The Start-Up Process for Sponsors
All studies involving human subjects must be reviewed by the Facility Research Committee (FRC). The FRC is an internal Facility-specific committee designated to review each proposed research study in order to determine whether the study is appropriate for the Facility and determine if the Facility has the necessary equipment and resources to conduct the study.
The FRC evaluates each study’s impact on the hospital and/or practice, including staffing, patient safety, adequate resources (i.e. nursing, pharmacy and ancillary services), supplies, financial costs and reimbursement. The FRC also evaluates each study against the Facility’s mission, vision and strategic plan.
The Facility Review Committee serves as an evaluating body for the operational, financial and administrative feasibility of the study. FRC review and approval are a prerequisite to consideration by the IRB. In this regard, the FRC functions as a required “ancillary committee” and the policy applies that studies may not be submitted to the IRB until all applicable “ancillary committee” approvals have been given.
The FRC is a multidisciplinary committee with representatives from areas involved in the performance and conduct of human subject research, including, but not limited to, Patient Access Registration, Finance, Pharmacy, Nursing, Imaging, Revenue Cycle and Medical Staff Services. At least one member of Facility’s A-Team shall serve as a voting member of the FRC. The Facility’s Risk Manager and Hospital Compliance Officer are ex-officio, non-voting members of the FRC. Facility’s CEO is responsible for appointing all members. A roster has been created designating persons who are voting members of the FRC.
The FRC is charged with the responsibility to ensure that studies conducted under the auspices of each Facility meets standards for scientific rationale, specific aims, study endpoints and design, proposed analysis, ability to accrue subjects, adverse event reporting requirements, and plans for data and safety monitoring. The FRC reviews all proposed clinical trials for merit with the exception of those designated as exempt on the basis of external peer review, such as those sponsored by designated cooperative groups.
The FRC also assigns a level of risk (low, moderate or high) to institutional trials that will be monitored by the Quality Assurance Division of CARE or internally by the Data and Safety Monitoring Committee (DSMC). This risk rating determines the frequency of DSMC review. The FRC also determines any exceptional requirements for specialized expertise in conducting DSMC reviews.
The FRC shall communicate its decisions in writing to the Facility CEO, the Principal Investigator and the IRB.
The electronic Contract Approval Term Sheet (eCATS 4.0) system consists of a web-based form submission, review, and approval process, as well as a Contracts Archive capable of storing and managing agreements with email tickler notifications.
Users will prepare and submit eCATS packages through an interactive form accessible via eTenet. All of the supporting documentation will be electronically uploaded from files or scanned images. Checklists, templates and special considerations are provided to further guide the user in preparing the eCATS package. The eCATS application will distribute notifications via corporate email for the appropriate personnel’s review and approval. Once a package is approved and executed, the agreement will be archived for agreement management and historical reference within the application.
All CARE clinical trial agreements are submitted through eCATS and routed for approval by Corporate Quality Management, Legal Counsel and Tenet Healthcare, Florida Region.