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Join us for a panel discussion with former and current Clinical Research Coordinators on what is defined as source data.
WHAT IS SOURCE DATA?
You would think it would be an easy question to answer, but it turns out there are a lot of misconceptions about what should be considered “Source Data”.
Is it the paper log books that many sites use? Is it the hospital EMR? Is it the EDC? Is it the sticky note that a research coordinator uses to temporarily capture a collection time?
There are significant downstream effects, from source data verification to regulatory filing.
Topics we will discuss:
- Source data has traditionally been paper-based, but how is technology changing what is defined as the single source of the “truth” in clinical trials?
- Is eSource actually “source” if it’s captured first on paper?
- What are the pros and cons of different types of source data?
- What operational and clinical efficiencies are gained by adopting direct data capture?