Reasons to attend
This course provides you with the fundamental Clinical Data Management concepts to allow you to successfully understand, setup, and oversee Data Management activities of a study in a Clinical Operation or study management function.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Classroom:1-Day face-to-face: 09:00 - 17:00
Online:2 webinar sessions of 3 hours
Clinical Data Management is one of the Clinical Trial components the most often outsourced to CROs. As such the Clinical Researcher (Clinical project manager, Study lead, Clinical Trial Physician, etc.) must ensure that the (electronic) Case Report Forms design and the used Electronic Data Capture (EDC) System, and other relevant data captures and processing steps meet regulatory and technical requirements of your study and that you are receiving the relevant deliverables during study conduct and after database closure.
In that role, you will have to understand the basics of Clinical Data Management terminology, and concepts to properly define and oversee the expected deliverables, e.g. database build and ongoing Data Management activities. Poorly defined tasks and responsibilities can lead to unexpected delays, budget overrun, make analysis, report writing, and submission of the data difficult, and can increase inspection risk.
This course provides you with the fundamentals of key Data Management terminology, processes, and deliverables, the associated regulations, and what you should consider when selecting a Data Management CRO or EDC System, and where you should pay attention in setting up contracts and defining timelines.
After this course you will have a clear picture of what to look at during vendor selection and contracting of a DM provider, where your involvement as a Clinical Project Manager or Sponsor is essential, and what e.g., DMP, eCRF, DB Lock, CDISC SDTM, Data Transfer and reconciliation, Data Cleaning means and understand which areas are critical from study conduct and also what is relevant from a Sponsor oversight perspective.