An electronic study data submission for regulatory must meet a set of predefined rules.
The CDISC study data standards include, but are not limited to, the following:
Study data should be validated before submission using the published validation rules.
An important component of a regulatory review is an understanding of the provenance of the data. That means the traceability of the analysis results back to the CRF data. Traceability permits an understanding of the relationships between the analysis results, analysis datasets, tabulation datasets, and source data. The Data Definition File and the Annotated Case Report Form (aCRF) are instruments in order to support the traceability.
An Annotated Case Report Form in PDF document format maps the data collection fields used to capture subject data (electronic or paper) to the corresponding variables or discrete variable values contained within the datasets.
Legacy (previously collected non-standardized) study data should be converted to standardized study data so that the converted data are traceable and adequate to support review.
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