Getting Started (draft)

OCTR Process Overview: Understanding the Overall Process of the OCTR

Budget Process: Determination Schema for Industry Sponsored, Industry Supported, University to University, Co-operative Group or Foundation Supported Clinical Trials

A. PRE-TRIAL:

• • In order to open a clinical trial at the University of Connecticut Health Center, the following question must be answered to determine the proposal’s flow through the institution:
    • Does the project involve human subjects?
  • All studies require a prelim packet so a budget and memo can be provided to the study team. At this time, the Budget & Financial Specialist will determine if the study only requires an expedited memo – this is required for IRB submission.

B. BUDGET WORKBOOK:

• OCTR staff complete the Budget Workbook once the prelim packet is received from the study team:
  • Items and services are delineated as Protocol Induced Costs (PIC) or Routine Clinical Care (RC)
  • T&E is designated for dedicated research staff
• Once the PI receives, reviews, and approves the budget workbook they provide the Budget & Financial Specialist with the approval to proceed with negotiations.
• Budget & Financial Specialist commences budget negotiations and/or PI provides additional funding sources.

C. INITIATION OF ROUTING:

• Upon OCTR completion of full contract negotiations (budget and contract), the PI approves the budget and signs the Internal Proposal Review Form (IPR), thereby initiating the routing process. Routing sheet is then signed by:
  • PI’s Department Chair
  • Co-Investigator (if applicable)
  • Co-Investigator’s Department chair
  • Dean
  • Director, Sponsored Program Services

D. CONTRACT

Contract negotiations continue in parallel with the budget preparation and the routing, as shown on the preceding flow chart above.

• Contract negotiations may be ongoing at the time of initial IRB submission.

E. IRB FINAL PROCESS

• Study team may now submit a complete final application packet to the IRB per institutional guidelines, with the memo certifying that a Budget Workbook is complete from Budget & Financial Specialist and the fully executed agreement from the Contract Specialist.

F. POST-IRB APPROVAL PROCESS

• Study cannot open until there is a fully executed contract and final IRB approval.
• Upon final IRB approval, Budget & Financial Specialist will reach out to schedule the budget initiation meeting.
• Budget initiation meeting occurs.
• PI signed document received by OCTR.
• Study Opens

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 the approval of the IRB or the IRB’s 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 Initiation Form

Upon IRB approval, this form is generated by OCTR  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,  party responsible for EPIC Research Billing Review, name of recipient of Transfer Vouchers, list of services to be charged, and category of sponsor.

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.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R74NCD.pdf

“Deemed” studies automatically meet the criteria for the seven desirable characteristics.

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