Step 3: Monitoring a Cancer Prevention Clinical Trial
Identifying and Monitoring Protocol Deviations
A protocol deviation is any noncompliance with the protocol, good clinical practices, regulatory requirements, or Division of Cancer Prevention requirements. This noncompliance is frequently not attributable to error and not punitive in nature; rather it is simply an occurrence that deviates from, or does not comply with, the governing study requirements.
Study participants, study site staff, or the investigator can be the source of the noncompliance. However, it is the site staff's responsibility to identify deviations as they occur and report them to the DCP medical monitor.
By quickly identifying protocol deviations, study staff can more efficiently uncover patterns that may need larger corrective actions, such as changes in communications, operations, or the protocol itself. Section 7 of the DCP Study Site Monitoring Manual (pdf, 24kb) describes the goals and processes for standardizing the identification and reporting of deviations. The form for reporting protocol deviations is found in DCP Consortia Protocol Deviation Form (version 11/18/2005). (doc, 100kb)
