Glossary

Permission from a research institution to conduct a clinical trial.

A systematic review of trial processes and data to ensure compliance with regulations.

The extent to which participants follow study procedures and treatment instructions.

Guidelines outlining standardized trial procedures.

A potential safety concern identified during a trial that requires further investigation.

A group that independently evaluates outcomes to ensure objective reporting.

A digital system for collecting and managing trial data.

Changing the dosage of a treatment during a trial based on participant response or safety concerns.

Laboratory and animal studies conducted before human trials to assess safety and effectiveness.

Stopping treatment or participation in a trial before its scheduled completion.

The assessment of a clinical trial�s ethical aspects to protect participants.

The level of seriousness of an adverse event, ranging from mild to life-threatening.

Tracking participants� compliance with trial instructions and treatments.

The standard treatment or placebo used as a reference in a clinical trial.