Page 13 - New Employee Glossary

Glossary 13

Clinical Trial Administrator (CTA)

Member of Global Clinical Operations that supports the Clinical Teams with administrative
activities.

Clinical Trial Agreement (CTA)

Contract between site and the sponsor which both parties sign indicating their participation
in the trial as an investigator site. Clearly delineates expectations of the Principal
Investigator.

Clinical Trial Coordinator (CTC)

Member of Global Clinical Operations that supports the day to day operations of a clinical
study.

Clinical Trial Management Meeting (CTMM)

Clinical Trial Knowledge Sharing Forum for all members of the clinical teams.

Clinical Trial Manager (CTM)

Member of Global Clinical Operations that manages the day to day operations of the study.

Clinical Trial Review Board (CTRB)

Cross-functional group in Medical Research that reviews and supports clinical
protocol/protocol amendment concepts.

Clinical Trial Review Committee (CTRC)

A committee led by Medical Affairs that reviews all post development, non-registration
studies involving collection of data on human subjects, basic science studies, and/or
material transfer agreements on commercially approved products.

Clinical Trials

Research studies performed in people that are aimed at evaluating a medical, surgical, or
behavioral intervention; primary way that researchers find out if a new treatment is safe and
effective in people.

Clinical Trials Document (CTD)

Documents that are essential to conducting a clinical trial.