Glossary

A protocol for regularly reviewing trial data to ensure participant safety and data quality.

Research conducted after a drug is approved to gather more information about its safety, efficacy, and long-term effects.

A continuation of a study beyond its original timeframe to collect additional data.

A substitute measure used to predict clinical outcomes in a shorter timeframe.

The process of reviewing and confirming outcomes in a trial to ensure accuracy.

The process of documenting and submitting adverse events to regulatory authorities.

When a participant voluntarily or involuntarily exits a clinical trial.

The process of listing a trial on a public database for transparency and accountability.

A method used to prevent bias by keeping treatment assignments hidden from participants or researchers.

The effect one medication may have on the activity or metabolism of another.

Specific characteristics participants must have to join a clinical trial.

The finalization of data in a clinical trial to prepare for analysis.

Specific characteristics that disqualify individuals from participating in a clinical trial.

The range of drug dosages that provide effective treatment without causing significant side effects.