Description

Join our team of students and specialize in clinical trials, an area of research that is constantly growing"

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This postgraduate diploma 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. The investigator's file should contain all the documentation relating to the research team (curriculum vitae and other relevant documents showing the qualifications 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, and should therefore be kept in an appropriate manner.

To this end, this training will discuss the importance of the researcher's file, the documents it should contain, how they should be filed, how they should be completed and how long they should be kept. 

On the other hand, in recent years the figure of clinical trial 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. In this sense, this postgraduate diploma also analyzes the figure of the clinical trial coordinators, as well as their main responsibilities, the vital importance of the trial process and everything that surrounds it.

Finally, the program focuses on the follow-up of patients in the context of a clinical trial, both in Specialized Care and in hospitalization. For this purpose, the different visits defined in the protocol are established, as well as the most frequently used materials (questionnaires, treatment adherence books, symptom cards, electronic devices, etc.).

It is also important for the healthcare professional to be aware of the complications that can arise in patients who participate in these types of studies in order to deal with them, as well as to learn how to develop strategies to prevent participants from dropping out of these trials. 

The goal of healthcare is to achieve a cure for diseases and a better quality of life for patients. Investing in research is important, but so is having specialized professionals"

This postgraduate diploma in Clinical Trials Coordination 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 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 development
  • New developments in Clinical Trials Coordination
  • Practical exercises where self-assessment can be used to improve learning
  • Special emphasis on innovative methodologies in Clinical Trials Coordination
  • 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 for two reasons: in addition to updating your knowledge in Clinical Trials Coordination, you will obtain a qualification endorsed by TECH Technological University"

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 health 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 Trials Coordination.

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

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

Objectives

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

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Thanks to this postgraduate diploma you will be able to specialize in Clinical Trials Coordination and learn about the latest advances in the field”

General Objectives

  • Train the student in the handling and management of the researcher's archive documentation, in accordance with current regulations, the Good Clinical
  • Practice guidelines (GCP) and the International Conference on Harmonization (ICH)
  • Develop legislative knowledge governing the documentation of the 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
  • Examine the treatment of patients within the context of a clinical trial, both in the Specialized Care and in hospitalization
  • 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

Specific Objectives

Module 1. 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 2. 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
  • 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 3. 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
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An intensive program that will allow you to become a specialist in Clinical Trials Coordination in a short period of time and with the greatest flexibility"

Postgraduate Diploma in Clinical Trials Coordination

The development of products, drugs and/or diagnostic techniques is subject to an arduous scientific research process that consists of several phases. Among these is the clinical trial, one of the most relevant stages for the successful development of a project. By means of the evaluation that is carried out through studies applied to people, the aim is to verify the safety, efficacy and guarantees that these will have with their subsequent application or use. Due to the responsibility involved in the execution of these tests, it is necessary to have a team of professionals who are highly trained in skillfully assisting this field of medicine. At TECH Technological University we designed the Postgraduate Diploma in Clinical Trial Coordination, a program that will allow you to expand your knowledge and skills within this discipline.

Become a trial coordinator in clinical research.

The main objective of this program is to favor the specialization of medical professionals in the field of scientific research, specifically in the area of clinical trials. Thus, with the study plan they will have the opportunity to learn about the different phases that are carried out during the development of a new drug, device or treatment; they will be able to establish the basic structure of a clinical trial and identify the difference between its different classes, and they will analyze the circuit of the manufactured product, from its conception to its introduction in the market after the completion of the project. They will also study the content of a clinical research protocol, learn about the commitment involved in complying with its guidelines and understand the rights and duties of the different participating agents during this stage of project management and development.

Get your program in the largest medical school in the world.

At TECH Technological University we have the most complete and innovative curriculum in the sector. With this program, you will be trained through the study and resolution of real cases in simulated environments along with the best techniques and tools focused on online learning. In this way, you will have at your fingertips a complete, concrete and highly flexible program that adjusts to the needs of our students and makes it compatible with the goals and life projects of people who are immersed in the working world.