WIA Clinical Trial Data Standard Guide

A clinical trial is an experiment on people. Its output is not the new medicine itself but evidence about that medicine, and that evidence exists only as data. This chapter explains where clinical trial data comes from, which design decisions shape it before the first subject is enrolled, who is responsible for it along the way, and how the WIA-BIO-010 v1.0 standard and this book are organized around it.

Every clinical trial starts as a document, the protocol . The protocol states the question the trial will answer, who may take part, what each subject will receive, which measurements will be made at which visits, what the primary endpoint is and how it will be analysed. From that point on, the trial is a long chain of transformations. A nurse or investigator records an observation on a case report form (CRF), usually inside an electronic data capture (EDC) system. The data manager cleans it through edit checks and queries. The database is locked. Statistical programmers convert the raw records into standard tabulation datasets and then into analysis datasets. Statisticians produce tables, listings and figures. The sponsor writes a clinical study report and assembles a regulatory submission. A regulator reviews it and, if the evidence is convincing, approves the product.