Page 18 - New Employee Glossary

Glossary 18

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Data Analysis & Reporting Team (DART)

A cross-functional subset of the Study Management Team consisting of members from
Biostatistics, Data Management and Medical Writing.

Data Clarification Form (DCF)

Used for recording, tracking and resolution of data discrepancies. The form is forwarded
from Biogen, or representative, to the investigator for clarification of discrepancies.

Data Collection Instrument (DCI)

A collection of one or more data collection modules in Oracle Clinical that model a specific
case report form

Data Collection Module (DCM)

A collection of one or more question groups in Oracle Clinical that models a section of a case
report form

Data Management (DM)

Department responsible for managing the data of Biogen's clinical studies.

Data Management Plan (DMP)

A study-specific Data Management document that defines the data management process
throughout the conduct of a clinical study.

Data Management Project Manager (DMPM)

Core Study Management Team representative from Data Management for studies
outsourced to Data Management Functional Service Provider. Responsible for overseeing
Data Management activities.

Data Relationship Management (DRM)

Manages the reference data used to support applications and analysis; a set of processes
and tools that consistently define and manage the non-transactional data entities of an