AN OVERVIEW OF CLINICAL DATA

REPOSITORY (CDR)

A presentation by

Netrah L

What is CDR? A Clinical Data Repository (CDR) is a real time database that consolidates data from a variety of clinical sources to present a unified view of a single patient.

It is optimized to allow clinicians to retrieve data for a single patient or to facilitate the management of a specific clinical trial.

Typical data types which are often found within a CDR include: laboratory results, patient demographics, pharmacy information, radiology reports, hospital admission, transfer dates, ICD-9 codes, discharge summaries & progress notes.

Need of CDR……Key issues faced by the industry today in the clinical trial and clinical safety space include:

• Non-uniform sets of data from EDC, CRO, Purchased Trial. (Patient Data, Metadata, Financial Data)• Data not integrated between Clinical Trial & Clinical Safety• Performance Metrics – delay in getting• Safety Signal Detection not effective on insufficient & poor quality of data.• Double Data Entry• Reporting is mostly manual, time consuming & costly.• Manual reconciliation of data• High down time & maintenance window.

CDR Implementation- Challenges Faced : Storage capacity Computing powerReliability Accessibility of the dataElectronic interface between all the ancillary data sources and the CDRNetwork connectionSemantic mappingUser interface

Key features required of the CDR architecture

Provision for a standard format for information collation and representation.

The data coming from various internal and external source systems need to be verified before consolidation and aggregation.

There is a definite need for storing history data. This requirement will warrant the need for establishing a Data Warehouse that can store time-varied data. Time dimension would need to be implemented or a history needs to be maintained in the staging area.

Key features required of the CDR architecture – continued

There is a need for generating reports of an analytical nature. This will warrant the use of a best-of-breed OLAP tool running against a dimensionally modeled Data Repository.

There is a need to provide accelerated response times for the reports. Report using a dimensionally modeled system in which case the data access would be a simple query against the star schema can accelerate responses.

Clinical Data Repository Framework

Data SourcesThe CDR system extracts data from both the structured and unstructured datasets.

Structured data sources - CRO Data, EDC Data, Safety data, AERS data, Prescription Data, Patient Data, Purchased Trial data, Dictionary Data and Coding Systems. Unstructured datasets - the documents such as IVRS.

The Source System Interface Architecture Component manages the extraction, verification and integration of “changed data” from the Source System into the “Interface Design Framework” and facilitates its transfer to the Data Staging Subcomponent.

Data Sources

Staging Layer

The key functionalities of this layer are:1. Discard any unwanted data2. Convert to common data names and definition3. Calculate summaries, aggregation and derived data4. Establish defaults for missing data5. Accommodate source data definition changes

Data Warehouse Layer

Data Warehouse Layer

Reporting Layer

Reporting Layer - Any standard OLAP tool

Entire CDR Framework

SAS Tools for Clinical Data Repository

CDR Framework with SAS Components

Oracle Life Sciences Data Hub

CDR Framework with Oracle Life Sciences Data Hub

Benefits of CDRAbility to pool data across phases Review safety data across products Analyze data trends using a review tool Use data mining for targeted populations Allow project teams to oversee and manage clinical trials through a single user interface with role-based access Get rapid, near real-time access to data on clinicians' desktops Respond to regulatory authority questions quickly and confidently Use data to make go/no-go decisions in product development Look for data trends on marketed products for best practices in patient care Provide access to investors and clinical development partners to make business decisions