Improving the patient's quality of life is one of the objectives of healthcare and, to achieve this, we must make every effort in research"

The creation of new drugs allows us to survive new pathologies, diseases for which there are no effective treatments or which have shown resistance to existing drugs. Therefore, research in this field is essential to find effective drugs against the pathologies that affect human beings. In this case, TECH presents a very complete education on Clinical Trial Management and Monitoring for Nursing, since research is a multidisciplinary field that depends on different sectors. 

Research is a field that is growing every day, thanks to the efforts of public bodies and private institutions to invest in this field, achieving the appearance of successful drugs that allow the survival of patients fighting against diseases that until now had no cures or treatments that would allow them to improve their quality of life in the face of chronic illnesses. 

It is a multidisciplinary field in which professionals from different health fields participate. Therefore, in this case, TECH has designed this comprehensive program specifically for nurses, with the aim of acquiring specialized knowledge on Clinical Trials Management and Monitoring for Nursing, through a theoretical and practical education provided by professionals with extensive experience. 

The teaching team of this Professional Master's Degree has made a careful selection of topics, useful for experienced professionals working in the healthcare field. This program specializes the nurse in the field of clinical trials, being able to access the pharmaceutical industry field in the management and monitoring of clinical studies. 

In addition, this program includes the most advanced web 2.0 communication tools, which support working methods that encourage interaction among students, the exchange of information and constant and active participation. 

As it is an online program, the student is not constrained by fixed schedules or the need to move to another physical location, but rather, they can access the contents at any time of the day, allowing them to balance their professional or personal life with their academic life as they please. 

Expand your knowledge through this Professional master’s degree that will allow you to specialize until you achieve excellence in this field"

ThisProfessional master’s degree in MBA in Management and Monitoring of Clinical Trials for Nursing 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 self-assessment can be used 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 Professional master’s degree is the best investment you can make when selecting an up-to-date program for two reasons: In addition to updating your knowledge in MBA in Management and Monitoring of Clinical Trials for Nursing, you will obtain a degree from TECH Global University

The teaching staff includes professionals belonging to the field of health, who bring to this program the experience of their work, as well as recognized specialists from reference 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 is focused on Problem-Based Learning, so the healthcare professional must try to solve the different professional practice situations that arise throughout the academic program. To do so, the professional will be assisted by an innovative interactive video system developed by recognized experts in the field of Clinical Trials Management and Monitoring for Nursing, and with great experience. 

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

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

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 Professional master’s degree 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. Pre-clinical 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 Interventions

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. 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. Non-commercial Research

2.5.1. Introduction
2.5.2. Start-up of Non-commercial Clinical Trials
2.5.3. Difficulties of the Independent Promoter
2.5.4. Promotion of Independent Clinical Research
2.5.5. Application for Grants for Non-commercial Clinical Research
2.5.6. Bibliography

2.6. Equivalence and Non-Inferiority EECC 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. Post-Equivalence

2.6.2. Conclusions

2.7. Equivalence and Non-Inferiority EECC 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. Information and Consent
2.8.13. 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. Exposure Routes and Handler Protection
3.2.1.3. Centralized Preparation Unit
3.2.1.4. Facilities
3.2.1.5. Individual Protection Equipment
3.2.1.6. Closed Systems and Handling Equipment
3.2.1.7. Technical Aspects of Preparation
3.2.1.8. Cleaning Standards
3.2.1.9. Waste Treatment in the Preparation Area
3.2.1.10. 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
3.3.6. 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. Hypogonadism.

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. Background
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. Main Efficacy Assessment Criteria
 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. Quality Control and Compliance

3.5.4.1. Authorization of Subjects Protected Health Information
3.5.4.2. Retention of Study Records and Files
3.5.4.3. Data Collection Notebooks
3.5.4.4. Protocol Amendments

3.5.5. 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)
3.6.6.5. Accounting

3.6.7. Education
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

Module 4. Monitoring of Clinical Trials I

4.1. Promoter I

4.1.1. General Aspects
4.1.2. Promoter Responsibilities

4.2. Promoter II

4.2.1. Project Management
4.2.2. Non-commercial Research

4.3. Protocol

4.3.1. Definition and Content
4.3.2. Protocol Compliance

4.4. Monitoring

4.4.1. Introduction
4.4.2. Definition
4.4.3. Monitoring Objectives
4.4.4. Types of Monitoring: Traditional and Risk-Based

4.5. Clinical Trial Monitor I

4.5.1. Who can be a Monitor?
4.5.2. CRO: Clinical Research Organization
4.5.3. Monitoring Plan

4.6. The Monitor II

4.6.1. Monitors Responsibilities
4.6.2. Verification of Source Documents Source Documents Verification (SDV)
4.6.3. Monitors Report and Monitoring Letter

4.7. Selection Visit

4.7.1. Researcher Selection
4.7.2. Aspects to take into Account
4.7.3. Suitability of Facilities
4.7.4. Visit to other Hospital Services
4.7.5. Deficiencies in Study Facilities and Staffing

4.8. Start Up in a Clinical Research Center

4.8.1. Definition and Functionality
4.8.2. Essential Documents at the Beginning of the Trial

4.9. Initiation Visit

4.9.1. Objective
4.9.2. Preparing the Initiation Visit
4.9.3. Investigators File
4.9.4. Investigator Meeting

4.10. Initial Visit in Hospital Pharmacy

4.10.1. Objective
4.10.2. Investigational Drug Management
4.10.3. Temperature Control
4.10.4. General Deviation Procedure

Module 5. Monitoring of Clinical Trials II

5.1. Follow-Up Visit

5.1.1. Preparation

5.1.1.1. Letter Confirming the Visit
5.1.1.2. Preparation

5.1.2. Center Development

5.1.2.1. Documentation Review
5.1.2.2. SAE
5.1.2.3. Inclusion and Exclusion Criteria
5.1.2.4. Collate

5.1.3. Research Team Training

5.1.3.1. Monitoring

5.1.3.1.1. Monitoring Report Preparation
5.1.3.1.2. Issue Tracking
5.1.3.1.3. Team Support
5.1.3.1.4. Monitoring Letter

5.1.3.2. Temperature

5.1.3.2.1. Adequate Medication
5.1.3.2.2. Reception
5.1.3.2.3. Expiration
5.1.3.2.4. Dispensing
5.1.3.2.5. Setting Up
5.1.3.2.6. Return
5.1.3.2.7. Storage
5.1.3.2.8. Documentation

5.1.3.3. Samples

5.1.3.3.1. Local and Central
5.1.3.3.2. Types
5.1.3.3.3. Temperature Registration
5.1.3.3.4. Calibration/Maintenance Certificate

 5.1.3.4. Meeting with the Research Team

5.1.3.4.1. Signature of Pending Documentation
5.1.3.4.2. Discussion of Findings
5.1.3.4.3. Re-Training
5.1.3.4.4. Corrective Actions

5.1.3.5. Review of ISF (Investigator Site File)

5.1.3.5.1. Clinical Investigations (CIs) and Protocols
5.1.3.5.2. New Approvals from the Ethics Committee and the AEMPS
5.1.3.5.3. LOGs
5.1.3.5.4. Site Visit Letter
5.1.3.5.5. New Documentation

5.1.3.6. Suspected Unexpected Serious Adverse Reactions (SUSARs)

5.1.3.6.1. Concept
5.1.3.3.2. Principal Investigator Review

5.1.3.7. Electronic Notebook

5.2. Close-Out Visit

5.2.1. Definition
5.2.2. Reasons for Close-Out Visits

5.2.2.1. Completion of the Clinical Trial
5.2.2.2. Not Complying with Protocol
5.2.2.3. Not Complying with Good Clinical Practices
5.2.2.4. At the Investigators Request
5.2.2.5. Low Recruitment

5.2.3. Procedures and Responsibilities

5.2.3.1. Before the Close-Out Visit
5.2.3.2. During the Close-Out Visit
5.2.3.3. After the Close-Out Visit

5.2.4. Pharmacy Close-Out Visit
5.2.5. Final Report
5.2.6. Conclusions

5.3. Queries Management, Database Slicing

5.3.1. Definition
5.3.2. Queries Rules
5.3.3. How are Queries Generated?

5.3.3.1. Automatically
5.3.3.2. By the Monitor
5.3.3.3. By an External Reviewer

5.3.4. When are Queries Generated?

5.3.4.1. After a Monitoring Visit
5.3.4.2. Close to Closing a Database

5.3.5.  Query Status

5.3.5.1. Open
5.3.5.2. Pending Revision
5.3.5.3. Closed

5.3.6. Database Slicing

5.3.6.1. Most Frequent Database Slicing Errors

5.3.7. Conclusions

5.4. AE Management and SAE Notification

5.4.1. Definitions

5.4.1.1. Adverse Events Adverse Event (AE)
5.4.1.2. Adverse Reactions (AR)
5.4.1.3. Serious Adverse Event(SAE) or Serious Adverse Reaction (SAR)
5.4.1.4. Suspected Unexpected Serious Adverse Reaction (SUSAR)

5.4.2. Data to be Collected by the Researcher
5.4.3. Collection and Assessment of the Safety Data Obtained in the Clinical Trial

5.4.3.1. Description
5.4.3.2. Dates
5.4.3.3. Unraveling
5.4.3.4. Intensity
5.4.3.5. Actions Taken
5.4.3.6. Causal Relationship
5.4.3.7. Basic Questions

 5.4.3.7.1. Who Notifies, What is Notified, Who is Notified, How are they Notified, When are they Notified?

5.4.4. Procedures for the Communication of AE/AR with Investigational Drugs

 5.4.4.1. Expedited Notification of Individual Cases
 5.4.4.2. Periodic Security Reports
 5.4.4.3. Ad Hoc Safety Reports
 5.4.4.4. Annual Reports

5.4.5. Special Interest Events
5.4.6. Conclusions

5.5. Clinical Research Associate (CRA) Standard Operating Procedures Standard Operating Procedures (SOP)

5.5.1. Definition and Objectives
5.5.2. Writing a SOP

5.5.2.1. Procedure
5.5.2.2. Format
5.5.2.3. Implementation
5.5.2.4. Review

5.5.3. SOP Feasibility and Site Qualification Visit

5.5.3.1. Procedures

5.5.4. SOP Initiation Visit

5.5.4.1. Procedures Prior to the Initiation Visit
5.5.4.2. Procedures During the Initiation Visit
5.5.4.3. Monitoring Initiation Visit Procedures

5.5.5. SOP Monitoring Visit

5.5.5.1. Procedures Prior to the Monitoring Visit
5.5.5.2. Procedures During the Monitoring Visit
5.5.5.3. Monitoring Letter

5.5.6. SOP for Closing Visit

5.5.6.1. Preparing the Close-Out Visit
5.5.6.2. Manage the Close-Out Visit
5.5.6.3. Monitoring After a Close-Up Visit

5.5.7. Conclusions

5.6. Quality Guarantee Audits and Inspections

5.6.1. Definition
5.6.2. Types of Audits

5.6.2.1. Internal Audits
5.6.2.2. External Audits or Inspections

5.6.3. How Prepare an Audit
5.6.4. Principal Findings
5.6.5. Conclusions

5.7. Protocol Deviations

5.7.1. Criteria

5.7.1.1. Non-Compliance with Inclusion Criteria
5.7.1.2. Compliance with Exclusion Criteria

5.7.2. International Classification of Functioning (ICF) Deficiencies

5.7.2.1. Correct Signatures on Documents (CI, LOG)
5.7.2.2. Correct Dates
5.7.2.3. Correct Documentation
5.7.2.4. Correct Storage
5.7.2.5. Correct Version

5.7.3. Out-Of-Window Visits
5.7.4. Poor or Wrong Documentation
5.7.5. The 5 Rights Medication Administration

5.7.5.1. Right Patient
5.7.5.2. Right Drug
5.7.5.3. Right Time
5.7.5.4. Right Dose
5.7.5.5. Right Route

5.7.6. Missing Samples and Parameters

5.7.6.1. Missing Samples
5.7.6.2. Parameter Not Performed
5.7.6.3. Sample Not Sent On Time
5.7.6.4. Time of Sample Collection
5.7.6.6. Request for Kits Out of Time

5.7.7. Information Privacy

5.7.7.1. Information Security
5.7.7.2. Reporting Security
5.7.7.3. Photo Security

5.7.8. Temperature Deviations

5.7.8.1. Register
5.7.8.2. Inform.
5.7.8.3. Act

5.7.9. Open Blinding at the Wrong Time
5.7.10. PI Availability

5.7.10.1. Not Updated in Interactive Voice Response Services (IVRS)
5.7.10.2. Not Sent on Time
5.7.10.3. Not Registered on Time
5.7.10.4. Broken Stock

5.7.11. Forbidden Medication
5.7.12. Key and Non-Key

5.8. Source and Essential Documents

5.8.1. Features
5.8.2. Source Documents Location
5.8.3. Source Document Access
5.8.4. Source Document Types
5.8.5. How to Correct a Source Document
5.8.6. Source Document Retention Time
5.8.7. Main Components of the Medical History
5.8.8. Investigator's Brochure (IB)

5.9. Monitoring Plan

5.9.1. Visits
5.9.2. Frequency (F)
5.9.3. Organization
5.9.4. Confirmation
5.9.5. Site Issues Categorization
5.9.6. Communication with Researchers
5.9.7. Research Team Training
5.9.8. Trial Master File
5.9.9. Reference Documents
5.9.10. Electronic Notebooks Remote Review
5.9.11. Data Privacy
5.9.12. Center Management Activities

5.10. Data Collection Notebooks

5.10.1. Concept and History
5.10.2. Timeline Compliance
5.10.3. Data Validation
5.10.4. Management of Data Inconsistencies or Queries
5.10.5. Data Exports
5.10.6. Security and Roles
5.10.7. Traceability and Logs
5.10.8. Report Generation
5.10.9. Notifications and Alerts
5.10.10. Electronic Notebook Vs. Paper Notebook

Module 6. Coordination of Clinical Trials I

6.1. The Researcher’s File – General Aspects

6.1.1. What is the Researcher's File? What type of Documentation Should It Contain and Why? How Long Should the Information be Stored?

6.1.2. Contract

 6.1.2.1. Original Copies
 6.1.2.2. Amendments

6.1.3. Ethical Committees

 6.1.3.1. Approvals
 6.1.3.2. Amendments

6.1.4. Regulatory Authorities

 6.1.4.1. Approvals
 6.1.4.2. Modifications
 6.1.4.3. Monitoring and Final Reports

6.1.5. Civil Liability Insurance

6.2. Documentation Associated with the Research Team

6.2.1. CV
6.2.2. Good Clinical Practice Certificate
6.2.3. Specific Education Certificates
6.2.4. Signed Statement of the Investigator, Financial Disclosure
6.2.5. Task Delegation

6.3. Study Protocol and Monitoring

6.3.1. Protocol Versions, Summary and Pocket Guides
6.3.2. Protocol
6.3.3. Protocol Amendments
6.3.4. Protocol Signature Form

6.4. Patient Related Material

6.4.1. Patient Information Form and Informed Consent Form (Copies and Specimens for Signature)
6.4.2. Modifications to the Consent (Copies and Specimens for Signature)
6.4.3. Study Participation Cards
6.4.4. Information for Primary Care Physicians
6.4.5. Questionnaires

6.5. Patient Forms, Monitoring Visits

6.5.1. Patient (Screening)  Form
6.5.2. Patient Recruitment and Identification Form
6.5.3. Visit Logs and Reports Form

6.6. Data Collection Notebooks (DCNs)

6.6.1. Types
6.6.2. Guide or Manual for Data Entry in the DCN
6.6.3. Copy of DCN

6.7. Investigator's Brochure (Studies with Medical Devices) or Fact Sheet (Clinical Trials with Medication)

6.7.1. Investigators Brochure (IB)
6.7.2. Technical Data Sheets of the Drugs Under Study (If Marketed)
6.7.3. Instructions for the Control of Specific Parameters (example)
6.7.4. Instructions for Return of Medication or Medical Devices

6.8. Material Related to Laboratory and Specific Procedures

6.8.1. Central Laboratories and Sample Shipping Documents
6.8.2. Local Laboratory: Qualification Certificates and Ranks
6.8.3. Instructions for Acquiring and/or Processing Medical Images
6.8.4. Sample and Material Shipment

6.9. Security/Safety

6.9.1. Adverse Events and Serious Adverse Events
6.9.2. Notification Instructions
6.9.3. Relevant Security Correspondence

6.10. Others

6.10.1. Contact Information
6.10.2. Note to File
6.10.3. Correspondence with the Promoter
6.10.4. Acknowledgements of Receipt
6.10.5. Newsletter

Module 7. Coordination of Clinical Trials II

7.1. Research Team

7.1.1. Components of a Research Team

7.1.1.1. Principal Investigator
7.1.1.2. Sub-Investigator
7.1.1.3. Coordinator
7.1.1.4. Rest of the Team

7.1.2. Responsibilities of the Research Team

7.1.2.1. Compliance with Good Clinical Practices and Current Legislation
7.1.2.2. Compliance of the Study Protocol
7.1.2.3. Care and Maintenance of the Research Archive

7.1.3. Task Delegation

7.1.3.1. Document Details
7.1.3.2. Example

7.2. Trial Coordinator

7.2.1. Responsibilities

7.2.1.1. Primary Responsibilities
7.2.1.2. Secondary Responsibilities

7.2.2. Capabilities and Competencies

7.2.2.1. Academic Background
7.2.2.2. Skills

7.2.3. Clinical Trials vs. Observational Study

7.2.3.1. Types of Clinical Trials
7.2.3.2. Types of Observational Studies

7.3. Protocol

7.3.1. Primary and Secondary Objectives

7.3.1.1. What Are They and Who Defines Them?
7.3.1.2. Importance During the Course of the Clinical Trial

7.3.2. Inclusion and Exclusion Criteria

7.3.2.1. Inclusion Criteria
7.3.2.2. Exclusion Criteria
7.3.2.3. Example

7.3.3. Flowchart

7.3.3.1. Document and Explanation

7.3.4. Concomitant Medication and Prohibited Medication

7.3.4.1. Concomitant Drug
7.3.4.2. Forbidden Medication
7.3.4.3. Washout Periods

7.4. Documentation Required to Initiate Clinical Trial

7.4.1. Curriculum of the Research Team

7.4.1.1. Basic Notions of a Research Curriculum
7.4.1.2. Good Clinical Practice Example

7.4.2. Good Clinical Practice

7.4.2.1. Origin of Good Clinical Practices
7.4.2.2. How to Get Certified?
7.4.2.3. Expiration

7.4.3. Suitability of the Research Team

7.4.3.1. Who Signs the Document?
7.4.3.2. Presentation to Ethics Committee

7.4.4. Suitability of Facilities

7.4.4.1. Who Signs the Document?
7.4.4.2. Ethical Committee Presentation

7.4.5. Calibration Certificates

7.4.5.1. Calibration
7.4.5.2. Calibration Equipment
7.4.5.3. Valid Certifications
7.4.5.4. Expiration

7.4.6. Other Training

7.4.6.1. Necessary Certifications According Protocol

7.5. Main Functions Trial Coordinator

7.5.1. Documentation Preparation

7.5.1.1. Documentation Requested for Approval of the Study at the Center

7.5.2. Investigator Meeting

7.5.2.1. Importance
7.5.2.2. Attendees

7.5.3. Initiation Visit

7.5.3.1. Duties of the Coordinator
7.5.3.2. Functions of the Principal Investigator and Subinvestigators
7.5.3.3. Promoter
7.5.3.4. Monitor

7.5.4. Monitoring Visit

7.5.4.1. Preparation After a Monitoring Visit
7.5.4.2. Functions During the Monitoring Visit

7.5.5. End-Of-Study Visit

7.5.5.1. Storage of the Researchers File

7.6. Relationship with the Patient

7.6.1. Preparation of Visits

7.6.1.1. Consents and Amendments
7.6.1.2. Visit Window
7.6.1.3. Identify the Responsibilities of the Investigation Team during the Visit
7.6.1.4. Visit Calculator
7.6.1.5. Preparation of Documentation to be Used During the Visit

7.6.2. Complementary Tests

7.6.2.1. Analysis
7.6.2.2. Chest X-Ray
7.6.2.3. Electrocardiogram

7.6.3. Calendar of Visits

 7.6.3.1. Example

7.7. Samples

7.7.1. Equipment and Materials Necessary

7.7.1.1. Centrifuge
7.7.1.2. Incubator
7.7.1.3. Refrigerators

7.7.2. Processing of Samples

7.7.2.1. General Procedure
7.7.2.2. Example

7.7.3. Laboratory Kits

7.7.3.1. What Are They?
7.7.3.2. Expiration

7.7.4. Shipment of Samples

7.7.4.1. Sample Storage
7.7.4.2. Ambient Temperature Shipment
7.7.4.3. Shipping Frozen Samples

7.8. Data Collection Notebooks

7.8.1. What Is It?

7.8.1.1. Types of Notebooks
7.8.1.2. Paper Notebook
7.8.1.3. Electronic Notebook
7.8.1.4. Specific Notebooks According to Protocol

7.8.2. How To Complete It?

7.8.2.1. Example

7.8.3. Query

7.8.3.1. What Is a Query?
7.8.3.2. Resolution Time
7.8.3.3. Who Can Open a Query?

7.9. Randomization Systems

7.9.1. What Is It?
7.9.2. Types of IWRS:

7.9.2.1. Telephonics
7.9.2.2. Electronics

7.9.3. Responsibilities Researcher Vs. Research Team

7.9.3.1. Screening
7.9.3.2. Randomization
7.9.3.3. Scheduled Visits
7.9.3.4. Unscheduled Visits
7.9.3.5. Blinding Opening

7.9.4. Medication

7.9.4.1. Who Receives the Medication?
7.9.4.2. Drug Traceability

7.9.5. Return of Medication

7.9.5.1. Functions of the Research Team in the Return of Medication

7.10. Biological Treatments

7.10.1. Coordination of Clinical Trials with Biologics

7.10.1.1. Biological Treatments
7.10.1.2. Types of Treatment

7.10.2. Types of Studies

7.10.2.1. Biological Criteria Placebo
7.10.2.2. Biological Criteria Biological Criteria

7.10.3. Biological Management

7.10.3.1. Administration.
7.10.3.2. Traceability

7.10.4. Rheumatic Diseases

7.10.4.1. Rheumatoid Arthritis
7.10.4.2. Psoriatic Arthritis
7.10.4.3. Lupus
7.10.4.4. Scleroderma

Module 8. Follow-up of Patients in Clinical Trials

8.1. Patient Care in Outpatient Clinics

8.1.1. Visits in the Protocol

 8.1.1.1. Visits and Procedures
 8.1.1.2. Window of Realization of the Different Visits
 8.1.1.3. Database Considerations

8.2. Materials Used in the Different Study Visits

8.2.1. Questionnaires
8.2.2. Drug Adherence Cards
8.2.3. Symptom Cards
8.2.4. Study Card
8.2.5. Electronic Devices
8.2.6. Suicide Risk Scales
8.2.7. Material for the Displacement of Patients
8.2.8. Others

8.3. Strategies for Patient Retention:

8.3.1. Possible Causes for Abandonment of a Clinical Trial
8.3.2. Strategies and Solutions to the Possible Causes of Abandonment
8.3.3. Long-Term Monitoring of Patients Leaving the Study Prematurely

8.4. Loss of Patient Follow-Up:

8.4.1. Definition of Loss of Monitoring
8.4.2. Causes of Loss of Monitoring
8.4.3. Resumption of Monitoring

 8.4.3.1. Re-Inclusion Back into the Protocol

8.5. Adherence to Pharmacological Treatment under Study

8.5.1. Calculation of Adherence to Pharmacological Treatment
8.5.2. Risk Factors for Therapeutic Non-Compliance
8.5.3. Strategies to Strengthen Adherence to Treatment
8.5.4. Treatment Dropout
8.5.5. Study Drug Interactions

8.6. Follow-Up of Adverse Reactions, and Symptom Management in the Study Medication Intake

8.6.1. Study Medication

8.6.1.1. Different Drug Presentations
8.6.1.2. Procedure and Preparation of Study Medication

8.6.2. Drug-Related Adverse Reactions
8.6.3. Non-Drug Related Adverse Reactions
8.6.4. Adverse Reaction Treatment

8.7. Monitoring of Patient Attendance at Study Visits

8.7.1. Visit Calculator
8.7.2. Study Visits Control
8.7.3. Tools for Compliance and Visitor Control

8.8. Difficulties in Patient Monitoring Within a Clinical Trial

8.8.1. Problems Related to Adverse Patient Events
8.8.2. Problems Related to the Patients Work Situation
8.8.3. Problems Related to the Patients Residence
8.8.4. Problems Related to the Patients Legal Status
8.8.5. Solutions and their Treatments

8.9. Monitoring of Patients in Treatment with Psychopharmaceuticals
8.10. Monitoring of Patients During Hospitalization

Module 9. Biostatistics

9.1. Study Design

9.1.1. Research Question
9.1.2. Population to Analyze
9.1.3. Classification

9.1.3.1. Comparison between Groups
9.1.3.2. Maintenance of the Described Conditions
9.1.3.3. Assignment to Treatment Group
9.1.3.4. Degree of Masking
9.1.3.5. Modality of Intervention
9.1.3.6. Centers Involved

9.2. Types of Randomized Clinical Trials: Validity and Biases

9.2.1. Types of Clinical Trials

9.2.1.1. Superiority Study
9.2.1.2. Equivalence or Bioequivalence Study
9.2.1.3. Non-Inferiority Study

9.2.2. Analysis and Validity of Results

9.2.2.1. Internal Validity
9.2.2.2. External Validity

9.2.3. Biases

9.2.3.1. Selection
9.2.3.2. Measurement
9.2.3.3. Confusion

9.3. Sample Size Protocol Deviations

9.3.1. Parameters Used
9.3.2. Protocol Justification
9.3.3. Protocol Deviations

9.4.  Methodology

9.4.1. Missing Data Handling
9.4.2. Statistical Methods

 9.4.2.1. Description of Data
 9.4.2.2. Survival
 9.4.2.3. Logistic Regression
 9.4.2.4. Mixed Models
 9.4.2.5. Sensitivity Analysis
 9.4.2.6. Multiplicity Analysis

9.5. When Does the Statistician Become Part of the Project

9.5.1. Statistician Role

9.5.2. Points of the Protocol to be Reviewed and Described by the Statistician

 9.5.2.1. Study Design
 9.5.2.2. The Primary and Secondary Objectives of the Study
 9.5.2.3. Sample Size Calculation
 9.5.2.4. Variables
 9.5.2.5. Statistical Justification
 9.5.2.6. Material and Methods used to Study the Objectives of the Study

9.6. CRD Design

9.6.1. Information Gathering Variables Dictionary
9.6.2. Variables and Data Entry
9.6.3. Database Security, Testing and Debugging

9.7. Statistical Analysis Plan

9.7.1. What is a Statistical Analysis Plan?
9.7.2. When to Perform the Statistical Analysis Plan
9.7.3. Statistical Analysis Plan Parts

9.8. Intermediate Analysis

9.8.1. Reasons for an Early Stopping of a Clinical Trial
9.8.2. Implications of Early Termination of a Clinical Trial
9.8.3. Statistical Designs

9.9. Final Analysis

9.9.1. Final Report Criteria
9.9.2. Plan Deviations
9.9.3. Guidelines for the Elaboration of the Final Report of a Clinical Trial

9.10. Statistical Review of a Protocol

9.10.1. Checklist
9.10.2. Frequent Errors in the Review of a Protocol

Module 10. Leadership, Ethics and Social Responsibility in Companies 

10.1. Globalization and Governance 

10.1.1. Governance and Corporate Governance
10.1.2. The Fundamentals of Corporate Governance in Companies
10.1.3. The Role of the Board of Directors in  the Corporate Governance Framework

10.2. Leadership

10.2.1. Leadership A Conceptual Approach
10.2.2. Leadership in Companies
10.2.3. The Importance of Leaders in Business Management

10.3. Cross Cultural Management 

10.3.1. Cross Cultural Management Concept
10.3.2. Contributions to Knowledge of National Cultures
10.3.3. Diversity Management 

10.4. Management and Leadership Development 

10.4.1. Concept of Management Development
10.4.2. Concept of Leadership
10.4.3. Leadership Theories 
10.4.4. Leadership Styles
10.4.5. Intelligence in Leadership
10.4.6. The Challenges of Today’s Leader 

10.5. Business Ethics 

10.5.1. Ethics and Morality
10.5.2. Business Ethics
10.5.3. Leadership and Ethics in Companies 

10.6. Sustainability

10.6.1. Sustainability and Sustainable Development
10.6.2. The 2030 Agenda
10.6.3. Sustainable Companies 

10.7. Corporate Social Responsibility 

10.7.1. International Dimensions of Corporate Social Responsibility 
10.7.2. Implementing Corporate Social Responsibility 
10.7.3. The Impact and Measurement of Corporate Social Responsibility  

10.8. Responsible Management Systems and Tools 

10.8.1. CSR: Corporate Social Responsibility
10.8.2. Essential Aspects for Implementing a Responsible Management Strategy
10.8.3. Steps for the Implementation of a Corporate Social Responsibility Management System
10.8.4. CSR Tools and Standards

10.9. Multinationals and Human Rights 

10.9.1. Globalization, Multinational Companies and Human Rights 
10.9.2. Multinational Corporations and International Law
10.9.3. Legal Instruments for Multinationals in the Area of Human Rights

10.10. Legal Environment and Corporate Governance 

10.10.1. International Rules on Importation and Exportation
10.10.2. Intellectual and Industrial Property
10.10.3. International Labor Law 

Module 11. People and Talent Management 

11.1. Strategic People Management 

11.1.1. Strategic Human Resources Management
11.1.2. Strategic People Management 

11.2. Human Resources Management by Competencies 

11.2.1. Analysis of the Potential
11.2.2. Remuneration Policy
11.2.3. Career/Succession Planning 

11.3. Performance Evaluation and Performance Management

11.3.1. Performance Management
11.3.2. Performance Management: Objectives and Process 

11.4. Innovation in Talent and People Management 

11.4.1. Strategic Talent Management Models
11.4.2.  Talent Identification, Training and Development
11.4.3. Loyalty and Retention 
11.4.4. Proactivity and Innovation 

11.5. Motivation 

11.5.1. The Nature of Motivation
11.5.2. Expectations Theory
11.5.3. Needs Theory
11.5.4. Motivation and Financial Compensation

11.6. Developing High Performance Teams

11.6.1. High-Performance Teams: Self-Managed Teams 
11.6.2. Methodologies for the Management of High Performance Self-Managed Teams 

11.7. Change Management

11.7.1. Change Management
11.7.2. Type of Change Management Processes
11.7.3. Stages or Phases in the Change Management Process 

11.8. Negotiation and Conflict Management 

11.8.1. Negotiation 
11.8.2. Conflict Management 
11.8.3. Crisis Management 

11.9. Executive Communication

11.9.1. Internal and External Communication in the Corporate Environment 
11.9.2. Communication Departments 
11.9.3. The Person in Charge of Communication of the Company The Profile of the Dircom 

11.10. Productivity, Attraction, Retention and Activation of Talent 

11.10.1. Productivity 
11.10.2. Talent Attraction and Retention Levers 

Module 12. Economic and Financial Management 

12.1. Economic Environment

12.1.1. Macroeconomic Environment and the National Financial System
12.1.2. Financial Institutions
12.1.3. Financial Markets
12.1.4. Financial Assets
12.1.5. Other Financial Sector Entities

12.2. Executive Accounting

12.2.1. Basic Concepts
12.2.2. The Company’s Assets 
12.2.3. The Company’s Liabilities 
12.2.4. The Company’s Net Worth 
12.2.5. The Income Statement 

12.3. Information Systems and Business Intelligence

12.3.1. Fundamentals and Classification
12.3.2. Cost Allocation Phases and Methods
12.3.3. Choice of Cost Center and Impact

12.4. Budget and Management Control

12.4.1. The Budget Model 
12.4.2. The Capital Budget
12.4.3. The Operating Budget 
12.4.5. Treasury Budget 
12.4.6. Budget Monitoring  

12.5. Financial Management

12.5.1. The Company’s Financial Decisions 
12.5.2. Financial Department 
12.5.3. Cash Surpluses 
12.5.4. Risks Associated with Financial Management 
12.5.5. Financial Administration Risk Management 

12.6. Financial Planning

12.6.1. Definition of Financial Planning
12.6.2. Actions to be Taken in Financial Planning
12.6.3. Creation and Establishment of the Business Strategy 
12.6.4. The Cash Flow Table
12.6.5. The Working Capital Table

12.7. Corporate Financial Strategy

12.7.1. Corporate Strategy and Sources of Financing 
12.7.2. Financial Products for Corporate Financing 

12.8. Strategic Financing

12.8.1. Self-financing 
12.8.2. Increase in Equity 
12.8.3. Hybrid Resources 
12.8.4. Financing Through Intermediaries 

 12.9. Financial Analysis and Planning

12.9.1.  Analysis of the Balance Sheet
12.9.2. Analysis of the Income Statement
12.9.3. Profitability Analysis

12.10. Analyzing and Solving Cases/Problems

12.10.1. Financial Information on Industria de Diseño y Textil, S.A. (INDITEX) 

Module 13. Commercial and  Strategic Marketing Management 

13.1. Commercial Management
13.1.1. Conceptual Framework of Commercial Management
13.1.2. Business Strategy and Planning
13.1.3. The Role of Sales Managers

13.2. Marketing 

13.2.1. The Concept of Marketing
13.2.2. Basic Elements of Marketing
13.2.3. Marketing Activities of the Company

13.3. Strategic Marketing Management

13.3.1. The Concept of Strategic Marketing
13.3.2. Concept of Strategic Marketing Planning
13.3.3. Stages in the Process of Strategic Marketing Planning

13.4. Digital Marketing and e-Commerce

13.4.1. Digital Marketing and E-commerce Objectives 
13.4.2. Digital Marketing and Media Used 
13.4.3. E-Commerce General Context 
13.4.4. Categories of E-commerce 
13.4.5. Advantages and Disadvantages of E-commerce Versus Traditional Commerce. 

13.5. Digital Marketing to Reinforce a Brand

13.5.1. Online Strategies to Improve Your Brand’s Reputation
13.5.2. Branded Content and Storytelling  

13.6. Digital Marketing to Attract and Retain Customers 

13.6.1. Loyalty and Engagement Strategies through the Internet 
13.6.2. Visitor Relationship Management
13.6.3. Hypersegmentation

13.7. Managing Digital Campaigns

13.7.1. What is a Digital Advertising Campaign?
13.7.2. Steps to Launch an Online Marketing Campaign
13.7.3. Mistakes in Digital Advertising Campaigns

13.8. Sales Strategy 

13.8.1. Sales Strategy 
13.8.2. Sales Methods

13.9. Corporate Communication 

13.9.1. Concept
13.9.2. The Importance of Communication in the Organization 
13.9.3. Type of Communication in the Organization
13.9.4. Functions of Communication in the Organization
13.9.5. Elements of Communication 
13.9.6. Communication Problems 
13.9.7. Communication Scenarios  

13.10. Digital Communication and Reputation 

13.10.1. Online Reputation 
13.10.2. How to Measure Digital Reputation? 
13.10.3. Online Reputation Tools 
13.10.4. Online Reputation Report  
13.10.5. Online Branding 

Module 14. Executive  Management 

14.1. General Management 

14.1.1. The Concept of General Management 
14.1.2. The Role of the CEO 
14.1.3. The CEO and their Responsibilities
14.1.4. Transforming the Work of Management

14.2. Manager Functions: Organizational Culture and Approaches 

14.2.1. Manager Functions: Organizational Culture and Approaches 

14.3. Operations Management 

14.3.1. The Importance of Management
14.3.2. Value Chain 
14.3.3. Quality Management 

14.4. Public Speaking and Spokesperson Education

14.4.1. Interpersonal Communication 
14.4.2. Communication Skills and Influence 
14.4.3. Communication Barriers

14.5. Personal and Organizational  Communications Tools

14.5.1. Interpersonal Communication 
14.5.2. Interpersonal Communication Tools
14.5.3. Communication in the Organization
14.5.4. Tools in the Organization

14.6. Communication in Crisis Situations

14.6.1. Crisis
14.6.2. Phases of the Crisis
14.6.3. Messages: Contents and Moments

14.7. Preparation of a Crisis Plan 

14.7.1. Analysis of Possible Problems 
14.7.2. Planning
14.7.3. Adequacy of Personnel

14.8. Emotional Intelligence 

14.8.1. Emotional Intelligence and Communication
14.8.2. Assertiveness, Empathy, and Active Listening
14.8.3. Self-Esteem and Emotional Communication  

14.9. Personal Branding

14.9.1. Strategies for Personal Brand Development
14.9.2. Personal Branding Laws
14.9.3. Tools for Creating Personal Brands

14.10. Leadership and Team Management 

14.10.1. Leadership and Leadership Styles
14.10.2. Leader Capabilities and Challenges
14.10.3. Managing Change Processes
14.10.4. Managing Multicultural Teams

A unique education opportunity to advance your career"