Chapter 2: Getting Started from the Case Report Form
An electronic Case Report Form (eCRF) is used to collect all clinical trial patient information. It’s critical to understand that all of the values entered on the eCRFs need to be collected or converted to standard, pre-specified text, which is called controlled terminology (CT). In the Demographics domain, for example, the eCRF values for Sex are “Male” and “Female”; however, the CT for these are “M” and “F”, respectively. The link to the CDISC Terminology is located here: https://datascience.cancer.gov/resources/cancer-vocabulary/cdisc-terminology.
The Data Management group drafts the CRF, which is then reviewed by the statistical programmer in conjunction with the entire cross-functional ...
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