Whether you’re working on a big pharma clinical trial or a multi-site research study, changes will pop-up while the study is running. I have yet to find someone who enjoys changing electronic case report forms (CRFs), subject numbering schemes, or modifying user permissions in the middle of a study, but change requests will come and how you react to these changes defines the robustness of your design. It’s frustrating, and I’ve found that they are unfortunately a fact of life.

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