The increase in investment in health research has favored an increase in the number of professionals who wish to develop in this field” 

This Postgraduate certificate in Clinical Trials for Nursing is designed to specialize professionals in this area in an essential aspect to find new treatments that allow the improvement of patients. The importance of this specialization is what has led TECHto design this comprehensive program, developed by a teaching team with years of experience in both clinical and research and teaching. 

Specifically, this 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. 

On the other hand, investigational drug samples are a critical point in the sequence of activities to be performed in the clinical trial. Therefore, to ensure that Clinical Trials are conducted according to ethical, legal and good clinical practice standards, it is necessary to establish a special sample control system that allows the use of samples according to the contents of the trial protocol. 

All of the above makes this Postgraduate certificate one of the most up to date and complete 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. 
In addition, being 100% online, the student will decide from where and when to study, so that they can balance their study time with their professional and private life, and using an innovative multimedia methodology that will make the theoretical part of this specialization 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 for Nursing 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 practice
• 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 work
• 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 in Clinical Trials, you will obtain a certificate issued by TECH"

The teaching staff includes professionals from the Health sector, who bring their experience to this educational 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. 

The design of this program focuses on problem-based learning, by means of which the healthcare professional must try to solve the different professional practice situations that arise throughout the academic 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 educational program 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 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 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 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. Non-commercial Research

1.5.1. Introduction

1.5.2. Start-up of Non-commercial Clinical Trials

1.5.3. Difficulties of the Independent Promoter

1.5.4. Promotion of Independent Clinical Research

1.5.5. Application for Grants for Non-commercial Clinical Research

1.5.6. Bibliography

1.6. Equivalence and Non-Inferiority EECC 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 EECC 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. Adverse Events Notification

1.8.11 Statistics

1.8.12 Ethical Aspects

1.8.13 Information and Consent

1.8.14. 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. Check Out

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. Exposure Routes and Handler Protection

2.2.1.3. Centralized Preparation Unit

2.2.1.4. Facilities

2.2.1.5. Individual Protection Equipment

2.2.1.6. Closed Systems and Handling Equipment

2.2.1.7. Technical Aspects of Preparation

2.2.1.8. Cleaning Standards

2.2.1.9. Waste Treatment in the Preparation Area

2.2.1.10. 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. Pre-selection 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

2.3.6. 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

3.4.1.1.1. Benign Prostatic Hypertrophy

2.4.1.1.2. Urinary Infection

3.4.1.1.3. Erectile Dysfunction

2.4.1.1.4. Hypogonadism

2.4.1.2. Oncologic Urologic Pathology

3.4.1.2.1. 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. Background

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

3.4.2.6.1. Dosage and Administration

2.4.2.6.2. Medication Management Guidelines at Home

3.4.2.6.3. 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

3.4.3.1.1. Safety Objective

2.4.3.1.2. Exploratory Objectives

2.4.3.2. Assessment Criteria of the Study

3.4.3.2.1. Main Efficacy Assessment Criteria

2.4.3.2.2. Secondary Efficacy Assessment Criteria

2.4.4. Research Plan

2.4.5. Pre-selection 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. Longterm 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

2.5.5. 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. Pre-selection 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. Education

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 education to advance in your career"