The current importance of pharmacological research makes this Postgraduate diploma an essential training for professionals in the sector"

Increased investment in research in the healthcare field to improve the quality of life of patients means that more and more professionals specialized in this field are needed. Hence the importance of broadening specialization in all research areas.

In this way, students will delve into the study of preclinical drug research, i.e., from the discovery of a molecule with therapeutic activity until it is marketed. Another very important part of this process is to know how to communicate new discoveries, which will allow further research in this field and promote its use. 

Additionally, the essential concepts to support the methodological and semantic complexity of clinical trials are addressed. As such, the categories according to which clinical trials are classified are established in order to delve into different types of clinical trials, such as Phase I trials, due to their great complexity, and post-marketing research of investigational products, due to their enormous involvement in pharmacovigilance processes. 

It should be noted that, within the clinical trial process, the figure of the pharmacists is of great importance, since they perform a series of essential tasks and responsibilities that guarantee the quality of the investigational drug samples.

All of the above makes this Postgraduate diploma one of the most up to date and complete programs on the market, and offers the healthcare professional a general overview of clinical trials, but with special and particular cases in which these investigations have proved to be extremely important and beneficial. 

Expand your knowledge through this Postgraduate diploma in Clinical Trials that will allow you to specialize until you achieve excellence in this field”

This Postgraduate diploma in Clinical Trials 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 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 development
• New developments in Clinical Trials.
• Practical exercises where the self assessment process can be carried out to improve learning
• Special emphasis on innovative methodologies in Clinical Trials
• 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

This Postgraduate diploma is the best investment you can make when selecting a refresher program, for two reasons: in addition to updating your knowledge in Clinical Trials, you will obtain a qualification endorsed by TECH Global University”

Its teaching staff includes professionals belonging to the healthcare field, who bring to this program the experience of their work, as well as renowned specialists from prestigious universities and reference societies.

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 learning programmed to train 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 throughout the scientific program. For this purpose, the professor will be assisted by an innovative interactive video system created by renowned and experienced experts in the field of Clinical Trials. 

Do not hesitate to take this program with us. You will find the best teaching material with virtual lessons"

This 100% online Postgraduate diploma will allow you to balance your studies with your professional work while expanding your knowledge in this field"

The structure of the contents has been designed by the best professionals in research and health, with an extensive background and recognized prestige in the profession, backed by the volume of cases reviewed, studied and diagnosed, and with extensive mastery of new technologies.

This Postgraduate diploma in Clinical Trials contains the most complete and up to date scientific program on the market” 

Module 1. Drug research and development

1.1. Development of New Drugs

1.1.1. Introduction
1.1.2. Development Phases of New Drugs
1.1.3. Discovery Phase
1.1.4. Preclinical Phase
1.1.5. Clinical Phase
1.1.6. Approval and Registration

1.2. Discovery of an Active Substance

1.2.1. Pharmacology
1.2.2. Seeding Trials
1.2.3. Pharmacological Interactions

1.3. Pharmacokinetics

1.3.1. Methods of Analysis
1.3.2. Absorption
1.3.3. Distribution
1.3.4. Metabolism
1.3.5. Excretion

1.4. Toxicology

1.4.1. Single Dose Toxicity
1.4.2. Repeated Dose Toxicity
1.4.3. Toxicokinetics
1.4.4. Carcinogenicity
1.4.5. Genotoxicity
1.4.6. Reproductive Toxicity
1.4.7. Tolerance
1.4.8. Dependency

1.5. Regulation of Drugs for Human Use

1.5.1. Introduction
1.5.2. Authorization Procedures
1.5.3. How a Drug is Evaluated: Authorization Dossier
1.5.4. Technical Data Sheet, Package Leaflet and EPAR
1.5.5. Conclusions

1.6. Pharmacovigilance

1.6.1. Pharmacovigilance in Development
1.6.2. Pharmacovigilance in Marketing Authorization
1.6.3. Post-authorization Pharmacovigilance

1.7. Uses in Special Situations

1.7.1. Introduction
1.7.2. Regulations
1.7.3. Examples:

1.8. From Authorization to Commercialization

1.8.1. Introduction
1.8.2. Drug Financing
1.8.3. Therapeutic Positioning Reports

1.9. Special Forms of Regulation

1.9.1. Advanced Therapies
1.9.2. Accelerated Approval
1.9.3. Biosimilars
1.9.4. Conditional Approval
1.9.5. Orphan Drugs

1.10. Dissemination of Research

1.10.1. Scientific Article
1.10.2. Types of Scientific Articles
1.10.3. Quality of Research Checklist
1.10.4. Drug Information Sources

Module 2. Clinical Trials (I)

2.1. Clinical Trials. Fundamental Concepts I

2.1.1. Introduction
2.1.2. Definition of clinical trial (CT)
2.1.3. History of Clinical Trials
2.1.4. Clinical Research
2.1.5. Parties Involved in CTs
2.1.6. Conclusions

2.2. Clinical Trials. Fundamental Concepts II

2.2.1. Standards of Good Clinical Practice
2.2.2. Clinical Trial Protocol and Annexes
2.2.3. Pharmacoeconomic Assessment
2.2.4. Aspects that Could Be Improved in Clinical Trials

2.3. Clinical Trials Classification

2.3.1. Clinical Trials Purpose
2.3.2. Clinical Trials According to the Scope of Research
2.3.3. Clinical Trials Methodology
2.3.4. Treatment Groups
2.3.5. Clinical Trials Masking
2.3.6. Treatment Assignment

2.4. Phase I Clinical Trials

2.4.1. Introduction
2.4.2. Phase I Clinical Trials Characteristics
2.4.3. Phase I Clinical Trials Design

2.4.3.1. Single Dose Trials
2.4.3.2. Multiple Dose Trials
2.4.3.3. Pharmacodynamic Studies
2.4.3.4. Pharmacokinetic Studies 
2.4.3.5. Bioavailability and Bioequivalence Studies

2.4.4. Phase I Units
2.4.5. Conclusions

2.5. Post-Authorization Studies Types of Design and Procedures

2.5.1. Concept
2.5.2. Justification and Objectives
2.5.3. Medical history
2.5.4. Classification According to Objectives and Design

2.5.4.1. Security/safety
2.5.4.2. Drug Utilization Studies (DUS)
2.5.4.3. Pharmacoeconomic Studies

2.5.5. Administrative Procedures for Observational Post-Authorization Studies (PAS)
2.5.6. Other Information of Interest
2.5.7. Conclusions

2.6. Equivalence and Non-Inferiority Cts (I)

2.6.1. Equivalence and Non-Inferiority Clinical Trials

2.6.1.1. Introduction
2.6.1.2. Justification
2.6.1.3. Therapeutic Equivalence and Bioequivalence
2.6.1.4. Concept of Therapeutic Equivalence and Non-Inferiority
2.6.1.5. Objectives
2.6.1.6. Basic Statistical Aspects
2.6.1.7. Intermediate Data Tracking
2.6.1.8. Quality of Equivalence and Non-Inferiority RCTs
2.6.1.9. Ethical Aspects
2.6.1.10. Post-Equivalence

2.6.2. Conclusions

2.7. Equivalence and Non-Inferiority CTs (II)

2.7.1. Therapeutic Equivalence in Clinical Practice

2.7.1.1. Level 1: Direct Trials Between 2 Drugs, with Equivalence or Non-Inferiority Design
2.7.1.2. Level 2: Direct Trials Between 2 Drugs, with Statistically Significant Differences, but without Clinical Relevance
2.7.1.3. Level 3: Not Statistically Significant Trials
2.7.1.4. Level 4: Different Trials vs. a Third Common Denominator
2.7.1.5. Level 5: Trials vs. Different Comparators and Observational Studies
2.7.1.6. Supporting Documentation: Reviews, Clinical Practice Guidelines, Recommendations, Expert Opinion, Clinical Judgment

2.7.2. Conclusions

2.8. Guidelines for the Development of a Clinical Trial Protocol

2.8.1. Summary
2.8.2. Index
2.8.3. General Information
2.8.4. Justification
2.8.5. Hypothesis and Objectives of the Trial
2.8.6. Trial Design
2.8.7. Selection and Withdrawal of Subjects
2.8.8. Treatment of Subjects
2.8.9. Efficacy Assessment
2.8.10. Safety Assessment

2.8.10.1. Adverse Events
2.8.10.2. Adverse Events Management
2.8.10.3. Adverse Events Notification
2.8.11. Statistics
2.8.12. Ethical Aspects
2.8.13. Information and Consent
2.8.14. Financing and Insurance
2.8.15. Publication Policy
2.8.16. Conclusions

2.9. Non-Protocol Administrative Aspects of Clinical Trials 

2.9.1. Documentation Required for the Start of the Trial 
2.9.2. Subject Identification, Recruitment and Selection Records 
2.9.3. Source Documents
2.9.4. Data Collection Notebooks (DCNs) 
2.9.5. Monitoring 
2.9.6. Conclusions

2.10. Data Collection Notebooks (DCNs)

2.10.1. Definition 
2.10.2. Function
2.10.3. Importance and Confidentiality
2.10.4. Types of Data Collection Notebooks
2.10.5. Elaboration of the Data Collection Notebook

2.10.5.1. Types of Data
2.10.5.2. Order
2.10.5.3. Graphic Design
2.10.5.4. Filling in the Data
2.10.5.5. Recommendations
2.10.6. Conclusions

Module 3. Clinical Trials (II)

3.1. Involvement of the Pharmacy Service in the Realization of Clinical Trials Sample Management (I)

3.1.1. Manufacturing/Importation
3.1.2. Acquisition
3.1.3. Reception

3.1.3.1. Shipment Verification
3.1.3.2. Label Checking
3.1.3.3. Shipment Confirmation
3.1.3.4. Entry Registration

3.1.4. Custody/Storage

3.1.4.1. Expiration Control
3.1.4.2. Relabeling
3.1.4.3. Temperature Control

3.1.5. Sample Prescription Request
3.1.6. Medical Prescription Validation
3.1.7. Dispensing

3.1.7.1. Dispensing Procedure
3.1.7.2. Checking Storage Conditions and Expiration Date
3.1.7.3. Dispensing Act
3.1.7.4. CheckOut

3.2. Involvement of the Pharmacy Service in the Realization of Clinical Trials Sample Management (II)

3.2.1. Preparation/Conditioning

3.2.1.1. Introduction
3.2.1.2.  Current Legislation Regulations
3.2.1.3. Exposure Routes and Handler Protection
3.2.1.4. Centralized Preparation Unit
3.2.1.5. Installations
3.2.1.6. Individual Protection Equipment
3.2.1.7. Closed Systems and Handling Equipment
3.2.1.8. Technical Aspects of Preparation
3.2.1.9. Cleaning Standards
3.2.1.10. Waste Treatment in the Preparation Area
3.2.1.11. Actions in Case of Spill and/or Accidental Exposure

3.2.2. Accounting/Inventory
3.2.3. Return/Destruction
3.2.4. Reports and Statistics

3.3. Involvement of the Pharmacy Service in the Realization of Clinical Trials Role of the Pharmacist

3.3.1. Visits Manager

3.3.1.1. Preselection Visit
3.3.1.2. Initiation Visit
3.3.1.3. Monitoring Visit
3.3.1.4. Audits and Inspections
3.3.1.5. Closing Visit
3.3.1.6. Archive

3.3.2. Member of the Ethics Committee
3.3.3. Clinical-Research Activity
3.3.4. Teaching Activity
3.3.5. Process Auditor
3.3.5.1. Situation of the Hospital Pharmacy Service (HPS) and CT Units
3.3.6. Complexity of CTs
3.3.7. CTs as Sustainability the Health Care System

3.4. Clinical Trials in the Hospital Urology Service (I)

3.4.1. Basic Principles of Urologic Pathology Related to Clinical Trials

3.4.1.1. Non-Oncologic Urologic Pathology

3.4.1.1.1. Benign Prostatic Hypertrophy
3.4.1.1.2 Urinary Infection
3.4.1.1.3. Erectile Dysfunction
3.4.1.1.4. Hypogonadisms

3.4.1.2. Oncologic Urologic Pathology

3.4.1.2.1. Bladder Tumors
3.4.1.2.2. Prostate Cancer

3.4.2. Background and Rationale for Clinical Trials in Urology

3.4.2.1. Foundation
3.4.2.2. Medical history
3.4.2.3. Placebo Rationale
3.4.2.4. Name and Mechanism of Action of the Investigational Product
3.4.2.5. Conclusions from Previous Studies in Humans
3.4.2.6. Benefits and Risks of Study Medication

3.4.2.6.1. Dosage and Administration
3.4.2.6.2. Medication Management Guidelines at Home
3.4.2.6.3. Overdosage/Infradosification

3.4.2.7. Double-Blind/Open Study

3.4.3. Objectives and Assessment Criteria of the Study

3.4.3.1. Study Objectives

3.4.3.1.1. Safety Objective
3.4.3.1.2. Exploratory Objectives

3.4.3.2 Assessment Criteria of the Study

3.4.3.2.1. Primary Efficacy Endpoints
3.4.3.2.2. Secondary Efficacy Assessment Criteria

3.4.4. Research Plan
3.4.5. Preselection of Candidates for Clinical Trials
3.4.6. Study Procedures by Period

3.5. Clinical Trials in the Urology Service (II)

3.5.1. Patient Retention

3.5.1.1. Post-Treatment Monitoring Visits
3.5.1.2. Longterm Monitoring Visits

3.5.2. Safety Assessments

3.5.2.1. Adverse Effects Management
3.5.2.2. SAEs Management
3.5.2.3. Assigned Treatment Emergency Unblinding

3.5.3. Study Administration

3.5.3.1. Dose-Limiting Toxicities
3.5.3.2. Interrupting the Treatment

3.5.4. Researchers Obligations

3.5.4.1. Regulatory Compliance and Ethics
3.5.4.2. Informed Consent

3.5.5. Quality Control and Compliance

3.5.5.1. Authorization of Subjects Protected Health Information
3.5.5.2. Retention of Study Records and Files
3.5.5.3. Data Collection Notebooks
3.5.5.4. Protocol Amendments

3.5.6. Conclusions

3.6. Approval of a Clinical Trial to the Urology Service Steps to Follow Trial Conclusion

3.6.1. Feasibility
3.6.2. Preselection Visit

3.6.2.1. Main Investigators Role
3.6.2.2. Logistics and Hospital Resources

3.6.3. Documentation
3.6.4. Initiation Visit
3.6.5. Source Document

3.6.5.1. Patient’s Clinical History
3.6.5.2. Hospital Reports

3.6.6. Vendors

3.6.6.1. Interactive Web Response Systems (IWRS)
3.6.6.2. Electronic Case Report Form (eCRF)
3.6.6.3. Images
3.6.6.4. Suspected Unexpected Serious Adverse Reactions (SUSARs)
3.6.6.4. Accounting

3.6.7. Training
3.6.8. Delegation of Functions
3.6.9. Visit to Other Services Involved
3.6.10. Closing the Trial

3.7. General Information about Clinical Trials in Children and Adolescents

3.7.1. History of Clinical Trials in Children
3.7.2. Informed Consent

3.8. Clinical Trials in Adolescents

3.8.1. Adolescent Clinical Trials Practical Features
3.8.2. New Approaches to Adolescent Trials

3.9. Clinical Trials in Children

3.9.1. Specific Physiological Characteristics of the Child
3.9.2. Children Clinical Trials

3.10. Clinical Trials in Neonatal

3.10.1. Specific Physiological Characteristics the Neonatal
3.10.2. Neonatal Clinical Trials

This will be a key specialization to advance your career"