Documentation In Device Studies – Proving Patient Protection

By Brandy Chittester, IMARC Research, Inc.

I can still recall the voice of my thesis advisor in graduate school saying in regards to our laboratory research, “If it’s not documented, it’s not done!”. Since those grad school days, I’ve had a love-hate relationship with documentation. First as a biomedical researcher in a pre-clinical lab and then as a clinical researcher, documentation, while essential to telling the story of what occurred, sometimes seemed like one big road block to actually getting anything done in a day.

In the lab, documentation served two roles. First, to communicate to the others the details of an experiment, from the exact make-up of test substances, timing of media changes, problems encountered, actions taken, test results, repeat experimental results, and even scribbled calculations. And second, documentation served to prove that we did our job in the event that the job we did got called into question.

The roles that documentation serves in clinical research are exactly the same – to communicate to other health care professionals and to demonstrate the competence with which we do our jobs, and for clinical research, that means being able to prove that subjects were protected throughout the entire clinical research process. As inferred in the terms “clinical research” there are documentation requirements pertinent to a subject’s “clinical” status and there are documentation requirements pertinent to the “research” itself, thus increasing the documentation efforts required exponentially.