Proper coordination of investigations is essential to achieve effective and quality results. Don't miss the opportunity to learn with us"

The figure of the coordinator is essential in any type of research to ensure that all the work is carried out properly and in accordance with current regulations. In addition, they are responsible for recording all the information related to the research, taking into account that the investigator's file should contain all the documentation related to the research team (curriculum vitae and other relevant documents that evidence the qualification of the researchers) 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 adequate manner. 

In this sense, this Postgraduate diploma analyzes the importance of the investigator's file, as well as the figure of the Clinical Trial Coordinator and their main responsibilities, the vital importance of the trial process and everything that surrounds it. 

This program has a syllabus of the highest academic level that has been designed by a team of specialists with years of professional and teaching experience. A multidisciplinary program that aims to broaden the knowledge of nurses. And all of this with a 100% online format thanks to which you will be able to self-manage your study time, deciding where and when to study. No time limits or need to move to a physical space, so you can balance it perfectly with the rest of your daily obligations.

This Postgraduate diploma in Clinical Trials Coordination for Nursing will enable you to achieve excellence in your profession"

This Postgraduate diploma in Clinical Trials Coordination for Nursing contains the most complete and up-to-date scientific program on the market. The most important features 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 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 diploma is the best investment you can make in the selection of a refresher program for two reasons: in addition to updating your knowledge in Clinical Trial Coordination, you will obtain a Postgraduate diploma from TECH"

The teaching staff includes professionals from the Health field, 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. 

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.

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

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

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 diploma 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 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 (example Ta)
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. 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 Sub-Investigators
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. 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. 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 for Nursing 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

Module 3. Follow-up of Patients in Clinical Trials 

3.1. Patient Care in Outpatient Clinics

3.1.1. Visits in the Protocol

3.1.1.1. Visits and Procedures
3.1.1.2. Window of Realization of the Different Visits
3.1.1.3. Database Considerations

3.2. Materials Used in the Different Study Visits

3.2.1. Questionnaires
3.2.2. Drug Adherence Cards
3.2.3. Symptom Cards
3.2.4. Study Card
3.2.5. Electronic Devices
3.2.6. Suicide Risk Scales
3.2.7. Material for the Displacement of Patients
3.2.8. Others

3.3. Strategies for Patient Retention

3.3.1. Possible Causes for Abandonment of a Clinical Trial
3.3.2. Strategies and Solutions to the Possible Causes of Abandonment
3.3.3. Long-Term Monitoring of Patients Leaving the Study Prematurely

3.4. Loss of Patient Follow-Up:

3.4.1. Definition of Loss of Monitoring
3.4.2. Causes of Loss of Monitoring
3.4.3. Resumption of Monitoring

3.4.3.1. Re-Inclusion Back into the Protocol

3.5. Adherence to Pharmacological Treatment under Study

3.5.1. Calculation of Adherence to Pharmacological Treatment
3.5.2. Risk Factors for Therapeutic Non-Compliance
3.5.3. Strategies to Strengthen Adherence to Treatment
3.5.4. Treatment Dropout
3.5.5. Study Drug Interactions

3.6. Monitoring of Adverse Reactions, and Symptom Management in the Study Medication Administration:

3.6.1. Study Medication

3.6.1.1. Different Drug Presentations
3.6.1.2. Procedure and Preparation of Study Medication

3.6.2. Drug-Related Adverse Reactions
3.6.3. Non-Drug Related Adverse Reactions
3.6.4. Adverse Reaction Treatment

3.7. Monitoring of Patient Attendance at Study Visits

3.7.1. Visit Calculator
3.7.2. Study Visits Control
3.7.3. Tools for Compliance and Visitor Control

3.8. Difficulties in Patient Monitoring Within a Clinical Trial:

3.8.1. Problems Related to Adverse Patient Events
3.8.2. Problems Related to the Patients Work Situation
3.8.3. Problems Related to the Patients Residence
3.8.4. Problems Related to the Patients Legal Status
3.8.5. Solutions and their Treatments

3.9. Monitoring of Patients in Treatment with Psychopharmaceuticals
3.10. Monitoring of Patients During Hospitalization