The Cancer Trials Support Unit (CTSU), in conjunction with the North Central Cancer Treatment Group (NCCTG), is testing the feasibility and advantages of centralized data collection within the Cooperative Group environment. This project utilizes Remote Data Capture (RDC), which permits sites to enter patient-level data into an Oracle Clinical database over the Internet. RDC is also used to notify the sites of discrepant data and provide tools for data correction online at the point of entry.

The CTSU is using RDC with the NCCTG's N0147 study. This study is a randomized phase III trial of Irinotecan (CPT-11) and/or Oxaliplatin (OXAL) plus 5-Flourouracil (5-FU)/ Leucovorin (CF) after curative resection for patients with stage III Colon Cancer. The protocol was activated on February 10, 2004 and is expected to enroll 4,800 patients.

All NCCTG sites that participate in N0147 are required to register their site, enroll patients, and submit data (using RDC) via the CTSU (whereas typically an NCCTG site would enroll patients and submit data directly with NCCTG). Non-NCCTG sites who wish to participate in N0147 do so through the CTSU and are not required to submit data via RDC, though they may do so upon completion of training in the use of the software. Non-NCCTG sites are encouraged to participate. Training provides qualification for any of the other protocols available through RDC.

The CTSU has developed the N0147 study database in Oracle Clinical in close collaboration with NCCTG. Data entered into the CTSU database will be transmitted electronically to the NCCTG on a regular and frequent basis using the Clinical Data Transfer System developed using XML technology. The NCCTG will be responsible for statistical quality control, medical review, and interim and final analyses. Timeliness and accuracy of data submission will be monitored by the CTSU with data quality assurance reports being provided on a regular basis.

All N0147 site registrations will be done through the CTSU/RSS (Regulatory Support System). Registration will require submission of the CTSU IRB Certification Form, IRB Regulatory Approval Transmittal Sheet, and IRB-approved consent form. Sites can check the status of their site registration by visiting the 'RSS' tab on the members' side of the CTSU web site at http://members.ctsu.org.

For more information regarding RDC and CTSU, please contact the CTSU Help Desk at 1-888-823-5923 or CTSUContact@westat.com