The goal of healthcare is to achieve a cure for diseases and a better quality of life for patients. Investing in research is important, but so is having specialized professionals"

This Postgraduate certificate in Clinical Trials Coordination is designed for students to acquire the necessary skills and abilities so that there can be no errors in this part of the process. The investigator's file should contain all the documentation relating to the research team (curriculum vitae and other relevant documents showing the qualifications of the investigators) and the patient (informed consents, recruitment measures, monitoring visits), the study protocol, the investigator's manual, a model of the data collection notebook, and the different laboratory and safety procedures, and should therefore be kept in an appropriate manner. 

To this end, this training will discuss the importance of the researcher's file, the documents it should contain, how they should be filed, how they should be completed and how long they should be kept. 

On the other hand, in recent years the figure of clinical trial coordinator has become a fundamental and essential part of a research unit. There is an increasing demand from developers for a person to organize the research team and to serve as a link between the pharmaceutical industry and the research center itself. In this sense, this program also analyzes the figure of the clinical trial coordinators, as well as their main responsibilities, the vital importance of the trial process and everything that surrounds it.

Expand your knowledge through this Postgraduate certificate in Clinical Trials Coordination that will allow you to specialize until you achieve excellence in this field”

This Postgraduate certificate in Clinical Trials Coordination contains the most complete and up-to-date educational program on the market. The most important features include:

• The development of practical case studies presented by experts in Clinical Trials Coordination
• The graphic, schematic, and practical contents with which they are created, provide scientific and practical information on the disciplines that are essential for professional development
• New developments in Clinical Trials Coordination
• 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 Postgraduate certificate is the best investment you can make when selecting a refresher program for two reasons: In addition to updating your knowledge in Clinical Trials Coordination, you will obtain a qualification endorsed by TECH Global University”

The teaching staff includes professionals from the Health sector, who bring their experience to this training program, as well as renowned specialists from leading societies and prestigious universities. 

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 training 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 professor will be assisted by a innovative interactive video system developed by renowned and experienced experts in the field of Clinical Trials Coordination.

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

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

The structure of the contents has been designed by the best professionals in the field of Clinical Trials Coordination, with extensive experience and recognized prestige in the profession, backed by the volume of cases reviewed, studied and diagnosed, and with extensive knowledge of new technologies applied to the Coordination of Clinical Trials.

This Postgraduate certificate in Clinical Trials Coordination contains the most complete and up-to-date scientific program on the market” 

Module 1. Coordination of Clinical Trials (I)

1.1. The Researcher's File - General Aspects

1.1.1. ¿Qué es el archivo del investigador? ¿Qué tipo de documentación debe contener y por qué? ¿Durante cuánto tiempo debe almacenarse la información?
1.1.2. Contrato

1.1.2.1. Ejemplares originales
1.1.2.2. Enmiendas

1.1.3. Comités Éticos

1.1.3.1. Aprobaciones
1.1.3.2. Enmiendas

1.1.4. Autoridades Reguladoras

1.1.4.1. Aprobaciones
1.1.4.2. Modificaciones
1.1.4.3. Informes de seguimiento y finales

1.1.5. Seguro de Responsabilidad Civil

1.2. Documentation Associated with Research Team

1.2.1. CV
1.2.2. Good Clinical Practice Certificate
1.2.3. Specific Training Certificates
1.2.4. Signed Statement of the Investigator, “Financial Disclosure” 
1.2.5. Task Delegation

1.3. Study Protocol and Monitoring

1.3.1. Protocol Versions, Summary and Pocket Guides
1.3.2. Protocol
1.3.3. Protocol Amendments
1.3.4. Protocol Signature Form

1.4. Patient Related Material

1.4.1. Patient Information Form and Informed Consent Form (Copies and Specimens for Signature) 
1.4.2. Modifications to the Consent (Copies and Specimens for Signature) 
1.4.3. Study Participation Cards
1.4.4. Information for Primary Care Physician
1.4.5. Questionnaires

1.5. Patient Forms, Monitoring Visits

1.5.1. Patient Screening Form
1.5.2. Patient Recruitment and Identification Form
1.5.3. Visit Logs and Reports Form

1.6. Data Collection Notebooks (DCNs)  

1.6.1. Types
1.6.2. Guide or Manual for Data Entry in the DCN
1.6.3. Copy of DCN

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

1.7.1. Investigators Brochure (IB)
1.7.2. Technical Data Sheets of the Drugs Under Study (If Marketed) 
1.7.3. Instructions for the Control of Specific Parameters (e.g. Temperature) 
1.7.4. Instructions for Return of Medication or Medical Devices

1.8. Material Related to Laboratory and Specific Procedures

1.8.1. Central Laboratories and Sample Shipping Documents
1.8.2. Local Laboratory: Qualification Certificates and Ranks
1.8.3. Instructions for Acquiring and/or Processing Medical Images
1.8.4. Sample and Material Shipment

1.9. Security/Safety

1.9.1. Adverse Events and Serious Adverse Events
1.9.2. Notification Instructions
1.9.3. Relevant Security Correspondence

1.10. Others

1.10.1. Contact Information
1.10.2. “Note to File” 
1.10.3. Correspondence with the Promoter
1.10.4. Acknowledgements of Receipt
1.10.5. Newsletter

Module 2. Coordination of Clinical Trials (II) 

2.1. Research Team

2.1.1. Components of a Research Team
    2.1.1.1. Principal Investigator
    2.1.1.2. Sub-Investigator
    2.1.1.3. Coordinator
    2.1.1.4. Rest of the Team

2.1.2. Responsibilities of the Research Team Legislation
    2.1.2.2. Compliance of the Study Protocol
    2.1.2.3. Care and Maintenance of the Research Archive

2.1.3. Task Delegation
    2.1.3.1. Document Details
    2.1.3.2. Example

2.2. Trial Coordinator

2.2.1. Responsibilities

2.2.1.1. Primary Responsibilities
2.2.1.2. Secondary Responsibilities

2.2.2. Capabilities and Competencies

2.2.2.1. Academic Background
2.2.2.2. Skills

2.2.3. Clinical Trials vs. Observational Study

2.2.3.1. Types of Clinical Trials
2.2.3.2. Types of Observational Studies

2.3. Protocol

2.3.1. Primary and Secondary Objectives
   

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

2.3.2.    Inclusion and Exclusion Criteria

2.3.2.1. Inclusion Criteria
2.3.2.2. Exclusion Criteria
2.3.2.3. Example

2.3.3.    Flowchart

2.3.3.1. Document and Explanation

2.3.4. Concomitant Medication and Prohibited Medication

2.3.4.1. Concomitant Drug
2.3.4.2. Forbidden Medication
2.3.4.3. Washout Periods

2.4. Documentation Required to Initiate Clinical Trial

2.4.1. Curriculum of the Research Team

2.4.1.1. Basic Notions of a Research Curriculum
2.4.1.2. Good Clinical Practice Example

2.4.2. Good Clinical Practice

2.4.2.1. Origin of Good Clinical Practices
2.4.2.2. How to Get Certified?
2.4.2.3. Expiration

2.4.3. Suitability of the Research Team

2.4.3.1. Who Signs the Document? 
2.4.3.2. Presentation to Ethics Committee

2.4.4. Suitability of Facilities

2.4.4.1. Who Signs the Document? 
2.4.4.2. Ethical Committee Presentation

2.4.5. Calibration Certificates

2.4.5.1. Calibración
2.4.5.2. Equipos para calibrar
2.4.5.3. Certificaciones válidas
2.4.5.4. Caducidad2.4.5.1. Calibration
2.4.5.2. Calibration Equipment
2.4.5.3. Valid Certifications
2.4.5.4. Expiration

2.4.6. Other Training

2.4.6.1. Necessary Certifications According Protocol

2.5. Main Functions Trial Coordinator

2.5.1. Documentation Preparation

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

2.5.2. Investigator Meeting

2.5.2.1. Importance
2.5.2.2. Attendees

2.5.3. Initiation Visit

2.5.3.1. Duties of the Coordinator
2.5.3.2. Functions of the Principal Investigator and Subinvestigators
2.5.3.3. Promoter
2.5.3.4. Monitor

2.5.4. Monitoring Visit

2.5.4.1. Preparation After a Monitoring Visit
2.5.4.2. Functions During the Monitoring Visit

2.5.5. End-Of-Study Visit

2.5.5.1. Storage of the Researchers File

2.6. Relationship with the Patient

2.6.1. Preparation of Visits

2.6.1.1. Consents and Amendments
2.6.1.2. Visit Window
2.6.1.3. Identify the Responsibilities of the Investigation Team during the Visit
2.6.1.4. Visit Calculator
2.6.1.5. Preparation of Documentation to be Used During the Visit

2.6.2. Complementary Tests

2.6.2.1. Analysis
2.6.2.2. Chest X-Ray
2.6.2.3. Electrocardiogram

2.6.3. Calendar of Visits

2.6.3.1. Example

2.7. Samples

2.7.1. Equipamiento y material necesario

2.7.1.1. Centrifuga
2.7.1.2. Incubadora
2.7.1.3. Neveras

2.7.2. Processing of Samples

2.7.2.1. General Procedure
2.7.2.2. Example

2.7.3.  Laboratory Kits

2.7.3.1. What are they? 
2.7.3.2. Expiration

2.7.4. Shipment of Samples

2.7.4.1. Sample Storage
2.7.4.2. Ambient Temperature Shipment
2.7.4.3. Shipping Frozen Samples 

2.8. Data Collection Notebooks

2.8.1. What Is It?

2.8.1.1. Types of Notebooks
2.8.1.2. Paper Notebook
2.8.1.3. Electronic Notebook
2.8.1.4. Specific Notebooks According to Protocol

2.8.2. How To Complete It? 

2.8.2.1. Example

2.8.3. Query

2.8.3.1. What Is A Query? 
2.8.3.2. Resolution Time
2.8.3.3. Who Can Open a Query? 

2.9.    Randomization Systems

2.9.1. What Is It? 
2.9.2. Types of IWRS:

2.9.2.1. Telephonics
2.9.2.2. Electronics

2.9.3. Researcher Responsibilities vs. Research Team Responsibilities

2.9.3.1. Screening
2.9.3.2. Randomization
2.9.3.3. Scheduled Visits
2.9.3.4. Unscheduled Visits
2.9.3.5. Blinding Opening

2.9.4. Medication

2.9.4.1. Who Receives the Medication? 
2.9.4.2. Drug Traceability

2.9.5. Return of Medication

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

2.10. Biological Treatments

2.10.1. Coordination of Clinical Trials with Biologics

2.10.1.1. Biological Treatments
2.10.1.2. Types of Treatment

2.10.2. Types of Studies

2.10.2.1. Biological Criteria Placebo
2.10.2.2. Biological Criteria Biological Criteria

2.10.3. Biological Management

2.10.3.1. Administration
2.10.3.2. Traceability

2.10.4. Rheumatic Diseases

2.10.4.1. Rheumatoid Arthritis
2.10.4.2. Psoriatic Arthritis
2.10.4.3. Lupus
2.10.4.4. Scleroderma

A unique, key and decisive training experience to boost your professional development"