SOP
Meaning of SOP: Written so that the same task produces the same result whoever performs it, and so that anyone can later check that it did.
Definition of SOP
An SOP, or standard operating procedure, is a written document setting out the steps for carrying out a specific task the same way every time. SOPs are used wherever consistency matters, including laboratories, clinical research, hospitals, pharmacies and manufacturing. Each describes one defined process in enough detail that a trained person can follow it without further instruction.
What does an SOP contain?
The format is deliberately dull and predictable. A typical document names the procedure, states its purpose and the range of situations it covers, identifies who is responsible for each step, lists any equipment or materials, and then gives the steps in order. It carries a version number and an effective date, records who approved it, and specifies how the work is documented once done. Superseded versions are retained rather than discarded, so it remains possible to establish which instructions were in force when a piece of work was carried out. Review at set intervals keeps the document aligned with how the work is actually performed.
Where are SOPs used in clinical research?
| Area | Example of what an SOP covers |
|---|---|
| Participants | How people are screened, and how consent is obtained and recorded |
| Data | How information is collected, corrected and stored |
| Documents | How submissions to an ethics committee or review board are prepared and renewed |
| Materials | How study drug is received, stored, dispensed and accounted for |
| Safety | How an unexpected event is recorded and reported |
Written procedures of this kind are an expectation of good clinical practice, the international standard for the conduct of a clinical trial. The name of the body that reviews the ethics of a study differs between countries, so an SOP is written to the local requirement rather than to a single universal one.
How does an SOP differ from a protocol or a guideline?
A protocol describes one particular study: its question, who may take part, what will be done and how the results will be analyzed. An SOP describes how the organization performs a recurring task across every study it runs. A guideline recommends an approach and leaves room for judgment, whereas an SOP prescribes steps and expects them to be followed. Because deviation is a departure from something written, SOPs are also what makes quality assurance possible: an auditor compares what was done against what the document said should be done.
Also known as
Used in a sentence
The research coordinator followed the site's SOP for participant enrollment.
Good to know
An SOP describes how a recurring task is to be performed across an organization, whereas a protocol describes a single study, a distinction that determines which document an auditor compares the work against.