Clinical Data Integration at the DCRI combines industry-leading innovation and a 35-year record of managing large clinical databases.

The DCRI has been managing clinical data since Duke Medical Center began to create large longitudinal databases in 1968. We now process close to 70,000 CRF pages and 26,000 queries per month for our paper-based trials alone. We have processed 2.5 million pages in our clinical data-management system, Clintrial™, and 1 million pages in Oracle Clinical™. The DCRI locks about 30 databases per year.

We have managed data for Phase I-IV clinical trials for drugs and biologics, device trials, postapproval studies, and quality-improvement registries.

Electronic Data Capture (EDC)
Since 1999, the DCRI has conducted 24 Web-based EDC projects, from 200-patient, 2-site studies to 10,000-patient 60-site registries to 6000-patient, 400-site international trials. The DCRI uses the InForm™ EDC system, fully integrated with our other data-management systems.

We have expertise in all forms of EDC, including Web-based capture, direct-from-patient data capture, fax-based systems, and interactive voice-response systems (IVRS). The DCRI also captures electronic source (eSource) data for many trials, including data from eECGs, continuous hemodynamic monitors, DEXA, pacemaker interrogations, and other therapeutic and diagnostic devices.

We work with clients to implement the most effective data-collection methods for specific data types and collection environments.

Our data management services include:

• Case report form design
• Database design
• Database programming
• 21 CFR part 11 compliant validation process
• Loading, reconciliation and integration of external data
• Medical coding
• Status reporting
• Data entry and cleaning
• Forms management

Industry Standards
The DCRI has implemented 3 trials using CDISC SDM 3.0 and has several projects underway in CDISC SDTM 3.1. Our EDC core lab was featured at the 2004 HIMSS and DIA meetings for showing interoperability between the CDISC SDM and ODM models and the Health Level Seven (HL7) ECG waveform standard.

The DCRI was a founding sponsor of the Clinical Data Interchange Standards Consortium (CDISC), maintains sponsorship, sits on the Industry Advisory Board, and has employees on CDISC model teams. The DCRI also is a partner in the SingleSource project with CDISC.

Among the DCRI's data managers are 5 Certified Clinical Data Managers, several of whom also helped develop the certification exam offered by the Society for Clinical Data Management.

Data Integration and Reporting
We deliver data in client-specific structures and formats. Our trials often involve external data from IVRS, central and core labs, eSource, event committees, and patient reports. For real-time trial-management reports, site payments, and interim analyses, we continuously integrate these data with clinical databases. We also routinely reconcile data against safety-surveillance systems held at the DCRI, with the client, or with a third party.