"The goal of health care is to achieve cures for diseases and to provide patients with a better quality of life. Investing in research is important, but so is having specialized professionals" 

The postgraduate diploma in Clinical Trials Monitoring provides students with comprehensive training in the field of clinical research, a key element in the discovery of new drugs to improve the quality of life of patients. A key role in this process is played by the trial monitor, who is responsible for ensuring that the results obtained are reliable.  

In this case, the main functions of the sponsor are analyzed, including the design of the protocol on the basis of which the entire clinical trial is developed, and the promoter's responsibility for the "verification of the adequate and effective monitoring of the clinical trial" is evaluated, in order to establish the close relationship between the sponsor and the monitor. As such, it specifies the profile of the monitor and the skills and abilities to ensure the proper functioning of the study within the research center, complying with Good Clinical Practice standards and protocol requirements.  

On the other hand, the final part of the clinical trial and the SOPs (Standard Operating Procedures) that the CROs (Clinical Research Organizations) propose to the monitors will also be shown.  

In short, a global vision of the monitoring process is presented, so that the healthcare professional will be able to acquire specialized knowledge that will serve as a guide for carrying out this work in a specialized center. 

This postgraduate diploma in Clinical Trials Monitoring will allow you to specialize until you achieve excellence in your profession" 

This postgraduate diploma in Clinical Trials Monitoring contains the most complete and up-to-date scientific program on the market. The most important features include: 

• The development of practical case studies presented by experts in Clinical Trials Monitoring
• 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 Trials Monitoring
• Practical exercises where self-assessment can be used to improve learning
• Special emphasis on innovative methodologies in Clinical Trials Monitoring
• 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 diploma is the best investment you can make when selecting a refresher program to expand your existing knowledge of Clinical Trials Monitoring”

The teaching staff includes professionals from the Health sector, who bring their experience to this training 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 training 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 professor will be assisted by an innovative interactive video system developed by renowned and experienced experts in the field of Monitoring of Clinical Trials. 

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

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

The postgraduate diploma in Clinical Trials Monitoring is aimed at facilitating the performance of the research professional with the latest advances in the sector.  

Thanks to this postgraduate diploma you will be able to specialize in Clinical Trials 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
• 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
• 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

Specific Objectives

Module 1. Clinical Trials (I)

• 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. Monitoring of Clinical Trials (I)

• 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  

Module 3. Monitoring of Clinical Trials (II) 

• Develop the basic principles and ethical norms that regulate biomedical research
• Substantiate the justification of bioethics in the field of research
• Establish the application of ethical principles in the selection of participants
• Specify the principles of the benefit-risk balance in research with drugs and medical devices
• Define informed consent and patient information sheet
• Analyze the guarantees of patient safety in clinical trials
• Establish Good Clinical Practice Standards and their correct application
• Analyze the current European legislation on clinical trials
• Establish procedures for the authorization of drugs and medical devices
• Present the role and structure of clinical research ethics committees

An intensive program that will allow you to become a specialist in Clinical Trials Monitoring in a short period of time and with the greatest flexibility"