A complete program that will help you keep up to date with the latest techniques 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 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 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 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 Clinical Trials Management and Monitoring, you will obtain a professional master’s degree from TECH Technological 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 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 program in Clinical Trials Management and Monitoring is aimed at facilitating the performance of research professionals with the latest advances and most innovative procedures in the sector.

Thanks to this professional master’s degree you will be able to specialize in Clinical Trials Management and Monitoring and learn about the latest advances in the field"

General objectives

• Establish the phases involved in the development of a new drug
• Analyze the steps prior to the development of a clinical trial (preclinical research)
• Examine how a drug is introduced into the market after the clinical trial has been conducted
• Establish the basic structure of a clinical trial
• Be aware of the differences between different types of clinical trials
• List the essential documents and procedures within a clinical trial
• Study the clinical trial drug circuit from the point of view of the Pharmacy Service
• Analyze universal ethical principles
• Define the current legislation on research with drugs and medical devices in general and that which regulates clinical trials in particular
• List the rights and responsibilities of the different parties involved in clinical trials
• Explore the concept of monitoring
• Analyze the content of a clinical research protocol and recognize the commitment that good compliance with it entails
• Master the skills necessary for project development and management
• Define the monitoring process of a clinical trial, having the necessary documentation, tools and guidance for this role, taking into account the main problems that may be encountered
• Present the latest scientific advances in clinical trial monitoring tasks, with knowledge tailored to the real needs of companies in the pharmaceutical sector
• Present the wide range of tasks involved in conducting a clinical trial and what is involved at each stage
• Examine the practical aspects of conducting a clinical trial and the role of the monitor
• Analyze the importance of the role of the trial coordinator in clinical research
• Specify the main functions of the research team and their involvement with the patient
• Establish the main components of a clinical trial and observational study
• Build specialist knowledge about the variety of tasks must be performed during the development of the study
• Establish tools and strategies to address the different problems that arise during the clinical trial, in order to obtain satisfactory results from patient monitoring
• Build a base of knowledge that allows for originality in the development and/or application of ideas, often in a research context
• Apply acquired knowledge and problem-solving skills in the development of protocols
• Structure statistical methods and techniques
• Communicate and transmit statistical results through the preparation of different types of reports, using terminology specific to the fields of application
• Compile, identify and select sources of public biomedical information, from international agencies and scientific organizations, on the study and dynamics of populations
• Analyze the scientific method and work on skills in the management of information sources, bibliography, protocol elaboration and other aspects considered necessary for the design, execution and critical assessment
• Demonstrate logical thinking and structured reasoning in determining the appropriate statistical technique

Specific objectives

Module 1. Drug Research and Development

• Explain the pharmacokinetic processes that a drug undergoes in the organism
• Identify the legislation that regulates each of the steps in the development and authorization of a drug
• Define the specific regulation of some drugs (biosimilars, advanced therapies)
• Define the use in special situations and their types
• Examine the process of financing a drug
• Outline strategies for the dissemination of research results
• Demonstrate how to read scientific information critically 
• Compile sources of information on drugs and their types

Module 2. Clinical Trials (I)

• Establish the types of clinical trials and standards of good clinical practice
• Specify the processes of authorization and distinction of drugs and medical devices in research
• Analyze the evolutionary process of drug research development
• Finalize strategies for developing a safety surveillance plan for saleable drugs
• Substantiate the requirements for the initiation of drug research with humans
• Establish the elements of a clinical trial research protocol
• Explore the difference between inferiority and non-inferiority clinical trials
• List the essential documents and procedures within a clinical trial
• Study the function and use of data collection notebooks (DCNs)
• Study the types of fraud committed in clinical trials research

Module 3. Clinical Trials (II)

• Specify the different activities related to sample management (reception, dispensing, custody, etc.) in which the Pharmacy team is involved
• Establish the procedures and techniques involved in the safe handling of samples during their preparation
• Analyze the development of a clinical trial from the point of view and through the participation of the hospital pharmacist
• Detail informed consent
• Know the physiological differences between children and adults

Module 4. Monitoring of Clinical Trials (I)

• Specify both the professional profile of the clinical trial monitor and the skills that must be developed to carry out the monitoring process of a clinical trial
• Establish their responsibility in the selection of the center and in the initiation of the study
• Justify the importance of the monitor in ensuring the correct compliance with the procedures and activities established by the protocol and the Good Clinical Practice Guidelines during the trial
• Build knowledge on the practical aspects of visits prior to the start of the clinical trial
• Present the basis for the essential documentation for the implementation of the clinical trial at the center
• Train the student in the correct handling of a pre-selection visit and initiation in the research center
• Assess the involvement of the Hospital Pharmacy Service in the management, control and traceability of the medication in the study
• Be aware of the importance of maintaining good communication between team members involved in the development of a clinical trial

Module 5. Monitoring of Clinical Trials (II)

• Establish the basic points for a monitoring and closing visit
• Develop the Monitoring Plan and Standard Operating Procedures (SOPs) at each stage of the clinical trial
• Present a data collection notebook and learn how to keep it up to date
• Establish the data collection process to assess safety in a clinical trial Adverse Event and Serious Adverse Event
• Detail the management of a monitoring visit
• Analyze the most common protocol deviations
• Establish the important documents for a clinical trial
• Submit a Monitoring Plan for a clinical trial monitor
• Present the data collection notebooks
• Develop important theoretical knowledge about closeout visits
• Establish the documentation to be prepared for closeout visits
• Specify the points to be reviewed in the closeout visits

Module 6. Coordination of Clinical Trials (I)

• Specify the mandatory documents and forms that must be included in the researcher’s file
• Establish how to best manage the archive at the beginning, during and at the end of the study: storing, updating and ordering documentation
• Define the steps to be followed to complete the documents and forms for the researchers file

Module 7. Coordination of Clinical Trials (II)

• Reinforce the necessary skills to be developed in order to perform the work of the trial coordinator
• Define the organization and preparation of both the research team and the center for inclusion in a clinical trial, managing CVs, good clinical practices, suitability of the facilities, etc.
• List the tasks to be performed in both a clinical trial and an observational study
• Analyze a clinical trial protocol through theoretical and practical examples
• Determine the work of a Coordinator in their work center in accordance with a clinical trial protocol (patients, visits, tests)
• Develop the skills necessary for the use of a data collection notebook: data entry, query resolution and sample processing
• List the different types of pharmacological treatments that can be used in a clinical trial (placebo, biological) and their management

Module 8. Patients Monitoring in Clinical Trials

• Specify the daily practices of patient care in Specialized Care, establishing the management of procedures, protocols and clinical trial databases
• Analyze the materials used during the development of the studies
• Assess the causes of patient dropout within a study and establish strategies for patient retention
• Assess how monitoring loss occurs in patients within a study, examine its causes and explore possibilities for resumption of monitoring
• List the different risk factors that can lead to poor adherence to treatment and apply strategies for improving and monitoring adherence to treatment
• Analyze the different effects of medications in order to manage the signs and symptoms, as well as the adverse reactions that may derive from taking medication
• Establish the different tools to calculate the attendance and monitoring of visits

Module 9. Biostatistics

• Identify and incorporate in an advanced mathematical model representing an experimental situation, those random factors involved in a high-level biosanitary study
• Design, collect and clean a data set for subsequent statistical analysis
• Identify the appropriate method for determining sample size
• Distinguish between different types of studies and choose the most appropriate type of design according to the research objective
• Communicate and transmit statistical results correctly, through the preparation of reports
• Acquire an ethical and social commitment

A unique specialization that will allow you to acquire superior knowledge to develop in this field”