The Clinical Trials Auditing Team (CTAT) provides ongoing auditing for complex through low risk clinical trials.
Audits are conducted per the outlined review frequency in the DSMP. Routine, random, and “Off Cycle” audits may also be conducted for any cancer-relevant externally-sponsored studies. All auditing activities are performed consistent with ICH GCP guidelines. The CTAT audit process is also intended to evaluate the effectiveness of current training, education and monitoring practices. Findings may translate to modifications in Standard Operating Procedures (SOPs), policies or ROS activities. For information regarding this process please reference the Clinical Trials Audit Manual.
UF IIT or DISC Monitoring Required
Follows the monitoring frequency chart found in the DISC Charter
UF IITs conducted at ARC Sites
At a minimum, the first subject enrolled on a UF IIT protocol at a Cancer Center ARC member site will be audited. This is in addition to the level of monitoring required per assigned monitoring plan for that specific protocol.
At a minimum, each NCTN/ETCTN study will be audited annually. At least 10% or a minimum of 2 cases will be selected from each study.
Externally Sponsored Studies
At a minimum, two externally sponsored studies from each DSG (not including NCTN or ETCTN trials) will be audited annually. At least one case will be selected from each study.
New Principal Investigators
At a minimum, the first subject enrolled and up to 3 additional subjects will be audited within the PI’s first year. These cases are separate from required DISC, NCTN/ETCTN, and/or DSG based auditing requirements.
At a minimum, the first subject enrolled and up to 3 additional subjects will be audited within the coordinator’s first year. These cases are separate from required DISC, NCTN/ETCTN, and/or DSG based auditing requirements.
For information related to the CTAT, please contact Alison Ivey, Administrative Director, at email@example.com or 352.294.8567.