Clinical Trials are essential for the development of new drugs, so pharmacists will find in this Postgraduate certificate the perfect complement for their specialization"

The main objective of this Postgraduate certificate is to educate pharmacists in the field of Clinical Trials. Thus, once this specialization has been completed, the student will have acquired the specific knowledge and skills that will allow them to participate in pharmacological research, contributing all their knowledge and achieving success in their profession. 

For this purpose, this educational program addresses the essential concepts to support the complexity at the methodological and semantic level of Clinical Trials, establishing the different categories of this work and giving great importance to the post-marketing research of the products. There will also be a focus on research drug samples and on the regulations in force in this area, with the aim of ensuring that all procedures are carried out in compliance with ethical, legal and good clinical practice standards.  

For the development of this Postgraduate certificate, TECH has a team of high-level professionals, who will offer their students all the experience of their work in research and teaching. All of this makes this Postgraduate certificate one of the most up to date and complete on the market, and offers the pharmacist a general overview of Clinical Trials, but with special and particular cases in which these investigations have been extremely important and beneficial. 

In addition, being 100% online, the student will decide from where and when to study, so that they can combine their study time with their work and private life, and using an innovative multimedia methodology that will make the theoretical part of this training more understandable.  

Expand your knowledge through this Postgraduate certificate that will allow you to specialize until you achieve excellence in this field"

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

The teaching staff includes professionals from the Health sector, who bring their experience to this training program, as well as 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 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 program. For this purpose, the professional will be assisted by an innovative interactive video system developed by renowned and experienced experts in the field of Clinical Trials.

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

This 100% online Postgraduate certificate will allow you to combine your studies with your professional work while increasing 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 certificate contains the most complete and up-to-date scientific program on the market”  

Module 1. Clinical Trials (I)

1.1. Clinical Trials. Fundamental Concepts I

1.1.1. Introduction
1.1.2. Definition of clinical trial (CT)
1.1.3. History of Clinical Trials
1.1.4. Clinical Research
1.1.5. Parties Involved in CTs
1.1.6. Conclusions

1.2. Clinical Trials. Fundamental Concepts II

1.2.1. Standards of Good Clinical Practice
1.2.2. Clinical Trial Protocol and Annexes
1.2.3. Pharmacoeconomic Assessment
1.2.4. Aspects that Could Be Improved in Clinical Trials

1.3. Clinical Trials Classification

1.3.1. Clinical Trials According to their Purpose
1.3.2. Clinical Trials According to the Scope of Research
1.3.3. Clinical Trials Methodology
1.3.4. Treatment Groups
1.3.5. Clinical Trials Masking
1.3.6. Treatment Assignment

1.4. Phase I Clinical Trials

1.4.1. Introduction
1.4.2. Phase I Clinical Trials Characteristics
1.4.3. Phase I Clinical Trials Design

 1.4.3.1. Single Dose Trials
 1.4.3.2. Multiple Dose Trials
 1.4.3.3. Pharmacodynamic Studies
 1.4.3.4. Pharmacokinetic Studies
 1.4.3.5. Bioavailability and Bioequivalence Studies

1.4.4. Phase I Units
1.4.5. Conclusions

1.5. Post-Authorization Studies Types of Design and Procedures

1.5.1. Concept
1.5.2. Justification and Objectives
1.5.3. Medical History
1.5.4. Classification According Objectives and Design

 1.5.4.1. Security/safety
 1.5.4.2. Drug Utilization Studies (DUS)
 1.5.4.3. Pharmacoeconomic Studies

1.5.5. Administrative Procedures for Observational Post-Authorization Studies (PAS)
1.5.6. Other Information of Interest
1.5.7. Conclusions

1.6. Equivalence and Non-Inferiority Cts (I)

1.6.1. Equivalence and Non-Inferiority Clinical Trials

 1.6.1.1. Introduction
 1.6.1.2. Justification
 1.6.1.3. Therapeutic Equivalence and Bioequivalence
 1.6.1.4. Concept of Therapeutic Equivalence and Non-Inferiority
 1.6.1.5. Objectives
 1.6.1.6. Basic Statistical Aspects
 1.6.1.7. Intermediate Data Tracking
 1.6.1.8. Quality of Equivalence and Non-Inferiority RCTs
 1.6.1.9. Ethical Aspects
 1.6.1.10. Post-Equivalence

1.6.2. Conclusions

1.7. Equivalence and Non-Inferiority CTs (II)

1.7.1. Therapeutic Equivalence in Clinical Practice

 1.7.1.1. Level 1: Direct Trials Between 2 Drugs, with Equivalence or Non-Inferiority Design
 1.7.1.2. Level 2: Direct Trials Between 2 Drugs, with Statistically Significant Differences, but without Clinical Relevance
 1.7.1.3. Level 3: Not Statistically Significant Trials
 1.7.1.4. Level 4: Different Trials vs. a Third Common Denominator
 1.7.1.5. Level 5: Trials vs. Different Comparators and Observational Studies
 1.7.1.6. Supporting Documentation: Reviews, Clinical Practice Guidelines, Recommendations, Expert Opinion, Clinical Judgment

1.7.2. Conclusions

1.8. Guidelines for the Development of a Clinical Trial Protocol

1.8.1. Summary
1.8.2. Index
1.8.3. General Information
1.8.4. Justification
1.8.5. Hypothesis and Objectives of the Trial
1.8.6. Trial Design
1.8.7. Selection and Withdrawal of Subjects
1.8.8. Treatment of Subjects
1.8.9. Efficacy Assessment
1.8.10. Safety Assessment

 1.8.10.1. Adverse Events
 1.8.10.2. Adverse Events Management
 1.8.10.3. Notification of Adverse Events

1.8.11. Statistics
1.8.12. Ethical Aspects
1.8.13. Information and Consent
1.8.14. Financing and Insurance
1.8.15. Publication Policy 
1.8.16. Conclusions

1.9. Non-Protocol Administrative Aspects of Clinical Trials 

1.9.1. Documentation Required for the Start of the Trial 
1.9.2. Subject Identification, Recruitment and Selection Records 
1.9.3. Source Documents
1.9.4. Data Collection Notebooks (DCNs) 
1.9.5. Monitoring 
1.9.6. Conclusions

1.10. Data Collection Notebooks (DCNs)

1.10.1. Definition
1.10.2. Function
1.10.3. Importance and Confidentiality
1.10.4. Types of Data Collection Notebooks
1.10.5. Elaboration of the Data Collection Notebook

 1.10.5.1. Types of Data
 1.10.5.2. Order
 1.10.5.3. Graphic Design
 1.10.5.4. Filling in the Data
 1.10.5.5. Recommendations

1.10.6. Conclusions

Module 2. Clinical Trials (II)

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

2.1.1. Manufacturing/Importation
2.1.2. Acquisition
2.1.3. Reception

 2.1.3.1. Shipment Verification
 2.1.3.2. Label Checking
 2.1.3.3. Shipment Confirmation
 2.1.3.4. Entry Registration

2.1.4. Custody/Storage

 2.1.4.1. Expiration Control
 2.1.4.2. Relabeling
 2.1.4.3. Temperature Control

2.1.5. Sample Prescription Request
2.1.6. Medical Prescription Validation
2.1.7. Dispensing

 2.1.7.1. Dispensing Procedure
 2.1.7.2. Checking Storage Conditions and Expiration Date
 2.1.7.3. Dispensing Act
 2.1.7.4. CheckOut

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

2.2.1. Preparation/Conditioning

 2.2.1.1. Introduction
 2.2.1.2. Current Legislation Regulations
 2.2.1.3. Exposure Routes and Handler Protection
 2.2.1.4. Centralized Preparation Unit
 2.2.1.5. Installations
 2.2.1.6. Individual Protection Equipment
 2.2.1.7. Closed Systems and Handling Equipment
 2.2.1.8. Technical Aspects of Preparation
 2.2.1.9. Cleaning Standards
 2.2.1.10. Waste Treatment in the Preparation Area
 2.2.1.11. Actions in Case of Spill and/or Accidental Exposure

2.2.2. Accounting/Inventory
2.2.3. Return/Destruction
2.2.4. Reports and Statistics

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

2.3.1. Visits Manager

 2.3.1.1. Preselection Visit
 2.3.1.2. Initiation Visit
 2.3.1.3. Monitoring Visit
 2.3.1.4. Audits and Inspections
 2.3.1.5. Closing Visit
 2.3.1.6. Archive

2.3.2. Member of the Ethics Committee
2.3.3. Clinical-Research Activity
2.3.4. Teaching Activity
2.3.5. Process Auditor

 2.3.5.1. Situation of the Hospital Pharmacy Service (HPS) and CT Units

2.3.6. Complexity of CTs
2.3.7. CTs as Sustainability the Health Care System

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

2.4.1. Basic Principles of Urologic Pathology Related to Clinical Trials

 2.4.1.1. Non-Oncologic Urologic Pathology

2.4.1.1.1. Benign Prostatic Hypertrophy
2.4.1.1.2. Urinary Infection
2.4.1.1.3. Erectile Dysfunction
2.4.1.1.4. Hypogonadism

 2.4.1.2. Oncologic Urologic Pathology

2.4.1.2.1. Bladder Tumors
2.4.1.2.2. Prostate Cancer

2.4.2. Background and Rationale for Clinical Trials in Urology

 2.4.2.1. Foundation
 2.4.2.2. Medical history
 2.4.2.3. Placebo Rationale
 2.4.2.4. Name and Mechanism of Action of the Investigational Product
 2.4.2.5. Conclusions from Previous Studies in Humans
 2.4.2.6. Benefits and Risks of Study Medication

2.4.2.6.1. Dosage and Administration
2.4.2.6.2. Medication Management Guidelines at Home
2.4.2.6.3. Overdosage/Infradosification

 2.4.2.7. Double-Blind/Open Study

2.4.3. Objectives and Assessment Criteria of the Study

 2.4.3.1. Study Objectives

2.4.3.1.1. Safety Objective
2.4.3.1.2. Exploratory Objectives

2.4.3.2. Study Evaluation Criteria

2.4.3.2.1. Main Efficacy Assessment Criteria
2.4.3.2.2. Secondary Efficacy Assessment Criteria

2.4.4. Research Plan
2.4.5. Preselection of Candidates for Clinical Trials
2.4.6. Study Procedures by Period

2.5. Clinical Trials in the Urology Service (II)

2.5.1. Patient Retention

 2.5.1.1. Post-Treatment Monitoring Visits
 2.5.1.2. Long-Term Monitoring Visits

2.5.2. Safety Assessments

 2.5.2.1. Adverse Effects Management
 2.5.2.2. SAEs Management
 2.5.2.3. Assigned Treatment Emergency Unblinding

2.5.3. Study Administration

 2.5.3.1. Dose-Limiting Toxicities
 2.5.3.2. Interrupting the Treatment

2.5.4. Researchers Obligations

 2.5.4.1. Regulatory Compliance and Ethics
 2.5.4.2. Informed Consent

2.5.5. Quality Control and Compliance

 2.5.5.1. Authorization of Subjects Protected Health Information
 2.5.5.2. Retention of Study Records and Files
 2.5.5.3. Data Collection Notebooks
 2.5.5.4. Protocol Amendments

2.5.6. Conclusions

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

2.6.1. Feasibility
2.6.2. Preselection Visit

 2.6.2.1. Main Investigators Role
 2.6.2.2. Logistics and Hospital Resources

2.6.3. Documentation
2.6.4. Initiation Visit
2.6.5. Source Document

 2.6.5.1. Patient’s Clinical History
 2.6.5.2. Hospital Reports

2.6.6. Vendors

 2.6.6.1. Interactive Web Response Systems (IWRS)
 2.6.6.2. Electronic Case Report Form (eCRF)
 2.6.6.3. Images
 2.6.6.4. Suspected Unexpected Serious Adverse Reactions (SUSARs)
 2.6.6.5. Accounting

2.6.7. Training
2.6.8. Delegation of Functions
2.6.9. Visit to Other Services Involved
2.6.10. Closing the Trial

2.7. General Information about Clinical Trials in Children and Adolescents

2.7.1. History of Clinical Trials in Children
2.7.2. Informed Consent

2.8. Clinical Trials in Adolescents

2.8.1. Adolescent Clinical Trials Practical Features
2.8.2. New Approaches to Adolescent Trials

2.9. Clinical Trials in Children

2.9.1. Specific Physiological Characteristics of the Child
2.9.2. Children Clinical Trials

2.10. Clinical Trials in Neonatal

2.10.1. Specific Physiological Characteristics the Neonatal
2.10.2. Neonatal Clinical Trials

This will provide key training to advance your career”