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What is Automating SDTM ACRF Creation about?

The document outlines the development and implementation of an automated tool for creating Annotated Case Report Forms (aCRFs) to streamline the submission process for regulatory agencies. It discusses the background, pilot testing, and enhancements made to the SDTM aCRF Annotator Tool, which significantly reduces manual effort and increases quality and consistency in data submissions. The tool allows for early aCRF creation, leveraging upstream metadata, and includes features for generating bookmarks and a

Author

aj5203017

Language

EN