105 CTRU Billing Procedures

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) describes CTRU interactions with the Sponsor or Contract Research Organization (CRO). This procedure is intended to meet Food & Drug Administration (FDA) federal regulations and Good Clinical Practices (GCP) for billing procedures for services provided to PIs and Sponsors.

Internally Funded Project: Projects with internal funding sources – including but not limited to, start-up funding, and bridge funding.

Externally Funded Project: Projects with external funding sources – including but not limited to, federal funding, pharmaceutical funding, and philanthropic funding.

NURSING: Completes minimal to high intensity study procedures and data collection or medication administration with research participants.

PROJECT MANAGEMENT: Oversees and coordinates the operational (i.e. IRB, feasibility, budget, etc.) aspects of assigned functional areas for clinical studies and works closely with study team and Principal Investigator.

RESEARCH ASSISTANT: Completes study related activities (i.e. may complete prescreening, informed consent, data collection/entry, recruitment, scheduling and participant compensation) as delegated by the PI.

RECRUITMENT: Encompasses the study specific creation, management, and execution of subject recruitment and marketing strategies.

STUDY PHYSICIAN: Provides protection of research participant safety through administrative review (i.e. study protocol development, adverse and serious adverse event management, lab or imaging results interpretation) or procedural oversight of a research study. May perform protocol specific medical procedures.

START-UP/CLOSEOUT Fee: A one-time fee charged assessed to cover the administrative and regulatory activities required to prepare a study for activation and closure.

• Time spent on direct project activities will be tracked as a BILLABLE service.
  • Examples of direct project activities include pre-screening, scheduling, recruitment, data or IRB management, monitoring visits, and conducting study visits.

• Time spent on supportive activities will be tracked as a NON-BILLABLE service.
  • Examples of supportive activities include visit preparation, clean up, equipment calibration, consultation services, and general study communication

4. Externally Funded Project Time Tracking:

• All time spent on necessary project activities should be tracked as BILLABLE, unless otherwise directed.