Publication Cover
Accountability in Research
Ethics, Integrity and Policy
Volume 2, 1992 - Issue 1
15
Views
3
CrossRef citations to date
0
Altmetric
Original Articles

The scientific data audit system of the cancer and leukemia group B (CALGB)

, , , , , , & show all
Pages 13-22 | Published online: 11 Jun 2008
 

Abstract

The National Cancer Institute funds and coordinates a large international system of clinical trials, involving many large and small institutions and thousands of patients, which is organized into a dozen cooperative groups. Compliance with the study requirements and data accuracy are monitored at several levels within these collaborative groups. In addition, for approximately 9 years an on‐site data audit process has been conducted by each group. We report the organization and audit methods of one of these groups, the CALGB. In 3 cycles of auditing each CALGB institution, involving over 2300 patients, there have been only 2 instances of scientific improprieties, a rate of only 0.4% in 459 institutional audits. A more worthy result of this on‐site data auditing has been the improvement in compliance with protocol and administrative requirements. Although a system of on‐site reviews of patient records expends both scarce research funds and investigator time, the CALGB has demonstrated the value of such audits for improving the quality of clinical research. The audit system developed by CALGB could be used as a model for others to verify clinical research.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.