TERMS AND PROCESSES WE USE:

Principal Investigator (PI). The PI is usually a physician or PhD, and is the main research scientist to whom the responsibility for the oversight and scientific integrity of a grant or study is entrusted.

Study Coordinator (SC). The key staff linkage between the protocol, the PI, and the institution. The person organizing the flow of patients into a study, preparing all the Case Report Forms, managing the work flow involved, making sure each patient follows the specific study protocol and procedures required, receiving invoices
and preparing them for submission to get paid, and monitoring overall progress of the study. There are usually one or more assigned to each study.

Institutional Review Office. The Institutional Review Office (IRO or IRB) is a formal department within SRC which evaluates the ethics and safety of every research study or trial which involves human subjects. No study will occur at SHS unless and until the Institutional Review Board (IRB) has done an Initial Review (and ongoing Continuing Review) and approval of the proposed study’s process, procedures, protocol and wording of Informed Consents. Federal grants are
reviewed directly by our internal IRO. Commercial studies are generally reviewed by Western IRB (WIRB), while being monitored under contract with our IRO.

How a Study Starts:

Project Initiation
A Study Coordinator initiates the process by completing a Protocol or Project Initiation Form (PIF). This triggers SRC administration to set up a specific CRC Administrative File and Study Number, which is a unique identifier that will remain with the study throughout it’s history within the institution. If the study is being conducted with our Study Manager (SM) software program, administration also enters the "shell" for the study into the software.

(and) Contract Negotiation
The Study Coordinator initiates a study-related budget, and works with the PI and department manager to review the cost-feasibility of a study. The manager enters into contract negotiations with the sponsor to ensure that all costs are met and that contract language is appropriate for the institution. Contracts must include institutional protections such as Indemnification and coverage for Study-Related Injury. The contract is then signed and/or the grant is awarded.

(and) IRB Application
At the same time, the Principal Investigator and/or the
Study Coordinator, through the assistance of the Regulatory Affairs Coordinator, initiates an Application to the IRB or WIRB for approval of the Investigator, the Informed Consent, and the Protocol to ensure adequacy of human subject protections.

(and) Internal Budget
Using the negotiated sponsor’s contract budget and either our SM Budgeting or the Budget Builder Template, the administration office then prepares an overall Internal Budget for the study which translates staff time, visits, procedures and other Patient costs into composite study totals within the hospital’s Chart of Accounts.

(and) Project ID
At this time, the Grant and Contract Analyst (GCA) assigns a unique Cost Center Project ID number to the study. The budget is signed by the PI and the Research Departmental Manager, and is placed in the Study File. A Project Setup Fee of $3,000 is also billed to the sponsor at this time.

Patients cannot be enrolled and the Study cannot begin until all of the above steps are completed and fully approved.
 

Setup Costs Bid and Proposal (B&P). When Swedish is considering whether or not to do a study, and is in the process of reviewing a protocol, budgeting and preparing for the study, and finalizing the contract, all coordinator staff time is charged to a special “Bid and Proposal” cost center in the department. If a study is initiated, a “Setup Fee” of $3,000 is billed to the sponsor, and when it is paid the funds are placed into the new cost center established for the study. Soon after that, the staff hours that had been booked to B&P are re-classified into the cost center, with the funds from the setup fee being used to pay them. Costs for studies that are never implemented remain in the B&P cost center and are charged against indirect cost funds in the department (see Indirect Cost, below).

CRC File.  A series of four fields which label a study. The first field is the general area of study, for example, CVR for cardiovascular, TI for oncology. The second field is four letters designating the PI, for example REIM for Dr. Mark Reisman (the first 3 letters of the last name and the first letter of the first name). The third field is the source of the funding. The first letter designates whether it is F-ederal, C-ommercial, N-on Profit; the remaining three letters designate the source, such as FNIH for National Institutes of Health, CBAY for  Bayer, or CELI for Eli Lilly. The final number is the unique file study identifier, and is often referred to as the “study number” or “project number”. This number begins with the two-digits designating the year first started, then two-three additional numbers to give it a unique (e.g. no other study has that number) identity in the system. So 0455, would be the fifty-fifth study started in the year 2004. A study keeps the same number throughout it’s life at SRC.
 

Project ID. This Project ID Number often gets confused with the “study or project number” defined above, but it is completely different. This is the Cost Center assigned to a given study. Similar to checking account, the name on the check could be seen as the study number, but the account number printed on the bottom of the check is the PROJECT ID. It is also unique in the system: no other study has that account number.
It is critical, when paying bills or reporting time and effort (T&E) labor hours on a study, that the correct Project ID is used, so as not to mistakenly inflate the costs on a different study and underepresent costs on the actual study in use.

Case Report Forms. Although they vary widely between sponsor and study, these CRF’s, whether paper or digital, are essentially the reports submitted to the sponsor for each study visit which document the clinical progress and response of each patient to each facet of the study protocol. They frequently are also the means by which sponsor reimbursement is triggered.

Chart of Accounts. The way in which all expenses are categorized, much the same way as in the home, such as food, food, rent, allowance, car, entertainment, utilities. Key research categories include salaries, benefits such as annual and sick leave, health insurance and retirement, as well as physician fees paid out of the study, lab costs, medical supplies, office supplies, pharmaceuticals, x-rays, travel costs, and miscellaneous expenses. Study costs are outlined in a budget which the Manager and the PI sign at the time the study is begun.

Study-Related Costs.  Any cost which is assigned to a study must be allowable, allocable, and reasonable. There are some costs which are prohibited by institutional and federal regulations. Costs can only be booked to a study in direct proportion to the portion they are used by that study in relation to other studies which may share those costs. Costs must meet “common sense” requirements of appropriateness, market value, and need for the item to perform the study.

Time and Effort (T & E).  Staff time is usually the most significant cost in a study. Under accounting standards and federal regulations, all study costs, including salaries, must be differentiated, or cost-allocated specifically to each study. At Swedish this is done through the use of a special computerized system online within SRC which allows all staff to report time to multiple cost centers and which translates these amounts of time into the institution’s payroll and accounting system.

Non-Standard Requisition (NSR) (Accounts Payable Check Request). Other than payroll, most other research bills consist of supplies, laboratory, pharmacy, physician, and radiology costs, as well as patient stipends.  The NSR is the "check request" or “transmittal” form which is used to request the hospital’s Accounts Payable (A/P) department to send a check. NSRs need to be coded with the Vendor Name (the person or business being paid) and Address, the Invoice Number, the Account Code, Project ID, and the Amount. NSRs are sent to the departmental manager for approval (signature) before submission to A/P.

MYSIS. Hospital physicians are paid based on a study-related monthly “Pro-Fee Log” signed by the physician which lists all physician services provided to a study subject under the protocol for which the study is paying the fee. These costs are then approved by the coordinator and manager and are coded into the MYSIS system which is the software used by the Swedish Professional Division to recognize physician and clinic earnings in each medical practice area operated by the hospital. The expense is recognized on the research and study side by a journal entry to the Project ID, made by Finance at the end of each month into the hospital’s accounting system (PeopleSoft).

Indirect Cost (F & A). This is the federally recognized “overhead” expense for corporate or institutional costs such as facilities, equipment, utilities, communications, central administration, and core central services such as accounting, human relations, information systems, finance, maintenance, and engineering. The current federally approved rate for Swedish is 55% of all allocable direct costs. This is added much the same as sales tax, each time a bill is paid.
Commercial sponsors are unwilling to pay the actual rate of 55%, hence the hospital covers the difference, or the loss, for commercial studies in consideration of the value received by the Institution in being a leading-edge research facility.

Pass-Through Costs. Costs which are not covered in the standard reimbursement by a sponsor, but which are “allowed” by virtue of contract negotiation prior to commencement, and for which the sponsor has agreed to pay additional monies, provided that we bill them separately for these costs. These often include IRB or advertising costs, specific lab or radiology tests, travel, or unique stipends to a
study subject. A critical factor is to note on the NSR that these are “pass-thru” or “invoiceable” costs, so that staff will also specially bill the sponsor for reimbursement. Many of these expenses are not subject to Indirect Cost.

Study Manager™ (SM).  Study Manager™ has been implemented at Swedish to provide a single integrated and secure multi-user management information system across all commercial study areas and departments within the Swedish Research Division. SM is used in order to monitor study enrollment, patient study visit progress, contractual earnings (accounts receivable), and the audit at study close to be sure that all bills for research-related non-Standard of Care services and procedures were paid by the research center and not billed to third party payers.

Digital Financial Summary (DFS). The DFS, a monthly profit and loss summary for each study, lists the budget, expense, cash payments, and balance of earnings receivable. The DFS shows the current operating balance of a study. If a study is showing significant losses, it may mean that CRF’s or special Invoices need to be sent in order to trigger a sponsor payment.

Affiliate Investigators. Physicians and other scientists who are not employed directly by the hospital but who conduct research utilizing Swedish services and resources under the auspices of a special contract through the Research Center. These studies, depending on the contract, either may or may not use SRC Study Coordinator personnel.