During my work with public research institutions over the last years, I have noticed that many researchers are somewhat confused about the concept of GCP. Here are three common misconceptions I have noticed amongst researchers.
Wrong! Although most researchers have the positive habit of running a pilot study of their actual setup, only a few remember to document the process. Even if your study is not "GCP regulated" - validating your setup can save time. Furthermore, if you face inspection from the authorities on your study, a validation report will help ease their nerves and prove you know what you are doing.
Wrong again! Apart from its primary objective of protecting the rights of human participants in clinical trials it also increases the validity of your study and its data. Think of it like baking a cake without a recipe - it will almost certainly not be consistently good. If you adapt your working methods to GCP and make it your natural way of conducting clinical trials, it will increase the validity and quality of a marginal time investment.
Although many manufacturers say that their system is "compliant" - that only states that if you use the system in a certain way, you as a researcher will be compliant. As such, a system cannot be compliant in its own right. However, the systems do need to have certain functionality, making it possible to be compliant. Are you interested in learning how SMART-TRIAL could benefit your organization? Let's have a chat, and allow us to share various case-stories, to see if you can relate.
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