Description

Having professionals specialized in the field of Clinical Trial Monitoring is essential to achieve positive results"

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The postgraduate certificate in Clinical Trial Monitoring has been designed with the objective of providing education to professionals in this important area of research, since, if this process is not carried out correctly, it will not be possible to determine the validity of the results.  

Thanks to this specialization, the student will know in depth the protocol from which the whole clinical trial is developed, as well as the development of the monitoring, establishing the most common protocol deviations and specifying solutions for specific cases. 

Relevant aspects such as the follow up visit and the closing visit, essential documents and source documents, or how to work, in daily practice, with the use of data collection notebooks, among other aspects, will also be analyzed. 

In short, a global vision of the monitoring process is presented, so that pharmacists will be able to increase their skills and abilities in this field, so that they will be able to participate in this type of research, contributing their full value as professionals. In addition, this postgraduate certificate has the advantage of being developed in a 100% online format, so it will be the students themselves who distribute their study time as they wish, being able to combine it with the rest of their daily obligations. 

Expand your knowledge through this postgraduate certificate that will allow you to specialize until you achieve excellence in this field"

This postgraduate certificate in Clinical Trial Monitoring contains the most complete and up to date educational program on the market. The most important features include: 

  • The development of case studies presented by experts in Clinical Trial 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 Trial 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 certificate 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 Monitoring, you will obtain a degree from the leading online university in Spanish: TECH”  

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 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. To do so, the professional will be assisted by an innovative interactive video system created by renowned and experienced experts in the field of Clinical Trial Monitoring.   

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 certificate will allow you to combine your studies with your professional work while increasing your knowledge in this field” 

Objectives

The postgraduate certificate in Clinical Trial Monitoring 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 certificate you will be able to specialize in Clinical Trial Monitoring and learn about the latest advances in the field" 

General Objectives

  • Establish the different roles that exist in the figure of the clinical trial sponsor, their function and their relationship with the investigator's center
  • 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
  • Substantiate the practical aspects of conducting a CE and the role of the clinical trial monitor

Specific Objectives

  • 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 the correct compliance with the procedures and activities established by the protocol and the standards of good clinical practice during the trial
  • 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
  • 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 
  • Justify the importance of maintaining good communication between team members involved in the development of a clinical trial
  • 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
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Take the opportunity and take the step to get up to speed on the latest developments in Clinical Trial Monitoring" 

Postgraduate Certificate in Clinical Trial Monitoring

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The clinical trial monitoring process is crucial to ensure the safety and efficacy of drugs to be made available to the general public. The role of the clinical trial monitor is fundamental in this process, as he/she is in charge of supervising and ensuring that the established protocols are complied with, and that the data obtained are reliable and accurate. TECH has designed the Postgraduate Certificate in Clinical Trial Monitoring, in which you will be able to address relevant topics such as protocol design, data analysis and deviation management.

A high-level teaching team

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Clinical Trial Monitoring is a demanding task that requires specialized and updated training in the field of clinical research. This Postgraduate Certificate, through a 100% online methodology and the wide experience of professionals in this field, provides an overview of the Monitoring process and provides the necessary skills and abilities to ensure the safety and efficacy of Clinical Trials.