Clinical data management course
Course details
- Course duration: 6 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 7,500 per person
- Course time and venue: 09:00 – 15:30 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
Data is a source of information. A source of bias. The key to every project’s success. Data is everything. Without careful collection and processing, we have nothing. And with careless handling, we get distorted results and wasted potential—especially when it comes to clinical data. Want to know how to avoid this? This course will show you the way.
Course objective
The goal of the “Clinical Data Management” course is to introduce participants to the key principles and practical steps for professional clinical data management throughout the entire project. The course provides a comprehensive overview of all essential aspects of clinical data collection and processing, enabling participants to plan data collection effectively, navigate data management processes across the project lifecycle, and understand the regulatory requirements that must be met.
This is a more advanced course building on the “Introduction to Clinical Data Management.”
This course is intended for healthcare professionals actively involved in clinical research projects that include the collection and management of clinical data. It is designed for those who require in-depth knowledge of clinical data management principles: data managers, physicians, clinical and study nurses, scientific researchers, representatives of pharmaceutical companies, and others.
The program of this intensive course is structured into three interactive modules that combine theory with hands-on practice, allowing participants to engage actively.
In the introductory part, we will clarify basic terminology and explain why data management is essential in clinical projects. We will discuss what needs to be considered before starting a project, focus on different types of data from the perspective of structure, flow, and further processing, and introduce the key rules and documents required for compliance within a project.
Participants will explore specific tasks related to clinical data management, with a focus on the preparatory phase, such as designing data collection forms, basics of database design, planning quality control of collected data, reporting options, and the need for harmonizing adverse event databases. Finally, the course will cover advanced topics related to data validation and correct data processing.
The three module topics include:
What is Clinical Data Management (CDM)
- Definition of CDM
- Different approaches to clinical data management
- Goals and deliverables
- What to consider before starting work
Data Flow
- Key documents
- Standard processes
- The clinical data management process
Roles and Responsibilities in CDM
- Preparatory project phase
- CRF design, database setup, Data Management Plan, user training and communication
- Data collection, data review methods, discrepancy management, required documentation, reporting, harmonization of adverse event databases, and 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.