Glossary

A significant departure from the approved trial protocol.

The process of submitting trial data to regulatory authorities for review and approval.

The characteristics, such as age and gender, of the participants in a trial.

Identifying patterns in adverse event data that may indicate potential risks.

Measures to protect the privacy and personal data of clinical trial participants.

Authorization from an ethics committee to proceed with a clinical trial.

A study to determine the highest safe dose of a treatment by gradually increasing doses.

A brief summary of the trial�s objectives, design, and key outcomes.

A site visit by a clinical research associate to review trial conduct and data.

The storage of all records and data after the trial is completed.

Compensation provided to participants for their time and effort in a clinical trial.

Key points in the timeline of a clinical trial, such as recruitment targets or interim analyses.

Natural differences in biological responses among participants.

Criteria for ending a trial early, typically due to safety concerns or overwhelming efficacy.