Introduction to clinical data management
Course details
- Course duration: 3 hours
- Target audience: Physicians, medical advisors, scientific researchers, representatives of pharmaceutical companies, project managers
- Course dates: Dates for 2025 have not yet been announced
- Course fee (excl. VAT): CZK 3,900 per person
- Course time and venue: 09:00 – 12:00 at the company headquarters – Poštovská 3, Brno
The course will take place if at least 3 participants register. If the minimum number is not met, we will inform registered participants about the course cancellation three weeks prior to the planned start date.
Course introduction
Handling spreadsheets filled with haphazardly collected data can lead to their complete devaluation—or even the need to start data collection from scratch. This course will show you how to avoid that.
Course objective
The goal of the course “Introduction to Clinical Data Management” is to familiarize participants with the basic principles of working with clinical data. The course will enable them to recognize what is important when planning a project, what to pay attention to, how to handle data during the project, and how to proceed correctly. Participants will become aware of common challenges in data collection and management and learn what to watch out for.
This is a shorter, less detailed version of the Clinical Data Management course. It follows the same structure but goes into less depth.
This course is intended for healthcare professionals who are involved in any way in clinical research projects that include the collection or management of clinical data.
The program of this intensive course is structured into three modules.
In the introductory part, we will clarify basic terms and explain why data management is necessary in clinical projects. We will discuss what needs to be considered before starting a project, focus on different types of data in terms of their structure, flow, and further processing. Participants will also become familiar with the rules and documentation required within the project.
During the course, we will go through specific activities related to clinical data management, focusing on the preparatory phase such as designing data collection forms, basics of database design, and planning quality control of collected data. In the final part of the course, participants will learn the fundamentals of advanced data review and proper data handling.
The topics of the three modules are as follows:
What is clinical data management (CDM)
- Definition of CDM
- Different approaches to clinical data management
- Goals and deliverables
What to consider before starting
- Data flow
- Key documents
- Standard processes
Clinical data management process
- CRF design, database setup, system launch for data collection and validation
- Data collection, data validation, discrepancy management, required documentation, reporting, harmonization of adverse event databases, data review
Reference
Interested?
Are you interested in the course or training, but no dates are currently available, the listed date or format doesn’t suit you, or would you like to arrange training for a larger group? Don’t hesitate to contact us at info@biostatistika.cz – we’ll do our best to accommodate your needs.