Clinical Research Glossary

sham (procedure) sham (procedure)

CDISC

A medical process that looks and feels like the study treatment, but is not expected to have a health effect on the condition being studied.

Example of sham (procedure) in a sentence

A sham procedure in a study keeps the participant and the study team from knowing whether the participant received the active or inactive procedure.

More Info

A sham procedure is sometimes referred to as a fake or pretend procedure. A sham procedure could be done in research studies where it might be difficult keep the participant from knowing whether or not they received the study intervention.

A participant who joins a research study that involves a sham procedure should not be able to tell whether they got the sham or the active treatment.

For example, a study that involves a surgery to insert an implant could include a group that is randomized to receive a sham procedure. That way, all participants go in for surgery but they do not know whether they will receive the implant or not. A sham procedure is done to prevent bias, or the idea that a participant could expect the device to be helping them if they know for sure that they got it.

Other info to think about when joining a study

You could see the term “sham (procedure)” if you are considering joining a study that is testing an intervention that does not have any other way to keep you from knowing whether you are receiving the active or inactive procedure. If you join a study with a sham procedure, you should not be able to tell if you got the real treatment or the sham.

You should feel free to ask any questions you have about why a sham procedure is being used, what the risks are, and whether there will be an option to get the active treatment in the future.

The study team should discuss any known safety issues with you. For example, if the study involves an implant, you should ask if it contains metal. This is important because doctors need to know if you have metal in your body before you have certain tests, like an MRI.

Version 2.0 September 2024

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