The document outlines the key functions and components of a clinical research data management system, including standards management, a high performance computing core engine, data storage systems, analysis workspaces, analytics and visualization tools, and collaboration features to support study design, publication, and regulatory activities across a network of sponsors, affiliates, CROs, and research partners. It also references the management of data quality, permissions, resources, and dictionaries within the system.

1. Service Functions
Standards
Core Engine HPC
Sponsors
Affiliates
CROs
Partner Firms
Research
Institutes
Labs
AROs
Sponsor
EDC
Systems
Other
stores
EDC
systems
Other
stores
Interchange
Arrival Raw
Data Store
Formal and
Informal Analysis
Workspaces
Near-Final
Data Sets
Master DataMeta Data
Industry
Standards
Partner
Standards
In-House
Standards
Industry
Ontologies
MDMCTMSMDRs
High
Performance
Analyses
High
Performance
Tools
Modular User Functions or Direct Applications
Analytics Visualization Publishing
Data Quality
Management
Collaboration
Interchange
Monitoring Alerts
Visual
Tracking
Code Macros Wizards
PERMISSION APPLICABILITY
COMPLIANCE METRICS
CASE MANAGEMENT
RESOURCE PERFORMANCE
DICTIONARY MANAGEMENT
Study Design
Publication
Out-Licensing
Regulatory
Response
In-Licensing
Trial
Transparency
Networked
Collaboration
Future use
MDMMDM
Stats Tools
An Industry View