ESSENTIAL SERVICES
COMPANION SERVICES
Other Site Fees for Clinical Research
- Review of fees
Find the Current Clinical Research Rates
If you are developing a clinical research budget, log into the Budget Resources page for up-to-date fee schedules.
Activating and conducting a clinical research study requires the review, approval and expertise of multiple teams and ancillary service departments within Indiana University, IU Health, and other affiliated health systems.
Fees for these reviews and services will be incorporated into the industry-funded study budget by the Principal Investigator’s department budget contact. Below we have provided detail on some of the most common ancillary service and review fees that may be applicable depending upon the study design.
Many of these fees are non-negotiable and must be paid by the investigator. Therefore, all costs related to the start-up and management of industry-funded studies will be passed-through to the Sponsor.
Required Pass Through Costs
These costs may include but are not limited to the following:
Research projects involving human subjects that are sponsored by industry or other for-profit companies are assessed a fee for IU IRB and/or Human Research Protection Program (HRPP) review. View the current IU IRB rates.
The Indiana CTSI Clinical Research Centers (CRCs) provide high-quality, competitively priced clinical research services and facilities for Federal and Industry-funded Indiana CTSI investigators, including clinic space, skilled nursing staff, lab & nutrition services for both inpatient or outpatient adult or pediatric visits.
The Investigational Drug Services (IDS) is part of the Indiana University Health Pharmacy Department. The IDS specializes in investigational drug studies and coordinates studies for both inpatient and outpatient protocols at IU Health University Hospital, Riley Hospital for Children at IU Health, and IU Health Methodist Hospital, and IU Simon Cancer Center.
The Office for Research Imaging is a joint effort between the IU School of Medicine’s Department of Radiology and Imaging Sciences and the experts at the Indiana Institute for Biomedical Imaging Sciences. The office is dedicated to supporting IU School of Medicine investigators and their staff through the use of biomedical imaging in research and clinical trials. The office successfully plans and implements complex imaging protocols within the vast resources offered between the IU Health and IU School of Medicine centers and vast hospital network.
The Clinical and Translational Support Laboratory (CTSL) provides SOP-driven, protocol specific processing and shipping services for studies collecting human derived research specimens. The highest levels of quality and consistency are assured due to their voluntary compliance to GCPs and GLPs along with independent QA oversight.
Additional Department Study Management Fees
These fees may include but are not limited to the following:
The non-refundable Department Administrative Startup Fee is inclusive of overhead and covers study startup activities performed by the Principal Investigator and their department/division staff prior to study activation.
Including but not limited to ongoing study management, teleconferences, study specific staff meetings, financial management, ongoing regulatory maintenance, creation/revision of source worksheets, receipt and ongoing inventory study supplies, etc.
Represents the time and effort to gain access, learn and utilize the sponsor required document management and/or finance portals.
Represents staff time and effort to modify or renegotiate study budget, route amended CTA/Budget to the OCR contracts and submit revised documents to the OCR Financial Compliance team.
For the preparation of all documents required for submission of the amendment to the IRB for review and approval.
For the preparation of all documents required for submission of the annual continuing review to the IRB for review and approval.
To be paid upon close-out fee upon completion of all study related procedures, including resolution of all queries and notification from the IRB of study closure.
May increase depending on size & length of study; or retention requirements
This includes coordinator time, PI time and room charge
(Per hour charge)
Accounts for the time and effort of staff to pull documents from patient binders, scan, redact and sit on calls with the monitors.
(Fee assessed for each study monitor change)
Accounts for the additional staff effort required to familiarize the new monitor with our medical records system/study charts, and our site’s policies, procedures, and various departments
Defined as queries asked and answered more than twice; EDC glitch/dysfunction; queries after archiving
(Per report)
Includes time and effort by staff and PI to review each report, determine if reportable and obtain appropriate signature
Includes the time and effort for the coordinator to complete the initial report; obtain and review medical records for follow up reporting. PI time and effort to review all records and reports prior to signature and submission.
(Due to sponsor amendment or change in ICF)
For staff effort to familiarize patient with consent changes, answer any questions, and document the re-consent process.
For the preparation of all documents required for submission of the amendment to the IRB for review and approval.
For the preparation of all documents required for submission of the annual continuing review to the IRB for review and approval.
To be paid upon close-out fee upon completion of all study related procedures, including resolution of all queries and notification from the IRB of study closure.
May increase depending on size & length of study; or retention requirements
This includes coordinator time, PI time and room charge
(Per hour charge)
Accounts for the time and effort of staff to pull documents from patient binders, scan, redact and sit on calls with the monitors.
(Fee assessed for each study monitor change)
Accounts for the additional staff effort required to familiarize the new monitor with our medical records system/study charts, and our site’s policies, procedures, and various departments
Defined as queries asked and answered more than twice; EDC glitch/dysfunction; queries after archiving
(Per report)
Includes time and effort by staff and PI to review each report, determine if reportable and obtain appropriate signature
Includes the time and effort for the coordinator to complete the initial report; obtain and review medical records for follow up reporting. PI time and effort to review all records and reports prior to signature and submission.
Includes time spent reviewing charts, time to go hand out flyers at events, etc. Fee will be determined by complexity of inclusion/exclusion criteria.
If study drug is maintained by PI/study team outside of IDS. Covers Initial receipt of drug, storage set-up, temperature monitoring set-up, Pharmacy Log creation, etc.
If study drug is maintained by PI/study team outside of IDS. Covers file Maintenance, Accountability Records, Ordering, Inventory, Temperature Monitoring, Storage Space, Drug Destruction, etc.
One-time fee for audit, which includes staff time for preparation (pulling and organizing documents), space for multiple days, etc. Additionally, the hourly fees noted below for coordinator/PI effort will be billed for time spent during the audit to meet with the audit team, answer questions and discuss findings. Please note: Sponsor audit in preparation for FDA audit would require 2 separate audit fees.
Billed for attendance at investigator meetings, audit meetings, and other unanticipated needs beyond monthly oversight.
Billed for attendance at investigator meetings, audit meetings, and other unanticipated needs beyond monthly study management.