In just 12 months you will be able to access the most relevant theoretical and practical information on drug development and research team coordination"

In recent years, the public and public administrations have become more aware of the importance of health research. As a result, there has been an increase in investment in this area, benefiting not only patients, who finally obtain effective drugs, but also the researchers themselves who wish to promote projects in different lines of study. 

In the current scenario, where work is being done to find more effective antibiotics, more effective vaccines or new pharmacological products, pharmacists are obliged to update their knowledge and keep abreast of the latest developments in clinical trials. Faced with this reality, this academic institution has created this Hybrid Master's Degree MBA in Clinical Trials Management and Monitoring, where the graduate will spend 12 months in an advanced and intensive program, developed by an excellent team of professionals specialized in this field.  

Thus, during this academic course, the professional will have access to a syllabus that offers a theoretical-practical perspective on advances in drug development, bioethics, clinical trials and biostatistics. For this purpose, innovative multimedia teaching resources (video summary of each topic, videos in detail), essential readings and simulations of clinical case studies will be used.

An online program in its theoretical framework, which is complemented by a practical stay in a leading clinical research center. In this real scenario, together with other professionals in the field, the graduate will be able to directly apply the updated concepts and enhance their competencies in Clinical Trial Management and Monitoring. 

In this way, the graduate will carry out a 3-week stay, where they will be able to integrate new methodologies, support research teams in their clinical trials, and, in short, obtain the most updated vision on team management and scientific methods used by the best professionals. A great opportunity to get an update in a specialized environment. 

TECH offers you an excellent opportunity to update your knowledge through the most advanced syllabus in Clinical Trial Management and Monitoring"

This Hybrid Master's Degree in MBA in Clinical Trials Management and Monitoring contains the most complete and up-to-date scientific program on the market. Its most notable features are:

• Development of more than 100 clinical cases presented by professionals in clinical trial management and monitoring
• Their graphic, schematic and eminently practical contents provide scientific information on the procedures that are essential for professional practice
• Presentation of practical workshops on clinical trials
• Algorithm-based interactive learning system for decision-making in the presented clinical situations
• Practical guidelines on approaching clinical trials
• Its special emphasis on evidence-based medicine and research methodologies for the conduct of clinical trials
• All of this will be complemented by 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
• In addition, an internship in one of the best research centers in the world will be offered

Take an intensive 3-week Postgraduate Certificate at a prestigious center and get the latest information on drug and medical device authorization procedures"

In this Professional Master's Degree, of a professionalizing nature and blended learning modality, the program is aimed at updating pharmaceutical professionals who work in research centers and who require a high level of qualification. The contents are based on the latest scientific evidence, and oriented in a didactic way to integrate theoretical knowledge into research practice, and the theoretical-practical elements will facilitate the updating of knowledge and allow decision making.

Thanks to its multimedia content developed with the latest educational technology, it will allow the pharmaceutical professional a situated and contextual learning, that is, a simulated environment that will provide an 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 program. For this purpose, the students will be assisted by an innovative interactive video system created by renowned and experienced experts.

This Hybrid Master's Degree MBA will bring you up to speed with the latest developments in clinical trial protocols and coordination"

Update your knowledge through the Hybrid Master's Degree MBA with an advanced syllabus, available 24 hours a day, from any electronic device with an Internet connection"

The syllabus for this program has been developed to provide the most relevant and up-to-date information on Clinical Trials Management and Monitoring. For this purpose, the professional will be provided with didactic resources, which will lead them to enter in a dynamic way into the research and development of drugs, the advances in the techniques and methods used in Clinical Trials, as well as the follow-up of the patient. In addition, thanks to the Relearning system, the graduate will be able to reduce the long hours of study and memorization. Once this phase is completed, the professional will enter an Internship Program, where he/she will directly expand his/her knowledge.

A study plan designed to offer you, in 12 months, the most advanced and recent content on Clinical Trials Management and Monitoring"

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 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. 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 According to their 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. Non-commercial Research
2.5.3. Start-up of Non-commercial Clinical Trials
2.5.4. Difficulties of the Independent Promoter
2.5.5. Promotion of Independent Clinical Research
2.5.6. Application for Grants for Non-commercial Clinical Research
2.5.7. Bibliography

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. Notification of Adverse Events

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

3.1.5.1. Medical Prescription Validation
3.1.5.2. Dispensing

3.1.5.2.1. Dispensing Procedure

3.1.5.3. Checking Storage Conditions and Expiration Date
3.1.5.4. Dispensing Act
3.1.5.5. 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. Facilities
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. 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 Hospital 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. (SUSAR)
3.6.6.5. Accounting

3.6.7. Education
3.6.8. Delegation of Functions
3.6.9. Visit to Other Services Involved
3.5.10. 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. Bioethics and Regulations

4.1. Basic Ethical Principles and Most Relevant Ethical Norms

4.1.1. Aims of Biomedical Science
4.1.2. Rights and Freedoms of Researchers
4.1.3. Limits to the Right of Research
4.1.4. Ethical Principles of Clinical Research
4.1.5. Conclusions

4.2. Ethical Evaluation of Clinical Research on Drugs and Medical Devices

4.2.1. Introduction
4.2.2. Areas of Bioethics

4.2.2.1. General Aspects
4.2.2.2. Research Ethics

4.2.3. Justification of Bioethics

4.2.3.1. Clinical Indeterminacy
4.2.3.2. Relevance of Scientific Objectives
4.2.3.3. Preclinical Data

4.2.4. Ethical Conditions of Clinical Trial Designs
4.2.5. Drug Research Ethics Committees

4.2.5.1. Definition
4.2.5.2. Functions
4.2.5.3. Composition
4.2.5.4. Conclusions

4.3. Subject Selection in Clinical Trials

4.3.1. Criteria
4.3.2. Special Patients and Vulnerability
4.3.3. Vulnerability Assessment

4.3.3.1. Age
4.3.3.2. Severity of Disease
4.3.3.3. Other Types of Vulnerability
4.3.3.4. Vulnerability Protection

4.3.4. Conclusions

4.4. Risk-Benefit Balance in Clinical Trials

4.4.1. Potential Benefits
4.4.2. Potential Risks
4.4.3. Minimizing Risks
4.4.4. Risk Level Assessment
4.4.5. Final Assessment of the Risk-Benefit Balance
4.4.6. Conclusions

4.5. Protection, Informed Consent and Participant Information Form

4.5.1. Participant Information Form (PIF)

4.5.1.1. Type of Information Provided
4.5.1.2. Information Processing

4.5.2. Informed Consent

4.5.2.1. Concepts
4.5.2.2. Obtaining Procedure
4.5.2.3. Clinical Trials with Minors
4.5.2.4. Clinical Trials with Patients with Modified Capacity to Give Consent
4.5.2.5. Clinical Trials in Emergency Situations
4.5.2.6. Clinical Trials in Pregnant or Breastfeeding Women
4.5.2.7. Clinical trials on the Disabled
4.5.2.8. Informed Consent for Genetic Studies
4.5.2.9. Insurance and Financial Compensation

4.5.2.9.1. Safety
4.5.2.9.2. Indemnification
4.5.2.9.3. Compensation

4.5.3. Confidentiality
4.5.4. Violations
4.5.5. Continuation of Treatment After the Trial
4.5.6. Conclusions

4.6. Good Clinical Practices in Clinical Trials

4.6.1. History
4.6.2. Legal and Ethical Framework
4.6.3. Guideline for Good Clinical Practice (GCP)

4.6.3.1. Basic Principles
4.6.3.2. Drug Research Ethics Committee (CEIM)
4.6.3.3. Researcher
4.6.3.4. Promoter
4.6.3.5. Protocol
4.6.3.6. Investigators Brochure (IB)
4.6.3.7. Promoters Manual
4.6.3.8. Essential Documents

4.6.4. Conclusions

4.7. Legislation on Clinical Trials with Drugs and Medical Devices

4.7.1. Introduction
4.7.2. European Legislation
4.7.3. FDA, EMA and AEMPS
4.7.4. Communication
4.7.5. Conclusions

4.8. Legislation on Clinical Trials with Healthcare Products

4.8.1. Introduction
4.8.2. Clinical Research with Medical Devices
4.8.3. European Legislation
4.8.4. Conclusions

4.9. Authorization and Registration Procedures for Drugs and Medical Devices

4.9.1. Introduction
4.9.2. Definitions
4.9.3. Drugs Authorization
4.9.4. Drugs Dispensing
4.9.5. Public Funding
4.9.6. Conclusions

4.10. Legislation on post-authorization studies

4.10.1. What are post-authorization trials?
4.10.2. Studies Justification
4.10.3. Classification

4.10.3.1. Security/Safety
4.10.3.2. Drug Utilization Studies (DUS)
4.10.3.3. Pharmacoeconomic Studies

4.10.4. Guidelines
4.10.5. Administrative Procedures
4.10.6. Conclusions

Module 5. Monitoring of Clinical Trials (I)

5.1. Promoter I

5.1.1. General Aspects
5.1.2. Promoter Responsibilities

5.2. Promoter II

5.2.1. Project Management
5.2.2. Non-commercial Research

5.3. Protocol

5.3.1. Definition and Content
5.3.2. Protocol Compliance

5.4. Monitoring

5.4.1. Introduction
5.4.2. Definition
5.4.3. Monitoring Objectives
5.4.4. Types of Monitoring: Traditional and Risk-Based

5.5. Clinical Trial Monitor I

5.5.1. Who can be a Monitor?
5.5.2. CRO: Clinical Research Organization
5.5.3. Monitoring Plan

5.6. The Monitor II

5.6.1. Monitors Responsibilities

5.7. Verification of Source Documents Source Documents Verification (SDV)
5.8. Monitors Report and Monitoring Letter

5.8.1. Selection Visit

5.8.1.1. Researcher Selection
5.8.1.2. Aspects to take into account
5.8.1.3. Suitability of Facilities
5.8.1.4. Visit to other Hospital Services
5.8.1.5. Deficiencies in Study Facilities and Staffing

5.8.2. Start Up in a clinical research center

5.8.2.1. Definition and Functionality
5.8.2.2. Essential Documents at the Beginning of the Trial

5.9. Initiation Visit

5.9.1. Objective
5.9.2. Preparing the Initiation Visit
5.9.3. Investigators File
5.9.4. Investigator Meeting

5.10. Initial Visit in Hospital Pharmacy

5.10.1. Objective
5.10.2. Investigational Drug Management
5.10.3. Controlling Temperature
5.10.4. General Deviation Procedure

Module 6. Monitoring of Clinical Trials (II)

6.1. Follow-Up Visit

6.1.1. Preparation

6.1.1.1. Letter Confirming the Visit
6.1.1.2. Preparation

6.1.2. Center Development

6.1.2.1 Documentation Review
6.1.2.2 SAE
6.1.2.3 Inclusion and Exclusion Criteria
6.1.2.4 Collate

6.1.3. Research Team Training

6.1.3.1 Monitoring

6.1.3.1.1. Monitoring Report Preparation
6.1.3.1.2. Issues Tracking
6.1.3.1.3. Team Support
6.1.3.1.4. Monitoring Letter

6.1.3.2 Temperature

6.1.3.2.1. Adequate Medication
6.1.3.2.2. Reception
6.1.3.2.3. Expiration
6.1.3.2.4. Dispensing
6.1.3.2.5. Setting Up
6.1.3.2.6. Return
6.1.3.2.7. Storage
6.1.3.2.8. Documentation

6.1.4. Samples

6.1.4.1. Local and Central
6.1.4.2. Types
6.1.4.3. Temperature Registration
6.1.4.4. Calibration/Maintenance Certificate
6.1.4.5. Meeting with the Research Team

6.1.4.5.1. Signature of Pending Documentation
6.1.4.5.2. Discussion of Findings
6.1.4.5.3. Retraining
6.1.4.5.4. Corrective Actions

6.1.4.6 Review of ISF (Investigator Site File)

6.1.4.6.1. Clinical Investigations (CIs) and Protocols
6.1.4.6.2. New Approvals from the Ethics Committee and the AEMPS
6.1.4.6.3. LOG
6.1.4.6.4. Site Visit Letter
6.1.4.6.5. New Documentation

6.1.4.7 Suspected Unexpected Serious Adverse Reactions (SUSARs)

6.1.4.7.1. Concept
6.1.4.7.2. Principal Investigator Review

6.1.4.8. Electronic Notebook

6.2. Close-Out Visit

6.2.1. Definition

6.2.1.1 Reasons for Close-Out Visits

6.2.1.1.1. Completion of the Clinical Trial
6.2.1.1.2. Not Complying with Protocol
6.2.1.1.3. Not Complying with Good Clinical Practices
6.2.1.1.4. At the Investigators Request
6.2.1.1.5. Low Recruitment

6.2.2. Procedures and Responsibilities

6.2.2.1 Before the Close-Out Visit
6.2.2.2 During the Close-Out Visit
6.2.2.3 After the Close-Out Visit

6.2.3. Pharmacy Close-Out Visit

6.2.3.1 Final Report
6.2.3.2 Conclusions

6.2.4. “Queries Management”, Database Slicing

6.2.4.1. Definition
6.2.4.2. Queries Rules
6.2.4.3. How are "Queries" generated?
6.2.4.4. Automatically
6.2.4.5. By the Monitor
6.2.4.6. By an External Reviewer

6.2.5. When are “Queries” Generated?

6.2.5.1. After a Monitoring Visit
6.2.5.2. Close to Closing a Database
6.2.5.3. Query Status
6.2.5.4. Open
6.2.5.5. Pending Revision
6.2.5.6. Closed
6.2.5.7. Database Slicing
6.2.5.8. Most Frequent Database Slicing Errors
6.2.5.9. Conclusions

6.3. AE Management and SAE Notification

6.3.1. Definitions

6.3.1.1. Adverse Events Adverse Event (AE)
6.3.1.2. Adverse Reactions (AR)
6.3.1.3. Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
6.3.1.4. Suspected Unexpected Serious Adverse Reaction (SUSAR) (SUSAR)

6.3.2. Data to be Collected by the Researcher

6.3.2.1. Collection and Assessment of the Safety Data Obtained in the Clinical Trial
6.3.2.2. Description

6.3.2.2.1. Dates
6.3.2.2.2. Unraveling
6.3.2.2.3. Intensity
6.3.2.2.4. Actions Taken
6.3.2.2.5. Causality Relationship
6.3.2.2.6. Basic Questions

6.3.2.3. Who notifies, what is notified, to whom is it notified, how is it notified,  when is it notified?

6.3.2.3.1. Procedures for the communication of AA/RA with investigational drugs
6.3.2.3.2. Expedited Notification of Individual Cases
6.3.2.3.3. Periodic Security Reports
6.3.2.3.4. “Ad hoc" Security Reports
6.3.2.3.5. Annual Reports

6.3.2.4. Special Interest Events
6.3.2.5. Conclusions

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

6.4.1. Definition and objectives

6.4.1.1. Writing a SOP
6.4.1.2. Procedure
6.4.1.3. Format
6.4.1.4. Implementation
6.4.1.5. Review

6.4.2. SOP Feasibility and Site Qualification Visit

6.4.2.1. Procedures
6.4.2.2. Visit home
6.4.2.3. Procedures Prior to the Initiation Visit
6.4.2.4. Procedures During the Initiation Visit
6.4.2.5. Monitoring Initiation Visit Procedures

6.4.3. Monitoring Visit 

6.4.3.1. Procedures Prior to the Monitoring Visit 
6.4.3.2. Procedures During the Monitoring Visit 
6.4.3.3. Monitoring Letter 

6.4.4. SOP for Close-Out Visit 

6.4.4.1. Preparing the Close-Out Visit 
6.4.4.2. Manage the Close-Out Visit 
6.4.4.3. Monitoring After a Close-Up Visit 

6.4.5. Conclusions

6.5. Quality Guarantee Audits and Inspections

6.5.1. Definition
6.5.2. Types of Audits

6.5.2.1. Internal Audits
6.5.2.2. External Audits or Inspections

6.5.3. How to Prepare an Audit

6.5.3.1. Principal Findings

6.5.4. Conclusions

6.6. Protocol Deviations

6.6.1. Criteria

6.6.1.1. Non-Compliance with Inclusion Criteria
6.6.1.2. Compliance with Exclusion Criteria

6.6.2. International Classification of Functioning (ICF) Deficiencies

6.6.2.1. Correct Signatures on Documents (CI, LOG)
6.6.2.2. Correct Dates
6.6.2.3. Correct Documentation
6.6.2.4. Correct Storage
6.6.2.5. Correct Version

6.7. Out-Of-Window Visits 

6.7.1. Poor or Wrong Documentation 
6.7.2. The 5 Rights Medication Administration 

6.7.2.1. Right Patient 
6.7.2.2. Right Drug 
6.7.2.3. Right Time 
6.7.2.4. Right Dose 
6.7.2.5. Right Route 

6.8. Missing Samples and Parameters 

6.8.1. Missing Samples 
6.8.2. Parameter Not Performed 
6.8.3. Sample Not Sent On Time 
6.8.4. Time of Sample Collection 
6.8.5. Request for Kits Out of Time 
6.8.6. Information Privacy 

6.8.6.1. Information Security 
6.8.6.2. Reporting Security 
6.8.6.3. Photo Security 

6.8.7. Temperature Deviations 

6.8.7.1. Register 
6.8.7.2. Inform
6.8.7.3. Act 

6.8.8. Open Blinding at the Wrong Time 
6.8.9. PI Availability 

6.8.9.1. Not Updated in Interactive Voice Response Services (IVRS) 
6.8.9.2. Not Sent on Time 
6.8.9.3. Not Registered on Time 
6.8.9.4. Broken Stock 

6.8.10. Forbidden Medication 
6.8.11. Key and Non-Key 

6.9. Source and Essential Documents 

6.9.1. Features 
6.9.2. Source Documents Location 
6.9.3. Source Document Access 
6.9.4. Source Document Types 
6.9.5. How to Correct a Source Document 
6.9.6. Source Document Retention Time 
6.9.7. Main Components of the Medical History 
6.9.8. Investigator's Brochure (IB) 

6.10. Monitoring Plan 

6.10.1. Visits 
6.10.2. Frequency (F) 
6.10.3. Organisation 
6.10.4. Confirmation 
6.10.5. Site Issues Categorization 
6.10.6. Communication with Researchers 
6.10.7. Research Team Training 
6.10.8. Trial Master File 
6.10.9. Reference Documents 
6.10.10. Electronic Notebooks Remote Review 
6.10.11. Data Privacy 
6.10.12. Center Management Activities 

6.11. Data Collection Notebooks 

6.11.1. Concept and History 
6.11.2. Timeline Compliance 
6.11.3. Data Validation 
6.11.4. Management of Data Inconsistencies or “Queries” 
6.11.5. Data Exports 
6.11.6. Security and Roles 
6.11.7. Traceability and Logs 
6.11.8. Report Generation 
6.11.9. Notifications and Alerts 
6.11.10. Electronic Notebook vs. Paper Notebook 

Module 7. Coordination of Clinical Trials (I)

7.1. The Researcher’s File – General Aspects

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

7.1.2.1. Original Copies
7.1.2.2. Amendments

7.1.3. Ethical Committees

7.1.3.1. Approvals
7.1.3.2. Amendments

7.1.4. Regulatory Authorities

7.1.4.1. Approvals
7.1.4.2. Modifications
7.1.4.3. Monitoring and Final Reports

7.1.5. Civil Liability Insurance

7.2. Documentation Associated with the Research Team

7.2.1. CV
7.2.2. Good Clinical Practice Certificate
7.2.3. Specific Education Certificates
7.2.4. Signed Statement of the Investigator, ”Financial Disclosure”
7.2.5. Task Delegation

7.3. Study Protocol and Monitoring

7.3.1. Protocol Versions, Summary and Pocket Guides
7.3.2. Protocol
7.3.3. Protocol Amendments
7.3.4. Protocol Signature Form

7.4. Patient Related Material

7.4.1. Patient Information Form and Informed Consent Form (Copies and Specimens for Signature)
7.4.2. Modifications to the Consent (Copies and Specimens for Signature)
7.4.3. Study Participation Cards
7.4.4. Information for Primary Care Physicians
7.4.5. Questionnaires

7.5. Patient Forms, Monitoring Visits

7.5.1. Patient (Screening)  Form
7.5.2. Patient Recruitment and Identification Form
7.5.3. Visit Logs and Reports Form

7.6. Data Collection Notebooks (DCNs)

7.6.1. Types
7.6.2. Guide or Manual for Data Entry in the DCN
7.6.3. Copy of DCN

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

7.7.1. Investigators Brochure (IB)
7.7.2. Technical Data Sheets of the Drugs Under Study (If Marketed)
7.7.3. Instructions for the Control of Specific Parameters (e.g. Temperature)
7.7.4. Instructions for Return of Medication or Medical Devices

7.8. Material Related to Laboratory and Specific Procedures

7.8.1. Central Laboratories and Sample Shipping Documents
7.8.2. Local Laboratory: Qualification Certificates and Ranks
7.8.3. Instructions for Acquiring and/or Processing Medical Images
7.8.4. Sample and Material Shipment

7.9. Security/Safety

7.9.1. Adverse Events and Serious Adverse Events
7.9.2. Notification Instructions
7.9.3. Relevant Security Correspondence

7.10. Others

7.10.1. Contact Information
7.10.2. “Note to File”
7.10.3. Correspondence with the Promoter
7.10.4. Acknowledgements of Receipt
7.10.5. Newsletter

Module 8. Coordination of Clinical Trials (II)

8.1. Research Team

8.1.1. Components of a Research Team
8.1.2.  Principal Investigator
8.1.3. Sub-Investigator
8.1.4. Coordinator
8.1.5. Rest of the Team

8.2. Responsibilities of the Research Team

8.2.1. Compliance with Good Clinical Practices and Current Legislation
8.2.2. Compliance of the Study Protocol
8.2.3. Care and Maintenance of the Research Archive

8.3. Task Delegation

8.3.1. Document Details
8.3.2. Example

8.4. Trial Coordinator

8.4.1. Responsibilities

8.4.1.1. Primary Responsibilities
8.4.1.2. Secondary Responsibilities

8.4.2. Capabilities and Competencies

8.4.2.1. Academic Background
8.4.2.2. Competencies

8.4.3. Clinical Trials vs. Observational Study

8.4.3.1. Types of Clinical Trials
8.4.3.2. Types of Observational Studies

8.5. Protocol

8.5.1. Primary and Secondary Objectives

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

8.5.2. Inclusion and Exclusion Criteria

8.5.2.1. Inclusion Criteria
8.5.2.2. Exclusion Criteria
8.5.2.3. Example

8.5.3. Flowchart

8.5.3.1. Document and Explanation

8.5.4. Concomitant Medication and Prohibited Medication

8.5.4.1. Concomitant Drug
8.5.4.2. Forbidden Medication
8.5.4.3. Washout Periods

8.5.5. Documentation Required to Initiate Clinical Trial

8.5.5.1. Curriculum of the Research Team
8.5.5.2. Basic Notions of a Research Curriculum
8.5.5.3. Good Clinical Practice Example

8.5.6. Good Clinical Practice

8.5.6.1. Origin of Good Clinical Practices
8.5.6.2. How to Get Certified?
8.5.6.3. Expiration

8.5.7. Suitability of the Research Team

8.5.7.1. Who Signs the Document?
8.5.7.2. Presentation to Ethics Committee

8.5.8. Suitability of Facilities

8.5.8.1. Who Signs the Document?
8.5.8.2. Ethical Committee Presentation

8.5.9. Calibration Certificates

8.5.9.1. Calibration
8.5.9.2. Calibration Equipment
8.5.9.3. Valid Certifications
8.5.9.4. Expiration

8.5.10. Other Training

8.5.10.1. Necessary Certifications According Protocol

8.5.11. Main Functions Trial Coordinator

8.5.11.1. Documentation Preparation
8.5.11.2. Documentation Requested for Approval of the Study at the Center

8.5.12. Investigator Meeting

8.5.12.1 Importance
8.5.12.2 Attendees
8.5.12.3 Initiation Visit

8.5.12.3.1. Duties of the Coordinator
8.5.12.3.2. Functions of the Principal Investigator and Subinvestigators
8.5.12.3.3. Promoter
8.5.12.3.4. Monitor

8.5.13. Monitoring Visit

8.5.13.1. Preparation After a Monitoring Visit
8.5.13.2. Functions During the Monitoring Visit

8.5.14. End-Of-Study Visit

8.5.14.1. Storage of the Researchers File

8.6. Relationship with the Patient

8.6.1. Preparation of Visits

8.6.1.1. Consents and Amendments
8.6.1.2. Visit Window

8.6.2. Identify the Responsibilities of the Investigation Team during the Visit

8.6.2.1. Visit Calculator
8.6.2.2. Preparation of Documentation to be Used During the Visit

8.7. Complementary Tests

8.7.1. Analysis
8.7.2. Chest X-Ray
8.7.3. Electrocardiogram
8.7.4. Calendar of Visits
8.7.5. Example
8.7.6. Samples

8.7.6.1 Equipment and Materials Necessary

8.7.6.1.1. Centrifuge
8.7.6.1.2. Incubator
8.7.6.1.3. Refrigerators

8.7.6.2 Processing of Samples

8.7.6.2.1. General Procedure
8.7.6.2.2. Example

8.7.6.3 Laboratory Kits

8.7.6.3.1. What are they?
8.7.6.3.2.Caducidad

8.7.6.4. Shipment of Samples

8.7.6.4.1. Sample Storage
8.7.6.4.2. Ambient Temperature Shipment
8.7.6.4.3. Shipping Frozen Samples

8.8. Data Collection Notebooks

8.8.1. What Is It?

8.8.1.1. Types of Notebooks
8.8.1.2. Paper Notebook
8.8.1.3. Electronic Notebook
8.8.1.4. Specific Notebooks According to Protocol

8.8.2. How To Complete It?

8.8.2.1 Example

8.8.3. Query

8.8.3.1. What Is a Query?
8.8.3.2. Resolution Time
8.8.3.3. Who Can Open a Query?

8.9. Randomization Systems

8.9.1. What Is It?
8.9.2. Types of IWRS

8.9.2.1. Telephonics
8.9.2.2. Electronics

8.9.3. Responsibilities Researcher vs. Research Team

8.9.3.1. Screening
8.9.3.2. Randomization
8.9.3.3. Scheduled Visits
8.9.3.4. Unscheduled Visits
8.9.3.5. Blinding Opening

8.9.4. Medication

8.9.4.1. Who Receives the Medication?
8.9.4.2. Drug Traceability

8.9.5. Return of Medication

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

8.10. Biological Treatments

8.10.1. Coordination of Clinical Trials with Biologicals

8.10.1.1. Biological Treatments
8.10.1.2. Types of Treatment

8.10.2. Types of Studies

8.10.2.1. Biological Criteria Placebo
8.10.2.2. Biological Criteria Biological Criteria

8.10.3. Biological Management

8.10.3.1. Administration
8.10.3.2. Traceability

8.10.4. Rheumatic Diseases

8.10.4.1. Rheumatoid Arthritis
8.10.4.2. Psoriatic Arthritis
8.10.4.3. Lupus
8.10.4.4. Scleroderma

Module 9. Follow-up of Patients in Clinical Trials

9.1. Patient Care in Outpatient Clinics

9.1.1. Visits in the Protocol

9.1.1.1. Visits and Procedures
9.1.1.2. Window of Realization of the Different Visits
9.1.1.3. Database Considerations

9.2. Materials Used in the Different Study Visits

9.2.1. Questionnaires
9.2.2. Drug Adherence Cards
9.2.3. Symptom Cards
9.2.4. Study Card
9.2.5. Electronic Devices
9.2.6. Suicide Risk Scales
9.2.7. Material for the Displacement of Patients
9.2.8. Others

9.3. Strategies for Patient Retention

9.3.1. Possible Causes for Abandonment of a Clinical Trial
9.3.2. Strategies and Solutions to the Possible Causes of Abandonment
9.3.3. Long-Term Monitoring of Patients Leaving the Study Prematurely

9.4. Loss of Patient Follow-Up

9.4.1. Definition of Loss of Monitoring
9.4.2. Causes of Loss of Monitoring
9.4.3. Resumption of Monitoring

    9.4.3.1. Re-Inclusion into the Protocol

9.5. Adherence to Pharmacological Treatment under Study

9.5.1. Calculation of Adherence to Pharmacological Treatment
9.5.2. Risk Factors for Therapeutic Non-Compliance
9.5.3. Strategies to Strengthen Adherence to Treatment
9.5.4. Treatment Dropout
9.5.5. Study Drug Interactions

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

9.6.1. Study Medication

9.6.1.1. Different Drug Presentations
9.6.1.2. Procedure and Preparation of Study Medication

9.6.2. Drug-Related Adverse Reactions
9.6.3. Non-Drug Related Adverse Reactions
9.6.4. Adverse Reaction Treatment

9.7. Monitoring of Patient Attendance at Study Visits

9.7.1. Visit Calculator
9.7.2. Study Visits Control
9.7.3. Tools for Compliance and Visitor Control

9.8. Difficulties in Patient Monitoring Within a Clinical Trial

9.8.1. Problems Related to Adverse Patient Events
9.8.2. Problems Related to the Patients Work Situation
9.8.3. Problems Related to the Patients Residence
9.8.4. Problems Related to the Patients Legal Status
9.8.5. Solutions and their Treatments

9.9. Monitoring of Patients in Treatment with Psychopharmaceuticals
9.10. Monitoring of Patients During Hospitalization

Module 10. Biostatistics

10.1. Study Design

10.1.1. Research Question
10.1.2. Population to Analyze
10.1.3. Classification

10.1.3.1. Comparison between Groups
10.1.3.2. Maintenance of the Described Conditions
10.1.3.3. Assignment to Treatment Group
10.1.3.4. Degree of Masking
10.1.3.5. Modality of Intervention
10.1.3.6. Centers Involved

10.2. Types of Randomized Clinical Trials Validity and Biases

10.2.1. Types of Clinical Trials

10.2.1.1. Superiority Study
10.2.1.2 Equivalence or Bioequivalence Study
10.2.1.3 Non-Inferiority Study

10.2.2. Analysis and Validity of Results

10.2.2.1. Internal Validity
10.2.2.2. External Validity

10.2.3. Biases

10.2.3.1. Selection
10.2.3.2. Measurement
10.2.3.3. Confusion

10.3. Sample Size Protocol Deviations

10.3.1. Parameters Used
10.3.2. Protocol Justification
10.3.3. Protocol Deviations

10.4.  Methodology

10.4.1. Missing Data Handling
10.4.2. Statistical Methods

10.4.2.1. Description of Data
10.4.2.2. Survival
10.4.2.3. Logistic Regression
10.4.2.4. Mixed Models
10.4.2.5. Sensitivity Analysis
10.4.2.6. Multiplicity Analysis

10.5. When Does the Statistician Become Part of the Project

10.5.1. Statistician Role
10.5.2. Points of the Protocol to be Reviewed and Described by the Statistician

10.5.2.1. Study Design
10.5.2.2. The Primary and Secondary Objectives of the Study
10.5.2.3. Sample Size Calculation
10.5.2.4. Variables
10.5.2.5. Statistical Justification
10.5.2.6. Material and Methods used to Study the Objectives of the Study

10.6. CRD Design

10.6.1. Information Gathering Variables Dictionary
10.6.2. Variables and Data Entry
10.6.3. Database Security, Testing and Debugging

10.7. Statistical Analysis Plan

10.7.1. What is a Statistical Analysis Plan?
10.7.2. When to Perform the Statistical Analysis Plan
10.7.3. Statistical Analysis Plan Parts

10.8. Intermediate Analysis

10.8.1. Reasons for an Early Termination of a Clinical Trial
10.8.2. Implications of Early Termination of a Clinical Trial
10.8.3. Statistical Designs

10.9. Final Analysis

10.9.1. Final Report Criteria
10.9.2. Plan Deviations
10.9.3. Guidelines for the Elaboration of the Final Report of a Clinical Trial

10.10. Statistical Review of a Protocol

10.10.1. Checklist
10.10.2. Frequent Errors in the Review of a Pro

Thanks to this program you will be up to date with the most effective methods used in Biostatistics”