NCI Expands Westat's CTSU Role, Includes Site Auditing Coordination

2016-11-04

Westat’s role on the National Cancer Institute’s (NCI’s) Cancer Trials Support Unit (CTSU) will be expanding to include major involvement in the central coordination of site auditing activities for

  • National Clinical Trials Network (NCTN)
  • NCI Community Oncology Research Program (NCORP) sites

This work goes to ensuring implementation of an approach that meets federal regulations while improving cost-efficiency and increasing standardization.

Since 1999, Westat has been the prime contractor for NCI’s CTSU, which provides centralized access to a wide range of operational and informatics support services for NCI-funded networks, including NCTN, the Experimental Therapeutics Clinical Trials Network (ETCTN), and NCORP.

This latest task will focus on implementing single-site audits and reducing burden at sites that hold multiple NCTN affiliations, are involved in multiple protocols, and have high to moderate accruals.

Early on, Westat will facilitate establishing and operating the Single-Site Audit Committee (SSAC), charged with developing policy and procedures for single-site audits. Westat will also develop a web-based training module for auditors to ensure that audits are conducted consistently and in accordance with federal and NCI regulations and guidelines. Focus will turn to testing centrally coordinated single-site audits, including identifying patient cases, selecting auditors, organizing audit materials and system access, and scheduling audits. As part of this phase, the project will conduct a pilot audit program involving 40 to 60 sites.

Later on, criteria for single-site audits will be expanded to all high and moderately accruing sites. The SSAC will continue to review procedural issues, update procedures, and assess overall findings from the program.