Page 19 - New Employee Glossary

Glossary 19

organization (also called reference data); manages the hierarchies of data in the Hyperion
cubes.

Data Review Guidelines (DRG)

A study-specific document that describes all of the automatic and manual data checks used
by Data Management during data review.

Data Safety Monitoring Board (DSMB)

Multidisciplinary group convened on a regular basis to monitor, review, and evaluate drug
safety issues regarding any Biogen investigational or commercial product, which may impact
the safety of patients and clinical subjects.

Data Standards Team (DST)

Creates company-wide data standards for the facilitation of data collection, database
design, and statistical analysis of clinical trials, utilizing industry standards and best
practice.

Database Lock (DBL)

An event defined as all data in a clinical trial received by the EDC and verified by a CRA.

Demand Plan

Planning application for assistance in creating a manufacturing demand plan; rolling 24
month forecast. This cube is used by the Supply Chain and Manufacturing groups.

Depreciation

An expense recorded to reduce the value of a long-term tangible asset. Since it is a non-cash
expense, it increases free cash flow while decreasing reported earnings. Depreciation is
used in accounting to try and match the expense of an asset to the income that the asset
helps the company earn.

Development Core Safety Information (DCSI)

Safety information for an investigational product. It applies to all uses under investigation.
The DSCI serves as the consolidation of key safety issues described in more detail in the
main body of the IB.

Diffuse Large B-Cell Lymphoma (DLCBL)

Type of Non-Hodgkin’s Lymphoma affecting B-cells