Page 11 - New Employee Glossary

Glossary 11

Core Study Management Team representative from Data Management responsible for all
aspects of data collection and cleaning within a study.

Clinical Data Processor (CDP)

Responsible for processing data entry, and imaging of data from Case Report Forms,
electronic images, media received from a clinical site, and additional sources in accordance
with protocol-specific guidelines.

Clinical Development Plan (CDP)

Describes the suite of trials and their related timing planned for a clinical program. Data
Management personnel responsible for data entry, scanning and archiving.

Clinical Development Team (CDT)

Determines the need for a study and conceptualizes the basic study design.

Clinical Integrated Data Repository (CIDR)

A centralized repository for standardized clinical data.

Clinical Laboratory Improvement Amendments (CLIA)

Laboratory certification

Clinical Material Request Form (CMR)

A request for clinical materials, used to communicate clinical trial information from Clinical
Operations to Labeling.

Clinical Monitoring Plan (CMP)

Agreed upon plan describing the frequency of site monitoring by the Clinical Research
Associates and remediation plans should an issue be discovered.

Clinical Operations Management Planning Analysis System (COMPAS)

A clinical trial management system which assists in the management of clinical trial
operations including investigator selection, patient enrollment, regulatory document
collection and tracking, trial budgeting, grant payments, project management, and
management reporting.