Description

Learn the main techniques on Clinical Trials thanks to this complete specialization offered by TECH Technological University" 

##IMAGE##

The importance of research in the pharmaceutical field means that public and private institutions are increasingly allocating more resources to this field and, therefore, more specialists are needed who have the specific knowledge that will allow more advances and, therefore, greater effectiveness in the treatments prescribed for certain diseases.

For the completion of this professional master’s degree, the teaching team, consisting of professionals with years of teaching and research experience, has made a careful selection of the units, designed for experienced professionals working in the field. In this way, this program specializes the health professional in the field of Clinical Trials, being able to access the field of the pharmaceutical industry in the management and monitoring of clinical studies. 

The program brings together the most advanced web 2.0 communication tools, which support working methods that encourage interaction among students, the exchange of information and constant and active participation, in addition to offering a theoretical and practical specialization taught by professionals with extensive experience.   

Thanks to this professional master’s degree, students will have the necessary tools and skills to successfully develop their professional activity in the wide environment of Clinical Trials, work on key competencies such as knowledge of the reality and language of healthcare, develop responsibility in the monitoring and supervision of their activities, as well as communication skills in teamwork. 

As it is an online program, the student is not constrained by fixed schedules or the need to move to another physical location, but rather, they can access the contents at any time of the day, allowing them to balance their professional or personal life with their academic life as they please.

Expand your knowledge through this professional master’s degree that will allow you to specialize until you achieve excellence in this field" 

This professional master’s degree in Management and Monitoring of Clinical Trials 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 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 Trials
  • 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 professional master’s degree is the best investment you can make in selecting a refresher program to update your knowledge in the Management and Monitoring of Clinical Trails”

The teaching staff includes professionals from the engineering sector, who bring their experience to this specialization 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 programmed to study 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 management and monitoring.  

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

##IMAGE##

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

Objectives

The program in Clinical Trials Management and Monitoring is aimed at facilitating the performance of the research professional with the latest advances and most innovative treatments in the sector.   

##IMAGE##

Thanks to this professional master’s degree, you will be able to specialize in Management and Monitoring of Clinical Trials 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
  • Justify the difference between different types of clinical trials
  • Compile the essential documents and procedures within a clinical trial
  • Develop 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
  • Compile the rights and duties of the different parties involved in clinical trials
  • Substantiate the concept of monitoring
  • Analyze the content of a clinical research protocol and recognize the commitment that a 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 adapted to the real needs of companies in the pharmaceutical sector
  • Present the wide range of tasks involved in conducting a CT and what is involved at each stage of the clinical trial
  • Explain the practical aspects of conducting a CT and the role of the monitor
  • Develop legislative knowledge governing the documentation of the clinical trial investigator’s file
  • 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
  • Develop specialized knowledge about the variety of tasks they have to perform during the development of the study
  • Establish tools and strategies to approach the different problems that arise during the clinical trial, in order to obtain satisfactory results in patient monitoring
  • Develop knowledge that provides a basis or opportunity to be original in the development and/or application of ideas, often in a research context
  • Apply the acquired knowledge and resolution 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
  • Specify strategies for the dissemination of research results
  • Present 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
  • Specify strategies for developing a safety surveillance plan for marketed drugs
  • Substantiate the necessary requirements for the initiation of research with drugs in humans
  • Establish the elements of a clinical trial research protocol
  • Substantiate the difference between inferiority and non-inferiority clinical Trials
  • Compile the essential documents and procedures within a clinical trial
  • Specify the utility and learn the use of data collection notebooks (DCNs)
  • Disclose 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 through the vision and 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 your responsibility in the selection of the center and in the initiation of the study
  • Justify the importance of the monitor in ensuring, during the trial, the correct compliance with the procedures and activities established by the protocol and the Good Clinical Practice Guidelines
  • Generate 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
  • Prepare 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
  • Justify 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 of 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 specify how to keep it up to date
  • Establish the data collection process to assess safety in a clinical trial. Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Reproduce the management of a monitoring visit
  • Analyze the most common protocol deviations
  • Establish the important documents for a Clinical Trial
  • Submit a Clinical Trial monitor’s guideline (Monitoring plan)
  • 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)

  • Substantiate 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 their inclusion in a clinical trial, managing the CV, good clinical practices, suitability of the facilities etc
  • Reproduce 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 under 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
  • Compile the different types of pharmacological treatments that can be used in a clinical trial (placebo, biological) and their management

Module 8. Follow-up of Patients in Clinical Trials

  • Specify the daily practices of patient care in Specialized Care, establishing the management of procedures, protocols and databases of clinical Trials
  • 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
  • Compile 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 presentations 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 the advanced mathematical model, which represents the 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 the 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
##IMAGE##

A unique specialization course that will enable you to acquire superior education for development in this field”

Professional Master's Degree in Clinical Trial Management and Monitoring.

The management and monitoring of clinical trials is the process of planning, execution, control and supervision of clinical trials, which are research studies conducted in humans to evaluate the safety and efficacy of new therapeutic interventions. It involves oversight of all aspects of the clinical trial, from design to implementation and presentation of results. Clinical trial management and monitoring is performed to ensure that trials are conducted in an ethical, safe and effective manner.

Clinical trial management involves setting up an interdisciplinary team that can design a study plan that meets ethical and regulatory requirements and define the inclusion and exclusion criteria for patient participants.

Clinical trial monitoring is a process of continuous supervision that is carried out throughout the development of the trial to ensure the quality and validity of the data collected. At this stage, periodic visits are made to the research centers participating in the study to ensure that trial participants receive appropriate treatment and meet the criteria established for inclusion in the trial.

In addition, monitoring also focuses on the quality of data recording and the accuracy and reliability of the results, making it a fundamental part of the clinical research process.

Clinical trial management and monitoring is an important process that ensures the safety and efficacy of the medical treatments being investigated. It is a task that requires great responsibility and technical knowledge and is performed in collaboration with a team of health and medical science professionals. It is essential for the identification of new safe and effective treatments for diseases and medical conditions. It is important to ensure that trials are conducted with the highest standards of ethics and safety, and that the results are accurate and reliable for patients and the public.