Page 64 - New Employee Glossary

Glossary 64

A formal document that captures and defines the work activities, deliverables, and timeline
a vendor must execute in performance of specified work for a client

Statistical Analysis Plan (SAP)

Document containing a technical and detailed elaboration of the statistical analysis
described in the study protocol.

Strategic Business Units (SBU)

Profit center which focuses on product offering and market segment.

Strategic Financial Trajectory (SFT)

Long-term financial trajectory of the company. Previously known as LRP.

Strategic Harmonization Across Programs to achieve Recruitment, Retention, and
quality Excellence (SHARE)

Clinical trial knowledge sharing forum for study managers.

Study Coordinator (SC)

Personnel at the investigative site that provides assistance to the principal investigator to
execute the study.

Study Management Team (SMT)

Multidisciplinary team that manages the day-to-day operational aspects of a clinical trial
within Global Clinical Operations.

Study Reference Guide (SRG)

Reference document created by the study team that assists the investigator site personnel
with study execution.

Subcutaneous (SC)

Administration of a substance as a bolus into the subcutis, the layer of skin directly below
the dermis and epidermis

Subject Matter Expert (SME)

An individual who is highly knowledgeable and serves as the point of reference for a
particular matter