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| Event Description | Trigger Type | Comments | |||||
| Additional Monitor | CRA | ||||||
| Central Lab Processing | CRA | ||||||
| Fee for Additional Sponsor Initiated Investigator Meeting | CRA | Hotel, per day | |||||
| CRA | IND Safety Reports processing, each | CRA | Lodging | CRA | |||
| Mileage, per mile at current federal rate | CRA | Negotiated rate should remain $0.00. Subject sequence # and additional details should be documented in comments. | |||||
| Monitor Visits | CRA | ||||||
| Monitoring: Cancelation | CRA | ||||||
| Monitoring: Change in Monitoring Staff, per event | CRA | ||||||
| Monitoring: No Show, per event | CRA | ||||||
| Not for Cause FDA Audits | CRA | Reconsent Fee | CRA | ||||
| Record Request after Closeout | CRA | ||||||
| Remote Monitoring Charge or Training Outside of SIV for CRC, per hour | CRA | ||||||
| SAE at our site, each | CRA | Only use if SAE milestone is not used | |||||
| Sponsor/FDA/IRB Audit Fee, per day | CRA | Can be triggered by the Regulatory Coordinator | |||||
| Travel Expenses | CRA | Negotiated rate should remain $0.00. Subject sequence # and additional details should be documented in comments. | |||||
| Screen Failures, per patient | CRA | Only use if Screen Failure milestone is not used | |||||
| Annual Medication Storage Fee | IRB Review | Review Reason: Continuing Review | |||||
| Central IRB Continuing Review | IRB Review | Review Reason: Continuing Review | |||||
| Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Annual fee | IRB Review | Review Reason: Continuing Review | |||||
| IRB Annual Renewal Fee | IRB Review | Review Reason: Continuing Review | |||||
| Maintenance of Regulatory Documents, CVs, DOA Logs, 1572s, FD, Training, per year | IRB Review | Review Reason: Continuing Review | |||||
| Regulatory Renewal Fee | IRB Review | Review Reason: Continuing Review | |||||
| Research Pharmacy Annual fee | IRB Review | Review Reason: Continuing Review | |||||
| Biostatistician Fees | IRB Review | Review Reason: Initial Review | |||||
| Budget and Contract Review | IRB Review | Review Reason: Initial Review | |||||
| Central IRB Initial Review | IRB Review | Review Reason: Initial Review | |||||
| Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Initial Fee | IRB Review | Review Reason: Initial Review | |||||
| Coordinator Start-up fee | IRB Review | Review Reason: Initial Review | |||||
| Fast Track Fee - for Phase I only | IRB Review | Review Reason: Initial Review | |||||
| Initial Regulatory Preparation Fee | IRB Review | Review Reason: Initial Review | |||||
| Intial Medication Storage Fee | IRB Review | Review Reason: Initial Review | |||||
| IRB Initial Review | IRB Review | Review Reason: Initial Review | |||||
| Lab Start Up Costs | IRB Review | Review Reason: Initial Review | |||||
| Pre-Screening Funds | IRB Review | Review Reason: Initial Review | |||||
| Radiology Start Up Fee | IRB Review | Review Reason: Initial Review | |||||
| Research Pharmacy Initial Fee | IRB Review | Review Reason: Initial Review | |||||
| Study Start Up Fee | IRB Review | Review Reason: Initial Review | |||||
| Document Archiving | IRB Study Closure | Depending on contract language, could also use Review Type: IRB Review; Review Reason: Initial Review | |||||
| Study Close-out Fee | IRB Study Closure | ||||||
| Administrative IBC Fee | Add event trigger based on study use case needs | ||||||
| Advertisement & Recruitment | IRB Review -or- CRA | Use either review type depending on contract language | |||||
| Amendment Processing Fee | Depending on type of modifications the IRB Review trigger can be used | ||||||
| Cost Analysis | Add event trigger based on study use case needs | ||||||
| IRB fee for any Modification to initial Submission, includes protocol, ICF, IB, Recruit, etc., each | Depending on type of modifications the IRB Review trigger can be used | ||||||
| Other | Add event trigger based on study use case needs | ||||||
| Pharmacy Fees | Add event trigger based on study use case needs | ||||||
| Research Pharmacy charge for excessive monitoring visits, >6/yr, each | Should be invoiced at the time Pharmacy charges the study account | ||||||
| Research Pharmacy charge for Remote Monitoring or training, per hour | Should be invoiced at the time Pharmacy charges the study account |