Poster
Widel-KirbyPhUSE-CSS18s.pdf
March 4, 2018
PhUSE/CSS 2018 -- Ensuring that ADaM datasets conform to CDISC standards and FDA expectations is often done through expert review after content is complete. That retrospective approach may result in a quality final product, if there is enough time to do the same work twice (once incorrectly and once correctly). Moving back a step and prospectively planning for success by having a subject matter expert guide ADaM implementation before mapping starts can help prevent issues and avoid re-work.