Research Start-up and Maintenance Costs

The sponsor pays the institution a non-refundable administrative start-up fee. This covers the cost of preparing and submitting regulatory documents / required documentation to the IRB. This fee is not contingent upon receiving IRB approval and is due upon receipt of an invoice.  

This fee includes review of protocol and staff assignment for all research studies conducted at the CRC. It includes space and access to fax/copier internet for all monitoring visits.

*The CRC pharmacy study fees shall be determined before final budgets are agreed upon.

**A separate fee will be assessed if sponsor alters protocol that increases pharmacist involvement after the final budget.                                

The sponsor pays for local IRB review of all regulatory documents. This is payable upon review and not contingent upon approval. It includes an initial review fee and any subsequent continuing review fees.

If the study is conducted in locations outside UB practice and institutional facilities, additional fees may be added on study initiation. These include standard fees charged by Erie County Medical Center and the Kaleida Health system.

The sponsor pays for the billing grid, which helps determine the party responsible for paying the clinical services costs provided to human participants enrolled in the studies.

This fee also covers the cost of setting up and maintaining the trial in the CTMS. 

The institution pays a one-time lab set-up fee upon receipt of a correct and itemized invoice.

The sponsor covers additional training costs for the study coordinator and principal investigator if the sponsor requires training beyond that included in the site initiation visit and investigator meeting. The additional costs are based on an hourly rate and include time spent at webinars or in training on devices or equipment.

The sponsor pays the institution per IND Safety report received from sponsor and acknowledged by principal investigator. This fee also includes submitting documents to local IRB if applicable.  

Sponsor pays the institution for each completed SAE report. This reimburses the coordinator for his / her time spent gathering all SAE information. This fee may be adjusted depending on the complexity of the study.

The sponsor pays the institution for each annual review and/or amendment to the protocol or investigator brochure including revisions to the informed consent.

• Institution receives fees for site monitor visits. 
• Sponsor pays for preparation of scheduled sessions. This includes copying, faxing, emails, conference calls and addressing outstanding items that originate from the session. 

• The institution receives a fee for the FDA not-for-cause regulatory audit.
• The institution receives a fee for sponsor audit.
• These are based on hourly rates upon receipt of correct and itemized invoices from the institution.

The sponsor reimburses the institution for dry ice upon receipt of a correct and itemized invoice, not to exceed $1,000.

CRO defines an unscheduled visit as a subject visit which is not expressly set forth in the protocol, but is otherwise required for the study. Unscheduled visits are reimbursed on a per procedure basis in accordance with the rates set forth in the budget. 

In the event a medically necessary procedure is not included in the budget, the institution must receive prior written approval before procedure is performed. Amount of compensation for a procedure not included in budget will be approved at the time written approval is provided. 

• Institution receives a fee for each mid-study change of monitor.
• Institution receives a fee for each mid-study change of CRO. Payment is due within 30 days upon receipt of correct and itemized invoice from institution.

The sponsor pays a close-out fee upon completion of all study related procedures, including resolution of all queries and notification from the IRB of study closure.

The sponsor pays storage fees for study documents for the duration of required storage as stated in the contract. These fees are inclusive of all items charged to the study site for preparation and storage of study documents.

Once the study has ended and the IRB has been notified of study closure, the sponsor is billed for all documents to be sent to storage. If in the future, the sponsor requests documents from storage, such as for an audit, sponsor will pay the incurred fees.