University certificate
The world's largest faculty of medicine”
Description
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"
The postgraduate certificate 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.
The monitoring of the clinical trial is one of the fundamental sections of this program, since it defines the figure of the sponsor, an essential element for the design and conduct of the research.
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 Organization) 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.
Expand your knowledge through this postgraduate certificate in Clinical Trials Monitoring that will allow you to specialize until you achieve excellence in this field”
This postgraduate certificate in Clinical Trials Monitoring contains the most complete and up-to-date educational 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
- 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 postgraduate certificate is the best investment you can make when selecting a refresher program for two reasons: in addition to updating your knowledge in Clinical Trials Monitoring, you will obtain a qualification endorsed by the world's largest digital university, TECH"
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 program with us. You will find the best teaching material with virtual lessons"
This 100% online postgraduate certificate will allow you to balance your studies with your professional work while increasing your knowledge in this field"
Objectives
The postgraduate certificate in Clinical Trials Monitoring is aimed at facilitating the performance of the research professional with the latest advances and most innovative treatments in the sector.
Thanks to this postgraduate certificate you will be able to specialize in Clinical Trials 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, its function and its relationship with the investigational 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
- Explain the practical aspects of conducting a CT and the role of the monitor of a clinical trial
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, 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
- 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
A unique, key, and decisive training experience to boost your professional development”
Postgraduate Certificate in Clinical Trial Monitoring
Clinical trials have become an essential factor in the treatment of different diseases; over the years, experimental evaluations have been carried out on products and substances as well as on drugs and diagnostic techniques; thanks to this, doctors use a variety of previously experimented and tested treatments to be used on patients. With the progress of technology, advances also arise in this sector, so it is necessary for professionals dedicated to this field to update their knowledge in order to keep abreast of new developments. At TECH we have designed a Postgraduate Certificate in Clinical Trial Monitoring which, in addition to delve into the most important aspects of medical research, will delve into the handling and management of research file documents according to the current regulations of GCP and ICH. Likewise, the basis will be established to define the main components of this procedure and thus, to know the variety of tasks that must be performed during the development of any observational study.
Specialize in monitoring clinical trials
At TECH we provide you with the most updated and complete scientific program in the market. The content and methodology of this curriculum has been designed by a team of professionals dedicated to the research and health sector; this will facilitate the development of your course with the best theoretical and practical techniques. During 300 hours of specialization you will be able to acquire the necessary skills to supervise these processes; this includes team leadership to carry out the functions of the research personnel, the legislative application in archival documents and the management of data collection to evaluate the safety in a clinical trial (AEs and SAEs). By developing this program, you will not only be able to supervise clinical studies, but you will also be able to establish strategies to correctly address the management of different problems that arise during the course of the trials; all this without neglecting the correct compliance of the procedures and activities marked by the protocol and the Good Clinical Practice Standards. Likewise, you will specialize in the management of the monitoring plan and SOPs for the follow-up of each investigation; due to this, you will be able to achieve a percentage of success and effectiveness in the executed projects.