Glossary

The study of how genes affect an individual's response to drugs.

Ongoing review of trial data to ensure safety and integrity.

A standard treatment used as a comparison in a clinical trial.

The group in a clinical trial that receives a placebo or standard treatment for comparison.

Studies where the probability of harm or discomfort is no greater than everyday experiences.

An adverse event that results in death, hospitalization, disability, or other significant harm.

Research conducted to determine if a clinical trial is practical and achievable.

The process of assigning participants to treatment or control groups.

Strategies to reduce potential risks in a clinical trial.

A professional who monitors and supports clinical trial operations at sites.

Remote review of trial data and processes to ensure compliance and identify issues.

A document summarizing information about the investigational product for researchers.

A trial conducted to gather data for a new population, region, or indication.

A study design where participants receive multiple treatments in a specific order.