Industry

This part asks how the work meets the conventions of regulated drug development. It belongs to the second quarter and is a branch rather than a step: the capstone draws on it but does not require it, and a reader headed for academic research may postpone it. Pharmaceutical-track students should treat both chapters as core.

• 27  Clinical Data Standards: CDISC, SDTM, and ADaM traces a trial’s data from the case report form through SDTM and ADaM to the tables of a clinical study report, and derives two ADaM datasets in R.
• 28  SAS for R Programmers teaches enough SAS to read a program and its log, write the R equivalent, and predict where the two fits of one model will disagree.

If the quiz at the start of a chapter is easy, skip to the next.