Why study at TECH?

Learn about the functions of a Principal Investigator, a Monitor and a Sponsor, to adapt your professional profile to the figure that most interests you" 

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In a Clinical Trial there are different figures that form a relevant part of the process, in addition to the Principal Investigator. The Sponsor who is in charge of bringing together the specialists who will carry out the study, as well as the Monitor, who is the link between this team and what is usually a development company, stand out. These professions are constantly on the rise and require in-depth and advanced specialization.

For this reason, TECH  has designed a Postgraduate certificate in Clinical Trials, Principal Investigator, Monitor and Sponsor, to provide students with the necessary skills and competencies to address these functions with total efficiency and specific knowledge. In this way, the contents delve into topics such as Study Design, Evidence-Based Veterinary Medicine, Ethical and Legal Regulations, the Research Team and Quality Control or Sponsors of Clinical Trials, among many other topics.

All this, in a comfortable 100% online mode that gives the student total freedom to organize their studies and schedules, without limitations of any kind. In addition, you can count on the most complete and up-to-date theoretical and practical content on the educational market, accessible from any device with an Internet connection.

Train your skills as a Monitor or Sponsor and achieve a promising future in one of the most promising areas in the veterinary field" 

This Postgraduate certificate in Clinical Trials, Principal Investigator, Monitor and Sponsor contains the most complete and up-to-date scientific program on the market. The most important features include:

  • The development of case studies presented by experts in Clinical Trial Principal Investigator, Monitor and Sponsor
  • 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

Thanks to its 100% online modality, the content will be available on the Virtual Campus from the beginning of the course, so you can enjoy it whenever you want"

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

Its multimedia content, developed with the latest educational technology, will allow the professional a situated and contextual learning, that is, a simulated environment that will provide an immersive training programmed to train in real situations.

The design of this program focuses on Problem-Based Learning, in which the professional will have to try to solve the different professional practice situations that will arise throughout the academic course. This will be done with the help of an innovative system of interactive videos made by renowned experts.

You will have all the information you need to delve into Protocols, Reports and Investigator Interaction"

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A program designed to help you achieve professional excellence in the veterinary environment"

Syllabus

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.

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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

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

Postgraduate Certificate in Clinical Trials, Principal Investigator, Monitor and Sponsor

If you are looking for an opportunity to specialize in clinical research and play a crucial role in the development of new treatments and drugs, our Postgraduate Certificate in Clinical Trials, Principal Investigator, Monitor and Sponsor is the ideal choice for you. At TECH Global University, we offer you the possibility of acquiring the skills and knowledge necessary to lead and manage clinical trials through our program of online classes. From anywhere in the world, you will be able to access this high quality Postgraduate Certificate and develop your career in clinical research. During this 1-3 month program, you will explore the fundamentals of clinical research and learn the key responsibilities of a principal investigator, clinical trial monitor and sponsor. Our team of highly qualified professionals and experts in the field will guide you through the essentials of clinical trial planning, execution, and analysis.

Become a Clinical Research Expert with TECH

At TECH, we pride ourselves on offering a practical and applied approach in our online classes. Through real-world case studies, simulations and interactive activities, you'll gain practical skills in clinical trial management, data collection and quality assurance in clinical research. Upon completion of this Postgraduate Certificate, you will become an expert in clinical trials, prepared to play a crucial role in medical research. You will gain a solid understanding of ethical and regulatory guidelines, as well as the skills necessary to lead a research team and ensure the validity of the results. You will also receive an internationally recognized certificate of completion, validating your skills and knowledge acquired during the program. This certificate will be a valuable credential in your career and will open doors in the field of clinical research.