Page 12 - New Employee Glossary

Glossary 12

Clinical Packaging Order (CPO)

A request for packaged clinical supplies used to communicate clinical trial operations from
Ops to Labeling.

Clinical Program Lead (CPL)

Global Clinical Operations member responsible for oversight of a clinical program.

Clinical Programmer (CP)

Ad hoc Study Management Team representative from Data Management that is responsible
for designing, developing & maintaining the Clinical Data Management system.

Clinical Research Associate (CRA)

Someone who monitors clinical trial standards

Clinical Research Board (CRB)

Committee that governs clinical research at Biogen.

Clinical Research Country Associate (CRCA)

Country Management & Field Operations member who supports the management of clinical
operations at the country level.

Clinical Research Country Lead (CRCL)

Country Management & Field Operations member responsible for the management of
clinical operations at the country level.

Clinical Research Manager (CRM)

Assumes overall responsibility for the preparation of protocols and Case Report Forms,
finalization of monitoring and data management options, ethics committee approval,
development of recruitment strategies to increase patient randomization into the trial, the
provision of clinical trial materials, and management of the trial.

Clinical Study Report (CSR)

A document that describes the objectives, design, rationale, methodology, statistical
methods for analysis, data, results and conclusions that can be drawn from the data
collected in a clinical trial.