electronic case report tabulation
- Definition
- CRTs provided in electronic format for esubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. Becoming obsolete, being replaced by SDTM.
- Abbreviation for
- eCRT
- Related Term
- case report tabulation
- study data tabulation model
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