.1. Research Areas

 5.10.1.2. Field Work
 5.10.1.3. Interpreting Results

Module 6. Genetic Diseases in Veterinary Clinical Trials (VCT). Veterinary Genetic Epidemiology 

6.1. Cities

6.1.1. Attributes to Highlight in a Population

 6.1.1.1. Common and Ethnicity Attributes
 6.1.1.2. Methods and Estimates of Gene Phylogeny in Populations 
 6.1.1.3. Populations, Social Level and Health Plan: Epidemiological Influence 

6.2. Distributions of Disease Traits in Animal Populations. Genetic Databases 

6.2.1. Genetic Traits and Diseases

 6.2.1.1. Qualitative Determinants of Disease 
 6.2.1.2. Quantitative Traits and Disease Susceptibility 
 6.2.1.3. Genetic Disease Databases and their Application to Epidemiology 
 6.2.1.4. NCBI Searches
 6.2.1.5. Species-Specific Databases on Genetic Diseases 

6.3. nteraction in the Genetic Epidemiological Triad 

6.3.1. Elements of the Epidemiological Triad 
6.3.2. Host, Genetic Make-Up and Environment 

 6.3.2.1. Genetic Make-Up and its Relevance 
 6.3.2.2. Genotype-Environment Interaction 

6.4. Genetic Epidemiology in the Light of Koch's Postulates. Part I 

6.4.1. Epidemiology of Cytogenetic Animals
6.4.2. Diseases Due to Genetic Alterations of Major Effect 

 6.4.2.1. Cause of Disease: Single Gene Disorders “Monogenic" 
 6.4.2.2. Genetic Heterogeneity in Monogenic Diseases

6.5. Genetic Epidemiology in the Light of Koch's Postulates. Part II 

6.5.1. Multifactorial Cause of Disease: Genetic Component

 6.5.1.1. High Heritability 
 6.5.1.2. Low Heritability

6.5.2. Multifactorial Cause of Disease: Environmental Component

 6.5.2.1. Infectious Causes as an Environmental Component
 6.5.2.2. Cause of Disease and Environmental Exposure 

6.5.3. Interaction between Components 

6.6. Data Collection and Analysis Strategy: Population Studies vs. Family Studies 

6.6.1. Population Studies 

 6.6.1.1. Evaluation of the Distribution of Traits in Populations 
 6.6.1.2. Identification of Risk Factors and their Importance 

6.6.2. Family Studies 

 6.6.2.1. Evaluation of Trait Distribution in Families 
 6.6.2.2. Identification of Risk Factors, Aggregation and their Importance 

6.6.3. Combining Population and Family Studies 

6.7. Data Collection Strategy and Analysis: Components of a Study of a Common Complex Disease 

6.7.1. Measuring Disease Burdens 

 6.7.1.1. Different Ways of Measuring Disease Burdens 

6.7.2. Morbidity Measures 

 6.7.2.1. Cumulative Incidence 
 6.7.2.2. Prevalence 
 6.7.2.3. Disease Duration 

6.8. Main Analytical Study Designs 

6.8.1. Cross-Sectional Design (Current Prevalence) 
6.8.2. Cohort Design (Prospective) 
6.8.2. Case-Control Design (Retrospective) 
6.8.3. Association Measures 

6.9. Data Analysis and Risk Calculations 

6.9.1. Association Measures 

 6.9.1.1. Relative Risk Estimates 
 6.9.1.2. Odds Ratio (OR)

6.9.2. Impact Measures 

 6.9.2.1. Attributable Risk (AR) 
 6.9.2.2. Population Attributable Risk (PAR) 

6.10. Estimates, Data Evaluation and Calculations in SPSS 

6.10.1. Estimates 
6.10.2. Assessment of Information 
6.10.3. SPSS Calculations

Module 7. Principal Investigators, Sponsors and Monitors of Veterinary Clinical Trials (VCTs) 

7.1. Professional Approach to Clinical Trials 

7.1.1. Business, Science and Clinical Trials 

 7.1.1.1. Clinical Trials in the Public and Private Sector
 7.1.1.2. Public-Private Preliminary Interaction 

7.2. Veterinary Profession in the Context of Clinical Trials 

7.2.1. Adequacy of the Veterinary Profession in Clinical Trials 
7.2.2. Reasons for Conducting Clinical Trials 
7.2.3. Registration and Animal Protection in Veterinary Clinical Trials 
7.2.4. Follow-Up Veterinary Care 

7.3. Principal Investigator's Guide 

7.3.1. Researchers and Companies Technical Assistance Companies

 7.3.1.1. Search Resources for Public and Private Companies 
 7.3.1.2. Budget Preparation Models 

7.3.2. Responsibilities and Regulatory Committees 

 7.3.2.1. Responsibilities of Technical Assistance Centers 
 7.3.2.2. PI Responsibilities 
 7.3.2.3. Other Participants with Responsibilities 

7.3.3. Budget Development and Negotiation

 7.3.3.1. Sponsors and their Types 
 7.3.3.2. Role of the Principal Investigator 
 7.3.3.3. Study Activation and Preliminary Reports 

7.4. The Research Equipment in Veterinary Clinical Trials I 

7.4.1. Research Equipment and Data Management 

 7.4.2.1. Principal Investigator 
 7.4.2.2. Other Research Participants 
 7.4.2.3. Clinical Trial Subjects 
 7.4.2.4. Databases: Management and Administration 

7.5. The Research Team and Data Quality Control II 

7.5.1. Data Sources 
7.5.2. Choice of Database Collection and Archiving System 
7.5.3. Data Quality Control 
7.5.4. Data Security Monitoring and Audits 

7.6. Good Clinical Practices, Protocol Agreement and Participant Evaluation 

7.6.1. Guarantees of Research Integrity and Protection of Participant's Security 
7.6.2. Timing of Data Management Plans 
7.6.3. Management of Research Personnel and Resources in Context 
7.6.4. Automated Systems 

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

7.7.1. Administration and Financial Management oVeterinary Population Involved in Biomedical Research 

7.8.1. Veterinary Population Involved in Biomedical Research 
7.8.2. Relevant Activity Areas 
7.8.3. Professional Merits 

7.9. Sponsors of Veterinary Clinical Trials 

7.9.1. Private Sector 
7.9.2. Foundations 
7.9.3. Other Promotion Sources

7.10. The Monitor: Training and Primary Function 

7.10.1. Monitor Training and Designation 

 7.10.1.1. Preparation, Attitude and Qualification 
 7.10.1.2. Sponsors 

7.10.2. Reporting Protocols and Forms 

 7.10.2.1. Protocol Reviews 
 7.10.2.2. Case Report Forms 
 7.10.2.3. Final Study Reports (According to VICH GL9 Competencies) 

7.10.3. Interaction with Researchers, Laboratories and Laboratory Personnel 

 7.10.3.1. IP Selection 
 7.10.3.2. Laboratory Selection 
 7.10.3.3. Location Selection

Module 8. Pharmacovigilance and Pharmacoeconomics 

8.1. Safety of Veterinary Medications in Animals 

8.1.1. Design and Implementation of the Pharmacovigilance System in a Clinical Trial 
8.1.2. Elaboration and Updating of Standard Operating Procedures (SOPs). 
8.1.3. Initial Assessment 

8.2. Personal Safety 

8.2.1. Active Substance Toxicity Data 
8.2.2. Toxicity Studies 
8.2.3. Exposure Scenarios 
8.2.4. Risk Management 

8.3. Environmental Safety 

8.3.1. Active Substance Metabolites 
8.3.2. Biodegradation 
8.3.3. Recommended Studies 

8.4. Adverse Event Management

8.4.1. Registration (Adverse Reactions, Side Effects and Expected Unfavorable Reactions) 
8.4.2. Control Methods 
8.4.3. Adverse Events Communication. 

8.5. Summary of Product Characteristics (SPC) for Veterinary Medication 
8.6. Elaboration and Maintenance of the Pharmacovigilance System Description 

8.6.1. Detailed Description of the Pharmacovigilance System 
8.6.2. Qualified Person Responsible for Pharmacovigilance (QPPV) 
8.6.3. Organization 
8.6.4. Databases 
8.6.5. Quality Management Systems 

8.7. Periodic Safety Reports (PSRs) 

8.7.1. VedDRA Code (Veterinary Dictionary for Regulatory Activities) 

8.8. Risk-Benefit Analysis 

8.8.1. Concept and Components 
8.8.2. Quantitative Methods 

 8.8.2.1. Relationship Between Benefit and Harm Impact Measures 
 8.8.2.2. Incremental Benefit-Risk Ratio 
 8.8.2.3. Multi-Criteria Analysis 

8.8.3. Cohort Simulation 

8.9. Crisis Management 

8.9.1. Risk Assessment 
8.9.2. Response Coordination 
8.9.3. Risk and Crisis Communication

8.10. Pharmacoeconomics 

8.10.1. Cost-Benefit Analysis 
8.10.2. Cost-Effectiveness Analysis 
8.10.3. Cost-Utility Analysis 
8.10.4. Cost Minimization 

Module 9. Legislation Applicable to Veterinary Clinical Trials 

9.1. European Legislation and Regulations I 

9.1.1. Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 Amending Regulation (EC) No. 726/2004 Laying Down Community Procedures for the Authorization and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency 
9.1.2. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on Veterinary Medicinal Products and Repealing Directive 2001/82/EC. 

9.2. European Legislation and Regulations II 

09.2.1. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying Down Community Procedures for the Authorization and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicinal Products Agency 

 9.2.1.1. Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 Concerning the Examination of Variations to the Terms of Marketing Authorizations for Medicinal Products for Human Use and Veterinary Medicinal Products. 

9.3. European Legislation and Regulations III 

9.3.1. Commission Regulation (EC) No. 1234/2008 of 24 November 2008 Concerning the Examination of Variations to the Terms of Marketing Authorizations for Medicinal Products for Human Use and Veterinary Medicinal Products 

9.4. European Regulations IV 
9.5. European Medicines Agency (EMA)

9.5.1. Organization 
9.5.2. Functions 

Module 10. Veterinary Clinical Trials II. Management, Start-ups and Commissioning 

10.1. Clinical Trial Management Preclinical Development 

10.1.1. Preclinical Development 

 10.1.1.1. Animal Experimentation Committees 

10.1.2. Exploratory Clinical Trial 
10.1.3. Regulatory Clinical Trial 

10.2. Clinical Trial Authorization Process 

10.2.1. Application for a Veterinary Research Product 
10.2.2. Request for a Veterinary Clinical Trial 

10.3. Documents at the Beginning of the Clinical Trial 

10.3.1. Contract Management 
10.3.2. Clinical Trial Protocol 

10.4. Clinical Trial Initiation and Start-Up 

10.4.1. Initial Visit and Center Opening 
10.4.2. Data Collection Notebooks (DCNs) 
10.4.3. Electronic Data Capture (EDC) 

10.5. Clinical Trial Documentation Archive 

10.5.1. Medication Shipment and Management 
10.5.2. Documentation Custody 

10.6. Final Report 

10.6.1. Center Closures 
10.6.2. Clinical Trial Documentation Audit 
10.6.3. Audit of Data Management Activities 

10.7. Laboratory Certification 

10.7.1. Laboratory Certification: GMP, GLP, ISO 
10.7.2. Pharmacopoeias 

10.8. Regulatory Dossier Structure 

10.8.1. Document Management
10.8.2. Validation of the Internal Structure 
10.8.3. Electronic Communication with Regulatory Agencies 

10.9. Writing Results

10.9.1. Publication of Clinical Trials in Scientific Journals 

10.10. CONSORT Recommendations

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