Clinical Trials: From Theory to Practice
This course is designed to provide comprehensive knowledge about the planning, implementation, and evaluation of clinical trials.
Program Description
The "Clinical Trials: From Theory to Practice" training provides an insight into basic concepts and key rules of the Good Clinical Practice Guidelines. Participants will explore international standards of ICH GCP and learn how to apply them. Through case studies, attendees will develop basic knowledge necessary to begin working in this industry.
Program Content
Day 1 (October 26)
Clinical trials are an essential step in the development of drugs and medical devices that will be registered and used. Therefore, it is necessary to become familiar with the basic concepts that will be regularly used, and here are just some of the questions we will address:
- What is the sponsor of a clinical trial, and what is a CRO company?
- What types of clinical trials exist, what stages are there, what is tested, and how long do trials last?
- What is informed consent, how does it look, and what does it contain?
- How does it look in practice, and what are the most important regulatory acts, contracts, and legal prerequisites for starting a trial?
Day 2 (October 27)
Learning through examples from the history of drug and medical device development, there was a need to establish strict and universally accepted guidelines for conducting clinical studies. In simple terms, this is where your journey into the core of clinical studies begins, so we will focus on the following questions:
- What are the ICH GCP guidelines by definition? What led the pharmaceutical industry to develop these guidelines?
- How did the development of these guidelines progress, what do they cover today, and how are they applied in practice?
- How are the 13 principles of the ICH GCP guidelines used as a foundation for properly conducting a clinical study?
- What are the stages of conducting a clinical study?
- How to select an appropriate research center with adequate resources for conducting the study, and what does a Site Qualification Visit entail in practice?
- What does the next step, the initiation of the center, involve? What is the definition of the principal investigator and sub-investigators, and how is their qualification for conducting the study proven? How are study responsibilities assigned in the delegation log?
- What documents are needed to continue the study and begin monitoring visits in practice?
Day 3 (November 2)
Clinical studies must be conducted in accordance with the applicable Good Clinical Practice guidelines and regulatory requirements, which researchers/qualified members of the study team and monitors must be aware of at all times. Monitoring of clinical trials involves tracking and overseeing the quality of clinical trial implementation with the main goal of ensuring the safety of participants and the collection of appropriate quality data on the investigated drug. Here you will learn:
- What is the study protocol, and what is the investigator's brochure?
- What constitutes source documentation, and what is a source data?
- How should the study drug be stored, and how is the use and documentation of the study drug applied? How is the research team’s knowledge of the study drug's characteristics determined?
- What are the requirements for randomizing study participants and unblinding?
- What is an adverse event, and what is an adverse reaction, and how are they reported?
- What are the criteria for an adverse event to become a serious adverse event?
- What are SUSARs, and what is their significance?
- What is the difference between reviewing and verifying source data generated in the study (SDR vs SDV), and how does this look in practice?
- What are protocol deviations, how are they classified, and how is it ensured that the study is conducted in accordance with the study protocol?
- What does retraining the research center entail, and what is a root cause analysis, and why is it important for conducting the study?
- How and who is responsible for communication with the Ethics Committee and the Medicines and Medical Devices Agency of Serbia? How are regulatory bodies informed about the progress of the clinical trial? What are the conditions for prematurely terminating a study?
Day 4 (November 3)
After the successful implementation phase of the study drug, continuous medical care of study participants, and data collection from the study, it is necessary to close the research center where the study was conducted. Electronic systems used in clinical trials greatly assist in conducting the study and ensuring the quality of study documentation and the integrity of collected data. Therefore, the following questions are of crucial importance:
- When can a Site Close Out visit be conducted?
- What does a site closure visit look like in practice?
- What key documents are created and kept at that time?
- How long are documents kept after the study is completed?
- What is an audit, and what is an inspection, and what are the center's obligations in ensuring the conditions for these visits?
- What systems are most commonly used during the conduct of a clinical study, and what role do they play?
- How are documents stored in the Trial Master File, and which documents are kept?
- How does this look in practice?
Day 5 (November 9)
The last day is intended to provide an overview and basic legal and economic knowledge related to clinical trials. Of course, the final day will also involve a recap of everything we have learned in the previous two weekends. Our instructors will make sure to clarify any potential doubts and further explain everything discussed during the course.
Goals
The goal of the training is to empower participants to understand basic concepts in the field of clinical trials, as well as the principles and rules of Good Clinical Practice guidelines. The training aims to demonstrate the practical applicability of these rules and principles.
Target Audience
The training is intended for final-year students or healthcare professionals from various sectors who wish to improve their knowledge of clinical trials. It is also useful for other professions, such as lawyers or veterinarians, given the increasing number of open positions in companies working in this field.
The workshop (theoretical explanations) is conducted through lectures and the presentation of real-life examples. Participants are given assignments for independent work at home. After completing the course, participants will have online (phone and email) support for any questions.
Skills Acquired
After completing the training, participants will acquire competencies in clinical trials necessary to begin working in this industry.
Implementation Method
The workshop (theoretical explanations) is conducted through lectures and the presentation of real-life examples. Participants are given assignments for independent work at home. After completing the course, participants will have online (phone and email) support for any questions.
The training will be conducted through a combination of interactive lectures and case studies.
Program Duration
The training lasts 5 days on weekends, from 10 AM to 3 PM.
Program Cost
The course fee is 200 euros in dinar equivalent based on the NBS middle exchange rate on the day of payment for those who fill out the registration form by October 16, 2024. For those who complete the registration form after October 16, 2024, the fee is 250 euros in dinar equivalent based on the NBS middle exchange rate on the day of payment.
The fee includes attending classes in person at the organizer's premises or via the online platform, and all associated materials according to the course plan and program.
Payment must be made to the organizer's account no. 200-2779020101033-53 held with Postanska Stedionica a.d. Belgrade, or if payment is made outside Serbia, using the IBAN number RS35200277902010100346, Reference number: K-2024
