Institutional Fee Sheet Download HRPP SOPs Clinical Trials Find a Researcher Required Fees These fees are required for all Industry Sponsored clinical trials. They are non-negotiable and non- refundable. Name Amount Description New Study Administrative Start-Up Fee $12500 This fee includes completion of the feasibility processes (i.e. questionnaires, protocol review, study meetings), and start-up procedures (including contract negotiation, budget negotiations, IRB documents preparation and submission), and other activities including required study trainings, set-up and preparation of lab for study specific sample processing, creation and build of the study in CTMS, and the financial and administrative close out activities. Investigator Fee $2500 This fee includes PI time required for protocol review, feasibility determination, meetings with sponsor and start-up staff for site preparation, and other activities required by the protocol for start-up. Archive $1500 Long term storage (and retrieval) of study-related documents at a secure, off site, temperature controlled facility for the duration of time required by Federal regulations. Ancillary Reviews These fees are charged by departments outside the Clinical Research Unit. They are non-negotiable and non-refundable. IRB Local Context Review $2666 This fee is applied when a central IRB is the IRB of record. The cost covers the required submission to the NJH Human Research Protection Program (HRPP) for new study registration review, local context review and post-approval monitoring reviews. Coverage Analysis $2666 Completed for interventional, FDA regulated clinical trials that involve a mix of standard of care and research activities. Additionally, coverage analysis may be required in other situations (i.e. clinical procedures performed at affiliate hospitals). Budget Revisions – Coverage Analysis $266/hr. For studies with a coverage analysis, hourly rate when a budget revision requires updated coverage analysis. Radiology Review Fee $1000 Review of protocol and imaging manual. Includes study start-up by Radiology, study-specific training for Radiology team involved, initial phantom scan, requisitioning, maintenance, and close-out. Additional fees may be required for studies that require more complex imaging requirements, multiple phantom scans, or lengthy training sessions. Pharmacy Start- Up Fee $2000 Protocol and IB review, review of Pharmacy MOP, space for drug storage, dispensing procedures and staff training. Pharmacy Close-Out Fee $500 Drug Destruction or return and accountability Advertising Per study Advertising needs will be assessed on a case-by-case basis. NJH Marketing Department has the capability and resources to create and manage content via multiple mediums and across various social media platforms. Sponsor approval required before marketing campaign is initiated. IST Security Review $500 IST Security Review required when a study involves study participants using their own devices or Sponsor provided devices to track and collect data. Review of vendors and/or apps that will access National Jewish Health’s secure Information System Technology network or involve participant data being transferred between participant/site/sponsor/sponsor representatives. Study Team Rates Role Amount Investigator $333 / hr. Clinical Research Coordinator $133 / hr. Research RN $166 / hr. Invoiceable Fees These fees are included in the budget and are invoiced at each occurrence. Name Amount Description On Site Monitor Visits $500/day Dedicated space, resources, and study team member(s) time to prepare for and support monitoring visits. Time spent scheduling, coordinating, and working with the monitor over the course of the visit (time and effort not covered in per-participant budget). Remote Monitor Visits $133/hr. Coordinator time for remote monitoring visit as well as preparing/scanning/uploading documents. Audit – Sponsor and/or FDA $1000/day Dedicated space and resources to conduct the audit. Dedicated study team member to be available during the length of the visit. Additional Fees Additional study specific fees will be included in the budget, when applicable. Name Amount Description Protocol Amendment Fee $1000 Includes time by PI, study team, to review and implement changes including, but not limited to, re-training, regulatory revisions, revisions to source documents and changes to the Informed Consent document Contract/Budget Amendment Fee $1000 Includes time by finance and legal teams when study amendments require changes to the contract and/or budget. CRF Changes $133/hr. Coordinator time when changes to the CRF results in the need to re-enter data or collect historical information previously not required. Re-Consenting Fee $133 Re-consenting subject due to a study amendment or new information important to the participant becomes available. Safety Reports $35 Per completed IND Safety Report. Serious Adverse Events Invoice Investigator and Coordinator time to review and report SAEs. Time requirements will vary based on internal versus external reports. Pre-screening and Chart Review Fee $25-$50 / chart Time spent reviewing participant charts for recruitment and regular review of inpatient and clinic patients for inclusion in the study. Fee based on complexity of the inclusion/exclusion criteria. Annual and Recurring Fees These fees are required for Industry Sponsored clinical trials and are non-negotiable and non-refundable. These fees are collected regardless of site enrollment total. Fees are invoiced on an annual basis starting one year from contract execution. Name Amount Description Clinical Research Services Maintenance $2500 Administrative and study coordinator time and effort unrelated to study visits, including but not limited to: continuing regulatory and administrative maintenance, preparation of continuing reviews, modifications to the study, upkeep of (a) Institutional electronic record keeping systems (b) NJH IT systems maintenance, = (c) regulatory documents,. (d) investigator site master file, (e) revising source documents unrelated to protocol amendments, and working in Sponsor electronic portals (i.e. Shared Investigator Platform), lab kit maintenance, and ongoing sponsor/Institution communication management. Drug Storage and Maintenance Fee $500 Annual fee which accounts for facilities, inventory control and accountability, management for ordering investigational product, and systems and space used to store drug according to the protocol. Applicable for studies that involve investigational drug. NJH Institutional Overhead Overhead for Industry Sponsored clinical trials is 33.3%. This rate is non-negotiable and is applied to all Industry sponsored studies in the same way. All fees included on this fee sheet are inclusive of overhead. Market Increases For studies that continue beyond three years, a 3% market rate increase will be applied each year to per visit total cost starting on day one of year 4.