study feasibility

How likely it is that a study can be completed.

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Serious Adverse Event (SAE)

A health issue that happens during a study, and can lead to hospital care, lasting medical problems, life-threatening conditions, or death.

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repository (research)

A collection of participant data and samples stored for future research.

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procedures (for participants)

The activities that participants will be asked to do during the research study.

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post-market surveillance

Continuing to collect and analyze information about the risks and benefits of medicine and devices after they have been approved for patient use.

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pilot study

A small study that is done to test a process before starting a larger study.

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minor

Someone considered too young to give legal consent.

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master protocol

An overall research plan that guides sub-studies that have their own research questions.

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database (research)

Information that has been collected and organized to be used for research.

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concomitant medications

Non-study medicines that are allowed to be taken at the same time as the study treatment.

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