Study Documentation: Example of a Source Document

2. What Are Source Documents?

2.1. Example of a Source Document

example-source-document

This example of a source document is a form that can be used when a study participant (subject) gives a urine sample:

The study nurse will enter their initials, subject number, and time of urine collection. This information is noted for the first time - it is source data.
The person transporting the urine samples to the lab will note the time of transport and sign with their initials so that it is clear who did this and when.
The lab technician who receives the urine samples signs the form and notes the time.

In this way the process is completely documented including information on who had responsibility for the individual steps along the way (providing an audit trail). The comment column allows specific information to be entered when something unusual occurred. This may help to better interpret the results of the urine analyses.