Page 63 - New Employee Glossary

Glossary 63

Pays a percentage of your covered earnings for up to six months if you are unable to work
due to an illness or injury.

Site Information Form (SIF)

Form utilized in study start up that gains study related feasibility data from the site prior to
site selection.

Site Initiation Visit (SIV)

First monitoring visit conducted by the CRA at an investigator site. The purpose is to educate
the site on how to perform all aspects of the study.

Site Selection Visit (SSV)

Site visit that assesses the suitability and capability of a site for participation in a clinical
trial.

Software Development Lifecycle (SDLC)

A process for planning, creating, testing, and deploying an information system. Provides a
repeatable, predictable process that improves productivity and quality.

Source Document Verification (SDV)

Activity performed by the CRA that ensures that data entered in the eCRF is consistent with
what is listed in the source documents.

Special Protocol Assessment (SPA)

A declaration from the Food & Drug Administration (FDA) that an uncompleted Phase III
trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.

Standard Operating Procedure (SOP)

The specifications and instructions to be followed throughout any operation, process, or
activity

Standard Operating Procedure Steering Committee (SOP SC)

Team responsible for developing Biogen's SOPs and coordinating their respective review by
the broader reviewers.

Statement of Work (SOW)