A complete program that will help you keep up to date with the latest techniques in MBA in Clinical Trials Management and Monitoring"

The increased investment into research in the healthcare field in order to improve the patients’ quality of life means that more and more specialized professionals are needed in this field. Hence the importance of expanding academic knowledge in all research areas. The Professional master’s degree in MBA in Clinical Trials Management and Monitoring is a program developed by professionals with extensive professional experience in the field of clinical trials and who are currently working in this area. 

The teaching team has carefully selected a range of the most useful topics for experienced professionals working in healthcare. This program employs the most advanced web 2.0 communication tools, which allow working methods that promote interaction among professionals, information exchange and constant and active participation. 

Specifically, this Professional master’s degree guides the health professional through the Management and Monitoring of Clinical Trials, via a theoretical and practical course provided by professionals with extensive experience. 

Thanks to this Professional master’s degree, the physician will have the necessary tools and the ability to successfully improve their professional practice in the vast world of Clinical Trials, to work on key skills such as knowledge of the day-to-day realities and language of healthcare, to take on responsibility for the monitoring and supervision of clinical trial activities, as well as developing communication skills to promote effective teamwork. 

Expand your knowledge through this Professional master’s degree in MBA in Clinical Trials Management and Monitoring which will enable you to hone your skills until you achieve excellence in this field”

This Professional master’s degree in MBA in Clinical Trials Management and Monitoring contains the most complete and up-to-date scientific program on the market. The most important features include:

• The examination of case studies presented by experts in Clinical Trials
• Graphic, schematic, and practical contents which provide scientific and practical information on the disciplines that are essential for professional practice
• New developments in Clinical Trials
• Practical exercises where a self-assessment process can be undertaken 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 Clinical Trials Management and Monitoring, you will obtain a Professional master’s degree from TECH Global University"

The teaching staff includes medical professionals who contribute their experience to this 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 learning designed for real situations. 

This program is designed around Problem-Based Learning, whereby the professional must try to solve the different professional practice situations that arise throughout the program. For this purpose, the professional will be assisted by a innovative interactive video system developed by renowned and experienced experts in the field of MBA in Clinical Trials Management and Monitoring.

Do not hesitate to take this Professional master’s degree with us. You will find the best teaching material with virtual lessons"

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

The syllabus has been designed by renowned professionals in research and health, with impressive professional careers, backed by a huge volume of cases reviewed, studied and diagnosed, and with excellent command of new technologies. 

This Professional master’s degree in MBA in Clinical Trials Management and Monitoring contains the most complete and up-to-date scientific program on the market" 

Module 1. Drug Research and Development

1.1. Development of New Drugs

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

1.2. Discovery of an Active Substance

1.2.1. Pharmacology
1.2.2. Seeding Trials
1.2.3. Pharmacological Interactions

1.3. Pharmacokinetics

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

1.4. Toxicology

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

1.5. Regulation of Drugs for Human Use

1.5.1. Introduction
1.5.2. Authorization Procedures
1.5.3. How is a Drug Evaluated? Authorization File
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 Clinical Trials (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 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. 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. Checking Out

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. Installations
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. Initial 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/Underdosage

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. Long-Term 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
3.5.2.4. Dose-Limiting Toxicities
3.5.2.5. Interrupting the Treatment

3.5.3. Quality Control and Compliance

3.5.3.1. Authorization of Subjects Protected Health Information
3.5.3.2. Retention of Study Records and Files
3.5.3.3. Data Collection Notebooks
3.5.3.4. Protocol Amendments

3.5.4. 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. Initial 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 and Unexpected Serious Adverse Reactions (SUSARs)
3.6.6.5. Accounting

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

3.7. General Information about Clinical Trials in Children and Adolescents

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

3.8. Clinical Trials in Adolescents

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

3.9. Clinical Trials in Children

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

3.10. Clinical Trials in Neonatal

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

Module 4. Clinical Trial Monitoring (I)

4.1. Promoter I

4.1.1. General Aspects
4.1.2. Promoters 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. Clinical 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 Consider
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. Initial Visit

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

4.10. Hospital Pharmacy Initial Visit

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

Module 5. Clinical Trial Monitoring (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. SAEs
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 and Unexpected Serious Adverse Reactions (SUSARs)

5.1.3.6.1. Concept
5.1.3.6.2. 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. Development
5.4.3.4. Intensity
5.4.3.5. Actions Taken
5.4.3.6. Causality 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 Security 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. Standard Operating Procedures (SOP) for the Initial Visit

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

5.5.5. SOP for 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 Close-Out 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 to Prepare an Audit?
5.6.4. Main 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
5.7.6.5. 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. Organisation
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. Clinical Trial Coordination (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 Training 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 (e.g. Temperature)
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. Clinical Trial Coordination (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 Meetings

7.5.2.1. Importance
7.5.2.2. Attendees

7.5.3. Initial Visit

7.5.3.1. Duties of the Coordinator
7.5.3.2. Roles 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. Visit Calendar

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. Patient Monitoring 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 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. Monitoring of Adverse Reactions and Symptom Management in the Study Medication

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 be Analyzed
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. Blinding Degree
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 to be 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. Statistical 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

9.5. Design of the CRF (Case Report Form)

9.5.1. Data Collection: Dictionary of Variables
9.5.2. Variables and Data Entry
9.5.3. Database Security, Testing and Debugging

9.7. Statistical Analysis Plan

9.7.1. Statistical Analysis Plan
9.7.2. When to Perform a 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

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