Standard operating procedure (SOP)
In Documents & records
A standard operating procedure is a written instruction describing how an organization performs a recurring task consistently. In clinical research there are SOPs for consenting, monitoring, safety reporting, archiving, and much more. Staff must be trained on the SOPs that apply to their work, and that training must be documented.
Why it matters
In an audit, the first question is usually "what does your SOP say?" and the second is "can you show you followed it?".
Example
A CRA cannot start monitoring visits until the training record shows they were trained on the current version of the monitoring SOP.
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Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.