masking (study treatment)

Hiding or covering what the study treatments look like so participants cannot tell the difference.

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Investigational Device Exemption (IDE)

An approval given by the United States Food and Drug Administration to use a medical tool, instrument, test, or method in a study that enrolls people.

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investigational device

A medical tool, instrument, or test that has not yet been approved for the reason being studied in the research.

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human subject

A person who participates in a research study.

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eSignature

A way for a person to sign their name using a computer or device, instead of signing on paper.

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decentralized clinical trial

A type of research study where some or all of the participant‘s study-related activities happen at places other than a single study site.

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crossover trial

A type of study where each participant receives all the study treatments but in a randomly assigned order.

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case-control study

Research that uses existing data to compare a group of participants with a disease or trait to a group without the same disease or trait.

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blinding

A way to keep participants, and often study staff, from knowing which study treatment a participant is assigned.

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