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 and technologies used in Clinical Data Management.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- Course time: 09:00 - 17:00
Course Long DescriptionClinical Data Management is one of the Clinical Trial components that is 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 Data Management Terminology, the associated regulations, as well as the processes and IT systems used in Data Management. After this 1-Day course you will never ask yourself the meaning of a DMP, a DVP, a DB Lock, an eCRF, an ePRO, an Edit Check, CDISC SDTM, Data Transfer and reconciliation, Data Cleaning, and understand which areas are critical from a Sponsor oversight perspective.