About Us

Organizational Overview

Clinical Research Initiation Services ("CRIS") provides the University of Miami's School of Medicine with an organized clinical research support function serving members of the UM's Clinical Research Program ("CRP"). The CRP is a broad term that refers to the greater clinical research community at the University of Miami's School of Medicine and includes PIs, coordinators, departmental program administrators, and other support personnel engaged in conducting and facilitating clinical research.

The scope and function of this office will be to streamline, standardize, and coordinate the numerous activities that must take place prior to the enrollment of the first participant in a clinical research study.

The objective of the CRIS office will be to ensure that UM PI's and Administration are adequately informed prior to the initiation of clinical research studies. To enable a full administrative review of the implications of conducting a study, CRIS will assemble information enabling Administration to determine if projects are financially feasible.

This office will be sufficiently staffed so that the CRP is supported with efficient, effective, and responsive service. It is essential that CRIS provide high-value services that ease and expedite the administrative responsibilities of initiating clinical research studies. This must be done with an awareness of financial risks, operational challenges, and compliance expectations.

The scope of services provided by this office includes the following:

• Central intake, processing/routing of the application packet for all clinical research studies
• Coverage analysis
• Budget development, review and associated financial analyses
• Access to the research Charge Description Master(s)
• Contract review
• Contract negotiation including the establishment, as appropriate, of Master Agreements
• Educational development of appropriate members within the Clinical Research Program. The CRP, or "research community", includes Principal Investigators, research nurses, clinical research coordinators, department program administrators, data analysts, billing analysts, etc.)
• Manage infrastructure for organizing initiation records

1. Coverage analysis database
2. Budget database
3. Central regulatory files

• Assistance with Confidentiality Disclosure Agreements and preparatory support for approved study documents for submission to the IRB
• Operate as the primary administrative exchange with research affiliates
• Ensure that all necessary clinical research information is shared with the appropriate "downstream" departments and offices. Assemble, coordinate, and facilitate communications with necessary "customers" and "assistants" of the CRIS office. These may include:

1.IRB
2.Sponsored Programs
3.Contracts Committee
4.Research Integrity Office
5.Affiliated hospitals and clinics where clinical research is performed
6.Departmental personnel
7.University compliance officials

Clinical Research Revenue Cycle ("CRRC") and those managing clinical research billing, identifications of patients within billing systems, and other revenue cycle function

The out-of-scope services that shall be administered elsewhere within the CRP enterprise. These include but are not limited to the following:

• Submission to the Institutional Review Board or similar review committees
• Enrollment of a research participant (i.e., informed consent) or scheduling of a subject for enrollment
• Coordination of the clinical research revenue cycle
• Auditing
• Post-award management (e.g., award set-up, account set-up, assisting coordination of external site visits, etc.)
• Management of patient files and/or any other records associated with specific study participants, which are managed by research coordinators and affiliates
• Clinical research billing
• Core functions of the CRP (e.g., subject recruitment, research IT, bio-stats, experimental design support, protocol development)
• Clinical and Translational Science Award management
• Study conduct
• Research compliance functions
• Training coordination. (NOTE: CRIS personnel may support and assist but coordination should rest elsewhere)
• Research IT
• Proactive business development of clinical research opportunities

The primary operational functions of this office will be to 1.) Ensure that UM has an appropriate understanding of its cost structure as it relates to its CRP, 2.) Provide improved information to assist in more effective negotiations with sponsors, 3.) Prepare accurate coverage analyses such that UM can bill appropriately, effectively, and compliantly for clinical research tests and procedures and 4.) Establish administrative linkages with research affiliates and other sites.

Coverage analysis

• Develop coverage grids
• Review protocol schema and Clinical Trial Agreements for study details
• Determine whether a study is a National Coverage Decisions (NCD) "qualifying clinical trial"
• Provide information and training to research nurses / coordinators enabling them to assign encounters to the appropriate category (bill to sponsor, bill to payer, no bill sent)
• Maintain a "library"; of information on standards of care, NCD, Local Coverage Determinations, community standards, and other independent medical journals
• Analyses performed using the most current policies and guidelines of the Centers for Medicare & Medicaid Services
• Communicate relevant details of the completed coverage review with CRIS's contracting specialists so that they are able to better negotiate financial responsibilities during the contracting process
• Communicate relevant details of the completed coverage review with CRIS's budget analysts so that they are able to build budgets and ascertain the financial responsibilities of the sponsor, a patient's insurance, and the originating department
• Submit completed coverage analyses/reviews to a queryable database where other relevant members of the CRP can access information about a study
• Seek advice from outside experts or consultants as may be necessary to determine whether procedure is standard or care or research

Budget support and preparation

• Create and maintain cost documentation of the UMMG research Charge Description Master and manage coordination with research affiliate CDMs
• Develop and maintain templates and worksheets on the CRIS web page
• Review all preliminary budgets submitted by research teams for consistency with cost principles and inclusion of all costs for research tests and procedures, facilities and administrative costs (indirect and/or overhead costs). It shall be mandatory that all studies have a budget that is shared with the CRIS for review
• Coordinate budget development activities with PIs and study coordinators in accordance with the financial terms of the executed contract negotiated by CRIS's contracting personnel and the study sponsor
• Flag all ancillary services that will be leveraged in a trial and ensure that agreements on pricing are documented and that all service cores/centers are informed about upcoming research projects
• Document anticipated pro forma profits and losses on a per-subject and per-study basis

Contract review and negotiation for all sponsored clinical research grants and contracts

• Establish payment terms (e.g., timing, where to send checks, to whom checks are sent )
• Lead discussions with sponsors about who is accountable for paying specific tests and procedures described within the study's protocol (derived from Coverage Analysis)
• Work within the parameters of master or model agreement when they may exist
• Assist in negotiations with sponsors of facilities and administrative costs (Indirect or overhead costs) and other payment terms
• Review that all items in a CRIS-maintained checklist are addressed within a contract
• Execute under Board of Trustees authority contracts

Regulatory support

• Ensure that there is consistency between the contract and the financial disclosure language contained in informed consent documents ("ICF") sent to the IRB
• Assemble and manage the submission of CRIS-approved documents, along with Conflict of Interest Disclosures to the IRB
• Manage the rapid review and execution of Confidentiality Disclosure / Non-disclosure Agreements