SAP Writer

A protocol and a Word template in, a Statistical Analysis Plan out. Every statement is traced to the protocol; what the protocol does not say becomes an open point for you.

New draft

Recent drafts

none yet

Assistant

uses the Thinking pick above

How it works

  1. The protocol is read to text (the document convertor, pdf2md second).
  2. Every fact is recorded with its quote and verified against the protocol's text; a fact whose numbers are not in its quote is dropped.
  3. The study is placed among the studies learned from: design, phase, therapeutic area, intervention type, drug class, population, sponsor.
  4. Every template section is planned: which facts it uses, what is convention, what is an open point.
  5. Each section is written from its facts only, following the practice of the newest similar SAPs, then audited: every number must come from a fact.
  6. The Word document is built into your template, with an appendix of open points and the source trace.