The Coordination of Clinical Trials is essential to maintain control of the research and to verify that no errors occur during the process. Specialise with us and expand your knowledge in this field"

This Postgraduate certificate in Coordination of Clinical Trials has been designed by TECH with the objective of providing education about the research process to professionals in this field, so that they are able to coordinate Clinical Trials with total safety and professionalism, and thereby ensuring that all the requirements and guarantees of success are met.

The Postgraduate certificate offers a complete program on the Coordination of Clinical Trials, with special emphasis on the investigator's file, where all the documentation related to the research team (Curriculum Vitae and other relevant documents that evidence the qualification of the investigators), 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 are recorded, so their custody must be properly carried out.

In this way, the person in charge of coordination is responsible for the safekeeping of all information related to the study that may be needed in the future. Thus, pharmacists who wish to develop their work in this field will find all the necessary information in a single course, developed by a team of experts in this field.

This program is offered in a fully online format, so that the student will be the one who decides where to study and at what time to do it, so that the completion of this Postgraduate certificate will not prevent them from continuing with the rest of their daily obligations, both professionally and personally.

Expand your knowledge through this Postgraduate certificate that will allow you to specialize until you achieve excellence in this field"

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

• The development of case studies presented by experts in Clinical Coordination of 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 development
• New developments in Clinical Coordination of Trials
• Practical exercises where self-assessment can be used to improve learning
• Special emphasis on innovative methodologies in Clinical Coordination of 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 in the selection of a refresher program for two reasons: in addition to updating your knowledge in Coordination of Clinical Trials, you will obtain a degree from TECH Global University"

Its teaching staff includes professionals from the field of Health, who bring to this program the experience of their work, as well as renowned specialists from leading societies and prestigious universities.

Its 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 an immersive education 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 professional will be assisted by an innovative interactive video system developed by renowned and experienced experts in the field of Clinical Trial Coordination.

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

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

The structure of the contents has been designed by the best professionals in research and health, with an extensive background and recognized prestige in the profession, backed by the volume of cases reviewed, studied and diagnosed, and with extensive mastery of new technologies.  

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

Module 1. Coordination of Clinical Trials (I)

1.1. The Researcher's File - General Aspects

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

1.1.2.1. Original Copies
1.1.2.2. Amendments

1.1.3. Ethical Committees

1.1.3.1. Approvals
1.1.3.2. Amendments

1.1.4. Regulatory Authorities

1.1.4.1. Approvals
1.1.4.2. Modifications
1.1.4.3. Monitoring and Final Reports

1.1.5. Civil Liability Insurance

1.2. Documentation Associated with the 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 Physicians
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

2.1.2.1. Compliance with Good Clinical Practices and Current 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. Calibration
2.4.5.2. Calibration Equipment
2.4.5.3. Valid Certifications
2.4.5.4. Expiration

2.4.6. OtherTraining

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. Visit Preparation

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. Equipment and Materials Necessary

2.7.1.1. Centrifuge
2.7.1.2. Incubator
2.7.1.3. Refrigerators

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. Responsibilities Researcher vs. Research Team

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 Biologicals

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

This will provide key Information to advance your career"