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 Start-Up Fee $10000 This fee includes completion of the feasibility processes (i.e. questionnaires, protocol review, study meetings), administrative start-up procedures (including contract negotiation, budget negotiations, IRB documents preparation and submission(s) to IRB of record), and other activities including but not limited to, based on study, required protocol/IT system/equipment systems trainings, PI time to implement study, and creation and build of the study in CTMS, and the financial and administrative close out activities. Lead PI Study Fee $5000 When the NJH PI is the study wide PI, and there is no separate individual agreement between the PI and Sponsor, this fee covers PI time and effort related to input on study design and protocol development. Archive $1500 This fee covers the 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/Sponsor/study requirements. IRB Local Context Review $1333 This fee is applied for studies using an external/commercial IRB. This fee is charged to the study by the NJH Human Research Protection Program (HRPP). Study Team Rates Role Amount Investigator $333 / hour Clinical Research Coordinator $133 / hour Research RN $166 / hour Invoiceable Fees These fees are included in the budget and are invoiced per occurrence. Name Amount Description Monitor Visits $333/day Dedicated space, resources, and study team member(s) 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). Audit – Sponsor $1000/day Dedicated space and resources to conduct the audit. Dedicated study team member to be available during the length of the visit. Audit – FDA, Routine $2000/day Dedicated space and resources to conduct the audit. Dedicated study team member(s) and dedicated FDA Inspection coordinator who will be with the Inspector for the length of the visit. Additional Fees Additional study specific fees will be included in the budget, when applicable. Name Amount Description Laboratory Fee $500 Set-up and preparation, study-specific lab requisitioning. Preparing for and ensuring study specific sample processing. Pharmacy Start-Up Fee $2000 Protocol and IB review, review of Pharmacy MOP, space for drug storage, dispensing procedures and staff training. Radiology Review Fee $1000 Review of protocol and imaging manual. Includes study start-up by Radiology, study-specific requisitioning, maintenance, and close-out. Additional fees may be required for studies that require more complex imaging requirements or lengthy training sessions. Protocol Amendment Fee $1000 Study amendments requiring changes to the contract and/or budget. Includes time by PI, study team, and budget and contract staff to review and implement changes. Re-Consenting Fee $133 Re-consenting subject due to an amendment in the study. Safety Reports $400 Per 50 completed IND Safety Reports after initial 50. First 50 have no fee associated with them. Adverse Events Invoice Investigator and Coordinator time to review and report AE/SAEs. Time requirements will vary based on internal versus external reports. ClinCard Set-up Fee $10.33 / participant When compensation to study participants is managed by Institution, fee included for time and expense related to distribution and set up of a reusable debit card for each participant. Pre-screening and Chart Review Fee $266 / month Time spent reviewing participant charts for recruitment and regular review of inpatient and clinic patients for inclusion in the study. Assessed beginning at site activation date to closure of study enrollment. Equipment Management $110 When Sponsor provides required equipment for a study, fee covers inspection and certification by NJH Biomedical Engineering. Fee is per machine and per inspection (if required more than once). Annual and Recurring Fees These fees are required for Industry Sponsored clinical trials and are 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 $1000 Continuing regulatory and administrative maintenance of the study. Covers preparation of continuing reviews, modifications to the study, CTMS record upkeep, IT systems maintenance, upkeep and revision to regulatory documents. Study Coordinator Maintenance $1000-$5000 Upkeep of study trial master file and source documents, revising source documents, accessing and printing from electronic portals, time on conference calls, time spent pre-screening subjects and undergoing any specialized study training. Amount is dependent on phase and complexity of study, and staffing required (i.e. RN involvement). 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 uniformly to all Industry sponsored studies. 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 to per visit total cost.