Industry-sponsored clinical trials are research projects where the sponsor provides the PI with protocol. Research and Development provides a Clinical Trials Start-Up Handbook to assist principal investigators (PI).
The follow describes the typical pre-award procedures required to initiate a new clinical trial:
- Confidentiality Agreement (CDA) or Non-Disclosure Agreement (NDA)
Before the sponsor will share the protocol with the PI, a CDA or NDA must be signed between the two parties. This is a legally binding document. A CDA or NDA requires an institutional signature and therefore must be routed through R&D for review and approval prior to signature.
- Feasibility Decision Meeting
Once the PI decides to pursue the clinical trial, R&D will schedule a Feasibility Decision Meeting all stakeholders involved in the proposed study (i.e. imagining, laboratory, TSG, etc). The purpose of this meeting is to ensure an informed decision is made as to whether or not the investigator, department and institution are prepared to pursue the projects. Prior to the meeting, the Principal Investigator must complete the Clinical Trial Application Form and the Service Request Form, if applicable.
- Contracting: Clinical Trial Agreement
With the receipt of the Clinical Trial Application Form, R&D will initiate the contract review and approval process with Carilion's legal team. The PI must also provide R&D a copy of the study protocol, budget proposal and informed consent, if available.
- Budget, Billing Grid & Clinical Conductor
The R&D will work directly with the PI and his study team to ensure an appropriate budget is developed. The PI will need to identify all the procedures in the protocol as either standard of care or research related. The billing grid identifies all services that must be built in EPIC to be charged to the research account. In addition to billable services, the budget must include salary support for coordinator or other support staff, overhead, pass through costs and invoiced items. All clinical trials must including a 30% overhead fee per institutional policy. Once the budget is complete, R&D will build the budget in the internal clinical trial management system called Clinical Conductor.
- EPIC Build
Research studies that have clinical procedures that are paid for by the sponsor (not the patient's personal/family account) need to be set up in EPIC. TSG's EPIC team will work with the PI and the study through a series of meetings to develop the necessary elements to proper filter research charges. R&D will engage TSG in the process once the billing grid is complete.
For more information please see Clinical Research Billing Compliance Manual.
- Institutional Review Board (IRB)
Please see Carilion Clinic's IRB section for guidance on IRB submission and approval.