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Compliance In Focus
Posted by Sandra Maddock on Thu, Dec 13, 2012

“If it is Not Documented, It Was Not Done”

In clinical research this phrase is used to emphasize the importance of complete and accurateIf it is Not Documented, It Was Not Done documentation to site staff.  Still, every year we see that FDA issues multiple warning letters which cite, “You failed to maintain adequate and accurate records.”

It is easy to assume that those in research understand that accurate documentation is one key component to a successful trial.  According to 21 CFR 812.140, an investigator shall maintain accurate, complete, and current records relating to the investigator’s participation in an investigation.  In consideration of this requirement, one may wonder why there are so many short falls when it comes to documentation.  Are the words “accurate” and “complete” difficult terms to grasp?

An investigator should establish a plan for document management at the onset of a clinical trial.  In collaboration with the research team, the investigator can confirm the what, when, where, how and by whom all the study data will be collected, recorded and stored.  The investigator must always keep in mind that the research records are the source documents for the verification of the research by multiple agencies: institutional agencies (i.e., IRB), sponsor-related agencies, and governmental agencies, in particular the FDA.

Keeping these points in mind, complete and accurate documentation leads to:

  • Ease in the validation of data
  • Fulfills obligations to the sponsor
  • Provides a solid ground for research practice;

Adequate planning at the onset leads to successful record-keeping throughout the study. This will ensure that the data is current, consistent and can be used in the over all analysis of the study. We have a whitepaper that takes a look at how to think through situations to ensure that your documentation adequately proves that you protected subjects throughout the study. 

Have you encountered a site with improper or lack of proper documentation? We want to hear your experiences.

Photo Credit: 64MM


Topics: 21 CFR 812.140, Documentation in Device Studies, Source Documents, FDA Warning Letters


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