Update your knowledge and acquire new skills in Management and Administration of Veterinary Clinical Trials"

In order to carry out a Clinical Trial in the Veterinary field, multiple processes, procedures and protocols take place, which are the ones that allow this study of the characteristics and usefulness of a drug to be successful. This is why Management and Administration are so important in this area, as well as professionals with specific knowledge in this sector.

This is the reason why TECH has designed a Postgraduate diploma in Management and Administration of Veterinary Clinical Trials, to provide students with new and better skills with which to face their professional work, with full capacity and guaranteed success in their jobs. In this way, this program delves into topics such as the Scientific Method, Statistical Principles, Technical Documentation, Management, Special Standards or Evaluation Methods and response in Veterinary Clinical Trials.

All this, in a convenient 100% online mode that allows students to organize their schedules and studies as they see fit, without the need to travel and with the possibility of accessing all the content with any device with an Internet connection. In addition, with the most dynamic multimedia materials, the most complete information and the latest teaching technologies at your disposal.

Achieve excellence in Management and Administration in the veterinary environment"  

This Postgraduate diploma in Management and Administration of Veterinary Clinical Trials contains the most complete and up-to-date scientific program on the market. The most important features include:

• This Postgraduate Diploma in Management and Administration of Veterinary Clinical Trialscontains the most complete and up-to-date scientific program on the market. Its most notable features are:
• The development of case studies presented by experts in Management and Administration of Veterinary Clinical Trials
• 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 the self-assessment process can be carried out 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

The most comprehensive and innovative information on Management, Initiation and Start-up of Veterinary Clinical Trials"

The program's teaching staff includes professionals from the sector who contribute their work experience to this program, in addition to renowned specialists from leading societies and prestigious universities.

Its 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 an immersive education programmed to learn in real situations.

The design of this program focuses on Problem-Based Learning, by means of which the professional must try to solve the different professional practice situations that are presented throughout the academic course. For this purpose, the student will be assisted by an innovative interactive video system created by renowned experts.

You will be able to enjoy all the content available in the Virtual Campus from the first day and 100% online"

Hone your skills in Preclinical Development and Laboratory Certification"

This syllabus has been designed and structured by leading experts in the field, who have created a precise, innovative and complete content, with which the student's most demanding needs will be satisfied. In addition, all materials follow the Relearning pedagogical methodology, which facilitates the assimilation of essential concepts in a natural, direct and dynamic way.

Reach your highest goals in the workplace, thanks to TECH and the most efficient pedagogical methodology, 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. 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 The 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 Veterinary Clinical Trial I. Design and Methodology 

2.1. Veterinary Clinical Trials  

2.1.1. Veterinary Clinical Trial Research  
2.1.2. Conditions for Conducting a Veterinary Clinical Trial Investigation  
2.1.3. Types of Veterinary Clinical Trials   

2.1.3.1. Types of Trials According to the Study Design  
2.1.3.2. Parallelisms  
2.1.3.3. Crusader  
2.1.3.4. In Pairs  
2.1.3.5. Sequentials  

2.2. Identifying Sources of Information for a Veterinary Clinical Trial  

2.2.1. How To Find Information We Are Interested In  

2.2.1.1. Choice of Source  
2.2.1.2. Resources and Access Modes   
2.2.1.3. How to Search for the Best Evidence on a Topic  

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

2.3.1. General Information 
2.3.2. Justification and Objectives 
2.3.3. Test Outline 

2.4. Design of the Veterinary Clinical Trials   

2.4.1. Selection of Individuals  
2.4.2. Inclusion/Exclusion Criteria 
2.4.3. Treatment 
2.4.4. Destination of Study Animals, Products Derived from Study Animals and Products under Clinical Investigation and Control Products
2.4.5. Adverse Events (AEs)  

2.5. Methodology in Veterinary Clinical Trial Research   

2.5.1. Hypotheses  
2.5.2. Randomization  
2.5.3. City  
2.5.4. Sampling  
2.5.5. Uncontrolled Trials   
2.5.6. Controlled Trials  

2.5.6.1. Open
2.5.6.2. Blind  
2.5.6.3. Double-Blind  
2.5.6.4. Triple-Blind  
2.5.6.5. Pilot  

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

2.6.1. Discrimination Between CD in Humans and Animals  
2.6.2. Differences  
2.6.3. Implementation  
2.6.4. External and Internal Validity   
2.6.5. Variables  
2.6.6. Consent  
2.6.7. Reproducibility  
2.6.8. Risk  

2.7. Evaluation of the Efficiency of the Veterinary Clinical Trial

2.7.1. Statistics 
2.7.2. Records Management 
2.7.3. Annexes Attached to Protocol  
2.7.4. Changes in Protocol  
2.7.5. References 

2.8. Research Quality in a Veterinary Clinical Trial  

2.8.1. Legal Aspects    
2.8.2. Scientific Aspects      
2.8.3. Risk-Benefit Assessment  

2.9. Ethical Principles in a Veterinary Clinical Trial  

2.9.1. Historical Background  
2.9.2. Ethical Codes  
2.9.3. Application of Ethical Principles 

Module 3. The Veterinary Clinical Trials II. Management, Start-ups and Commissioning 

3.1. Clinical Trial Management Preclinical Development  

3.1.1. Preclinical Development 
3.1.1.1. Animal Experimentation Committees  
3.1.2. Exploratory Clinical Trial  
3.1.3. Regulatory Clinical Trial  

3.2. Clinical Trial Authorization Process  

3.2.1. Application for a Veterinary Research Product  
3.2.2. Request for a Veterinary Clinical Trial  

3.3. Documents at the Beginning of the Clinical Trial  

3.3.1. Contract Management  
3.3.2. Clinical Trial Protocol  
3.3.3. Informed Consent  

3.4. Clinical Trial Initiation and Start-Up  

3.4.1. Initial Visit and Center Opening  
3.4.2. Data Collection Notebooks (DCNs)  
3.4.3. Electronic Data Capture (EDC)  

3.5. Documentary Archive of a Clinical Trial  

3.5.1. Medication Shipment and Management  
3.5.2. Documentation Custody  

3.6. Final Report   

3.6.1. Center Closures  
3.6.2. Clinical Trial Documentation Audit  
3.6.3. Audit of Data Management Activities  

3.7. Laboratory Certification  

3.7.1. Laboratory Certification: GMP 
3.7.2. Laboratory Certification: GLP 
3.7.3. Laboratory Certification: ISO 

3.8. Regulatory Dossier Structure  

3.8.1. Document Management           
3.8.2. Validation of the Internal Structure  
3.8.3. Electronic Communication with Regulatory Agencies  

3.9. Results Writing  

3.9.1. Publication of Clinical Trials in Scientific Journals  

3.10. CONSORT Recommendations 

Module 4. The Veterinary Clinical Trials III. Treatment Trial

4.1. Description of Trail Treatment  

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

4.2. Application of Special Rules to the Trial Treatment  

4.2.1. Situations for Application of Special Rules to Trail Treatment  
4.2.2. Measures to Assess Therapeutic Compliance in Special Situations 
4.2.2.1. Examples of Special Situations  

4.3. Response to Treatment   

4.3.1. Data Collection  

4.4. Methods and Evaluation of Treatment Response   

4.4.1. Description of the Methods Used for Response Assessment and Quality Control 
4.4.1.1. Complementary Tests: Laboratory Tests, Diagnostic Imaging, Electrocardiogram, etc
4.4.2. Evaluation of Data Obtained as a Function of Response  

4.5. Monitoring. Trial Treatment Plan  

4.5.1. Monitoring Plan  
4.5.2. Research Timeline  
4.5.3. Types of Schedules  

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

4.6.1. Incorrect Documentation  
4.6.2. Samples 

4.6.2.1. Missing Samples  
4.6.2.2. Delayed Samples  
4.6.2.3. Forgotten Parameters  
4.6.2.4. Incorrect Sampling Times  
4.6.2.5. Laboratory Kit Problems 

4.7. Specialized Methodology in Treatment I  

4.7.1. Clinical Trials in Veterinary Oncology  
4.7.1.1. Trail Phases  
4.7.1.2. Therapeutic Targets  
4.7.1.3. Biological Sample
4.7.1.4. Bioequivalence 

4.8. Specialized Methodology in Treatment II 

4.8.1. Clinical Trials in Veterinary Infectious Pathology I  

4.8.1.1.  Analysis Objectives  
4.8.1.2.  Epidemiological Clinical Trials Methodology  

4.9. Specialized Methodology in Treatment III 

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

4.9.1.1. Prevention and Control of the Disease  

4.9.1.1.1. Institutional Strategies  

4.9.1.2. Risk Evaluation  

4.10. Specialized Methodology in Treatment IV 

4.10.1. Clinical Trials in Veterinary Neurology  

4.10.1.1. Neurology Research  

4.10.1.1.1. Research Areas  

4.10.1.2. Field Work  
4.10.1.3. Interpreting Results

This training will allow you to advance in your career in a comfortable way"