Clinical Trials Auditing Team
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 “For Cause” 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.
|Protocol Prioritization||Audit Frequency|
|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 UFHCC ARC member site will be audited. This is in addition to the level of monitoring required per assigned monitoring plan for that specific protocol.|
|NCTN/ETCTN Trials||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.|
|New Coordinators||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 Cause||As needed|
For information related to the CTAT, please contact Alison Ivey, Administrative Director, at email@example.com or 352.294.8567.
To request an audit please complete the Request an Audit Form below