Following are the procedures for the use of a clinical trial* operating account (also referred to as a pooled account or combined account) in the administration of industry-funded or industry-sponsored clinical trials. Utilizing the clinical trial operating account allows research units/areas an option to source salary and operating expenses to one account and move the salary and operating expenses to the appropriate grant account no less frequently than on a quarterly (March, June, September, and December) basis.

The UAB Effort Reporting Procedures requires UAB Project Employees to apply effort to industry-funded or industry-sponsored clinical trials for work performed on the trial. The manner in which this is reflected on the UAB Project Employee’s effort report depends upon whether the industry-funded or industry-sponsored clinical trial is assigned to:

  • an investigator or staff clinical trial operating account or
  • individual industry clinical trials account(s).

*For the purpose of these procedures, an industry-funded or industry-sponsored clinical trial is any research project that fits the UAB Clinical Trial definition as well as research projects in epidemiology, physiology, health services, education, and outcomes.

Operating Account Information and Attributes

  • The account will have effort reporting attributes.
  • All revenue from clinical trials, including start-up fees, must be deposited into the appropriate Grant Account (GA); this includes pending accounts. Revenue is never deposited into the clinical trial operating account; expenses are always moved off the clinical trial operating account and placed on the appropriate GA or GL.
  • All direct costs/expenses related to the clinical trial (i.e. study start-up expenses, hospital bills, study specific lab supplies, participant stipends, etc.) must be paid directly from the appropriate grant account.
  • The clinical trial operating account will run in a deficit every month due to the monthly salary and operating expenses; however, the account must be “zeroed” out no less frequently than on a quarterly (March, June, September, and December) basis by moving the expenses to the proper grant accounts or general ledger accounts. Monthly clearing of the account for staff salary and operating expenses is recommended to ensure accurate effort reporting. Refer to “Management of Investigator Salary” below for more information.
  • Research units must have a clear understanding of the monthly expenses placed on the clinical trial operating account and be able to provide justification for expenses allocated to the account. A research unit should know what it costs to run their research unit/area every month (i.e., staff & faculty salary and operating expenses).
  • Research units must practice good financial management that includes reconciling and reviewing the accounts monthly. Moving expenses on a quarterly basis does not eliminate the responsibility to monitor and reconcile accounts on a monthly basis or the need to move expenses on a more frequent basis in order to reconcile, close and report on grant awards ending at different periods.
  • Should expenditures become uncollectible due to a delay in processing documents (after the close of the grant and final reporting), that amount will be charged to the department’s VCS account.
  • Appropriate forms for the fiscal management of a clinical trial account:

Management of Staff Salary

All staff salary must be sourced directly to the clinical trial operating account.

  • Staff salary must be reclassed no less frequently than monthly from the clinical trial operating account to the appropriate grant accounts based on effort expended on each clinical trial (a tool is provided below). The department is to maintain supporting source records within the department related to individual effort allocated to each industry clinical trial.
  • Reclassess for the months ending March and September must be done prior to the generation of effort reports approximately 15 days after the end of the reporting period.
  • Do not use a Cost Transfer Form (CTF) to move staff salary. Salary must be moved using a salary reclass form in Oracle.
  • Staff salary that is not associated with a specific clinical trial must be moved to the appropriate GL account no less frequently than quarterly. Unfunded salary cannot reside on the operating account.
  • Departmental Effort Officers (DEOs) must review the effort reports and hold until all salary has cleared the operating account for that reporting period.

Management of Investigator Salary

  • The operating account can be used for investigator salary. The research activity performed in aggregate can be sourced to the operating account for work performed on several studies.
  • The faculty salary sourced to the operating account will be moved via a cost transfer at a minimum quarterly (March, June, September, and December) using internal cost recovery code 8709599. The department is to maintain supporting source records within the department related to individual cost allocated to each industry clinical trial.
  • The investigator’s effort report will list the operating account number (i.e., GL) and reflect the effort expended on the clinical trials in aggregate for that reporting period.

Management of Operating Costs

Operating expenses (i.e. desk phones, network charges, office supplies, etc.) for a research unit can be charged to the clinical trial operating account or can be directly charged to the applicable study account at the time the expense is incurred. For the former, please see below example of a Detail Transaction Report from Oracle. The clinical study site should print this monthly for the GL account. Operating expenses that are positive items (i.e. debits to the account) are “circled” under the Actual column on the report. Items that cannot be charged back to GA accounts (i.e. pagers, lab coats, etc.) must be sourced directly to an appropriate GL account.

  • Operating expenses will be transferred from the clinical trial operating account back to each grant account no less frequently than quarterly. A CTF will be used to complete the transfer. An Excel spreadsheet is provided as a tool to assist in distributing the funds based on object codes (see attachment). If you have further questions, please ask your grant accountant.
  • The CTF must be accompanied by a detailed transaction report of the clinical trial operating account and the Excel tool/spreadsheet detailing the expenses by object code and the grant accounts charged.
  • A GL account must be used for expenses that are not allowed on an operating account (e.g. pagers, lab coats).