Auditing and Monitoring

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.

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 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.

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.

Full Audit is a complete and comprehensive review of all protocol-specific activities.  These usually include review of the following components: regulatory, subject cases, and pharmacy records.

Off-Cycle Audits include mock/preparatory audits, focused/process audits, for-cause audits, or Self/Anonymous audit requests

Mock or Preparatory audits are full audits to assist the PI and study team in preparation for a scheduled or anticipated inspection by the FDA, the National Institutes of Health, NCI, NCTN groups, ETCTN, study sponsors, or other regulatory authorities.

Self-requested or Anonymous audits can be made by a PI or DSG (e.g., the PI may be assuming the trial from a departing PI) or a member of the clinical research unit for a variety of reasons (e.g., departure of research staff, on-going findings during external site visits, etc.).

Process/Focused audits are reviews of internal systems and procedures.  These are limited audits to assess compliance and/or reveal the need to change current practice (e.g., eligibility review, RECIST processes, etc.).

For-cause audits are performed when there are concerns or allegations of possible research misconduct potentially affecting subject safety or data integrity.

Monitoring

Monitoring activities are provided for Cancer-relevant IIT clinical trials categorized as interventional treatment utilizing investigational drugs, devices, or medical procedures with funding to support this resource.

Monitoring Frequency

The first visit will occur within 2 months of the first subject enrolled and started treatment.

On-going interim monitoring will occur approximately every 12 weeks and will include review of both local and participating sites.  Visits may occur more frequently if there are concerns identified by the monitor or the sponsor.

The Monitor will review pharmacy records, regulatory compliance and 100% of ICFs, eligibility data, study endpoint data, and SAE/safety data.   Interim monitoring will continue per the study specific Clinical Data Management and Monitoring Plan (CDMMP).

Contacts

For more information related to auditing and monitoring by the CRO-Compliance Group, please contact the team at CRO-Compliance@ufl.edu .