Glossary

A document outlining how participant safety will be overseen during the trial.

The documentation and communication of drug safety data during and after trials.

An outcome measured without intervention by researchers.

The identification of biological indicators that can predict or monitor treatment outcomes.

A continuation of a trial where all participants receive the active treatment.

An additional phase of a clinical trial conducted to gather more data or extend treatment access.

The process of educating clinical trial investigators on protocols and regulations.

Efforts to keep participants engaged and active throughout the trial.

The ability of a treatment to produce the desired effect under controlled conditions.

A method or instrument used to gather information in a clinical trial, such as surveys or software.

A group responsible for monitoring the overall conduct of a clinical trial.

Research conducted on biological samples outside the living organism.

The process of signing up eligible individuals to participate in a clinical trial.

A committee that reviews and approves clinical trials to ensure participant safety and ethical standards.