phase

A step in the overall clinical research process to test a new drug, device, or treatment.

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Pharmacokinetic (PK) study 

A study that measures what happens to a drug in a person’s body over time.

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pharmacovigilance

A process to detect, review, and make decisions about drug safety to protect patients.

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Pharmacodynamic (PD) study

A study that measures the effects of a drug on the human body.

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periodically

At regular or expected times.

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peer review

Evaluation by independent experts.

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Patient Reported Outcomes (PROs)

The information that patients share about their own health or well-being to answer questions in a study.

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participate

To take part in a study.

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informed consent

The process of learning and discussing the details of a research study before deciding whether to take part.

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inclusion criteria

A list of requirements a person must meet to take part in a study.

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