This course provides you with the clinical data management fundamentals that will allow you to become familiar with the key words & terminology, the associated regulations and the processes used in Clinical Data Management.
Clinical Data Management is one of the Clinical Trial components the most often outsourced to CROs. As such the role of the Clinical Researcher (Clinical project manager, Study lead, Clinical Trial Physician, etc.) is to oversee the expected deliverables of CROs involved in their data management activities.
In that role, you will have to understand the basics of Clinical Data Management vocabulary, concepts, workflow and roles.
This course provides you with the fundamentals that will allow you to become familiar with the key words, the associated regulations and the processes used in Data Management. After this 1-Day course you will never ask yourself about what means a DMP, a DVP, a DB Lock, an eCRF, an Edit Check, CDISC SDTM, Data Transfer and reconciliation, Data Cleaning, ….
Course time09h00 – 17h00
Who should attend
Clinical research professionals, including Clinical Project Managers, Clinical Research Associates, Clinical Trial Physicians, Junior Data Managers, and anyone with a professional interest in Clinical Data Management.
- Understand what clinical data management is & it's role in clinical research
- Clinical Data Management process & activities
- Regulations: Get an overview and understand the regulations, guidelines & standards implemented in Clinical Data Management
- Tools in Data Management
- Roles and responsibility in Data Management
- How to understand a Data management budget
- Be able to explain the terminology used in Clinical Data Management
- Describe the processes of Clinical Data Management
- Learn how to interact with Data Managers
- Be able to oversee an internal or external Data Management Group.
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (0)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (0)
- Data Management and Informatics (6)
- Leadership and Professionalism (1)
- Communication (1)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained