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

In recent years, the figure of Clinical Trials 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. 

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. And, for this, TECH wants to offer you this very complete program developed by a team specialized in everything related to Clinical Trials. 

In addition, emphasis is placed on the investigator's file, where all the documentation related to the research team (curriculum vitae and other relevant documents evidencing the qualification 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 are recorded, so their custody must be carried out in an appropriate manner.

This program is delivered completely online, so it will be the students themselves who decide from 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 professional and personal. 

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

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

• The development of 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 practice
• New developments in Clinical Coordination of Trials
• Practical exercises where the self-assessment process can be carried out 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 work
• 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 Trial Coordination, you will obtain a certificate from TECH"

The teaching staff includes professionals from the Health sector, who bring their experience to this educational 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 education programmed to learn in real situations. 

The design of this program focuses on problem-based learning, by means of which the healthcare professional must try to solve the different professional practice situations that arise throughout the academic 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 Trials.

Do not hesitate to take this educational program 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 expanding 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 course contains the most complete and up-to-date 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 Education Certificates
1.2.4. Signed Statement of the Investigator, Financial Disclosure
1.2.4. 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. Researcher's Manual
1.7.2. Technical Data Sheets of the Drugs Under Study (If Marketed)
1.7.3. Instructions for the Control of Specific Parameters (example)
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

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. Documentation Required to Initiate Clinical Trial

2.3.1. Curriculum of the Research Team

2.3.1.1. Basic Notions of a Research Curriculum
2.3.1.2. Good Clinical Practice Example

2.3.2. Good Clinical Practice

2.3.2.1. Origin of Good Clinical Practices
2.3.2.2. How to Get Certified?
2.3.2.3. Expiration

2.3.3. Suitability of the Research Team

2.3.3.1. Who Signs the Document?
2.3.3.2. Presentation to Ethics Committee

2.3.4. Suitability of Facilities

2.3.4.1. Who Signs the Document?
2.3.4.2. Ethical Committee Presentation

2.3.5. Calibration Certificates

2.3.5.1. Calibration
2.3.5.2. Calibration Equipment
2.3.5.3. Valid Certifications
2.3.5.4. Expiration

2.3.6. Other Training

2.3.6.1. Necessary Certifications According Protocol

2.4. Main Functions Trial Coordinator

2.4.1. Documentation Preparation

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

2.4.2. Investigator Meeting

2.4.2.1. Importance
2.4.2.2. Attendees

2.4.3. Initiation Visit

2.4.3.1. Duties of the Coordinator
2.4.3.2. Functions of the Principal Investigator and Subinvestigators
2.4.3.3. Monitor

2.4.4. Monitoring Visit

2.4.4.1. Preparation After a Monitoring Visit
2.4.4.2. Functions During the Monitoring Visit

2.4.5. End-Of-Study Visit

2.4.5.1. Storage of the Researchers File

2.5. Relationship with the Patient

2.5.1. Preparation of Visits

2.5.1.1. Consents and Amendments
2.5.1.2. Visit Window
2.5.1.3. Identify the Responsibilities of the Investigation Team during the Visit
2.5.1.4. Visit Calculator
2.5.1.5. Preparation of Documentation to be Used During the Visit

2.5.2. Complementary Tests

2.5.2.1. Analysis
2.5.2.2. Chest X-Ray
2.5.2.3. Electrocardiogram

2.5.3. Calendar of Visits

2.5.3.1. Example

2.6. Samples

2.6.1. Equipment and Materials Necessary

2.6.1.1. Centrifuge
2.6.1.2. Incubator
2.6.1.3. Refrigerators

2.6.2. Processing of Samples

2.6.2.1. General Procedure
2.6.2.2. Example

2.6.3. Laboratory Kits

2.6.3.1. What Are They?
2.6.3.2. Expiration

2.6.4. Shipment of Samples

2.6.4.1. Sample Storage
2.6.4.2. Ambient Temperature Shipment
2.6.4.3. Shipping Frozen Samples

2.7. Data Collection Notebooks

2.7.1. What Is It?

2.7.1.1. Types of Notebooks
2.7.1.2. Paper Notebook
2.7.1.3. Electronic Notebook
2.7.1.4. Specific Notebooks According to Protocol

2.7.2. How To Complete It?

2.7.2.1. Example

2.7.3. Query

2.7.3.1. What Is a Query?
2.7.3.2. Resolution Time
2.7.3.3. Who Can Open a Query?

2.8. Randomization Systems

2.8.1. What Is It?
2.8.2. Types of IWRS:

2.8.2.1. Telephonics
2.8.2.2. Electronics

2.8.3. Responsibilities Researcher Vs. Research Team

2.8.3.1. Screening
2.8.3.2. Randomization
2.8.3.3. Scheduled Visits
2.8.3.4. Unscheduled Visits
2.8.3.5. Blinding Opening

2.8.4. Medication

2.8.4.1. Who Receives the Medication?
2.8.4.2. Drug Traceability

2.8.5. Return of Medication

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

2.9. Biological Treatments

2.9.1. Coordination of Clinical Trials with Biologics

2.9.1.1. Biological Treatments
2.9.1.2. Types of Treatment

2.9.2. Types of Studies

2.9.2.1. Biological Criteria Placebo
2.9.2.2. Biological Criteria Biological

2.9.3. Biological Management

2.9.3.1. Administration. 2.9.3.2. Traceability

2.9.4. Rheumatic Diseases

2.9.4.1. Rheumatoid Arthritis
2.9.4.2. Psoriatic Arthritis
2.9.4.3. Lupus
2.9.4.4. Scleroderma

This will be a key specialization to advance your career"