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Definitions

Budget Workbook

Electronic tool used by OCTR in conjunction with study team to identify, segregate and monitor charges

Clinical Research

  1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes:
  • Mechanisms of human disease
  • Therapeutic interventions
  • Clinical trials
  • Development of new technologies
  1. Epidemiologic and behavioral studies.
  2. Outcomes research and health services research.

Clinical Trial

A clinical trial is a systematic, organized, prospective intervention study in human subjects that is conducted according to a formal study plan (protocol) and that has measurable efficacy and/or safety-related outcomes that are amenable to statistical analysis. It employs one or more intervention technique(s) including prophylactic, screening, diagnostic, or therapeutic agents, devices, or procedures. It must have approval of the IRB or review with a determination of exemption. Clinical trials are distinguished from other types of clinical research (e.g., behavioral research) that may need IRB approval but do not meet the other criteria of clinical trials.

Clinical Trials BEAN Initiation Form

The form generated by OCTR at trial startup to request from UMG a BEAN unique to this trial

Clinical Trials Initiation Form

Upon IRB approval, the form generated by OCTR used to notify all departments involved of the services to be charged to the trial. This form includes critical billing information such as: BANNER account number, BEAN number, party responsible for TES audits and HOLD BILLS (if applicable), name of recipient of Transfer Vouchers list of services to be charged, and category of sponsor

Notification of Research Patient Admission Form

Form used to notify Director of Finance and Patient Access of Protocol Induced Costs (PIC) for in-patient research charges

Preliminary Budget Information Packet

OCTR document that initiates the Budget Workbook process. Packet is emailed to PI/Study Coordinator in response to query regarding doing a Budget Workbook; it is completed by the study team and returned to OCTR via email prior to study team meeting with OCTR staff

Protocol Induced Costs (PIC)

Items and services that are specifically excluded from the definition of Routine Clinical Services in a qualifying clinical trial such as:

  • The investigational item or service itself
  • Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient
  • Items and services customarily provided by the research free of charge for any enrollee in the trial
  • Items and services provided solely to determine trial eligibility

Qualifying Clinical Trial

As per the Medicare National Coverage Determination (“Routine Costs in Clinical Trials, also known as the CMS Clinical Trial Policy or “CMS CTP”): Any clinical trial receiving Medicare coverage of routine costs must meet both the basic three requirements and seven desirable characteristics to qualify for coverage. “Deemed” studies automatically meet the criteria for the seven desirable characteristics.

Research Labels

Labels showing a backward “ᴙ” generated by the IDX scheduler when research visits are scheduled. Research labels are used to designate “research subject” vouchers and indicate PIC costs.

Research Patient Enrollment Sheet

Form generated by the study coordinator and emailed to OCTR to notify OCTR that an individual has been enrolled in a trial. The Research Patient Enrollment Sheet includes the unique case number assigned to the study subject .OCTR forwards the sheet to: Institutional IDX scheduler (trials other than CRC), UMG Billing, JDH Billing Designee, Research Pharmacist (if indicated) and Patient Access Designee. The form communicates study subject’s unique Patient Case number used to charge specific and exclusive Protocol Induced Costs.

Routine Clinical Services (RC)

Routine costs of a clinical trial include all items and services that otherwise would be generally available to Medicare beneficiaries regardless of whether they are assigned to the experimental or control arm of a qualifying clinical trial. “Generally available” means that the item or service falls within an existing Medicare benefit category that is not excluded from coverage by another provision in the law and that is not the subject of an NCD stating that the item or service is not covered. If an item is covered outside of a clinical trial it is covered within the clinical trial.

Study

In this context, synomous with clinical trial/clinical research