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Fast Track Fee - for Phase I only | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB |
Fee for Additional Sponsor Initiated Investigator Meeting | CRA | Coordinator | Log in CRA Console → Financial Events |
IND Safety Reports processing, each | CRA | Coordinator | Log in CRA Console → Financial Events |
Initial Medication Storage Fee | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB |
Initial Regulatory Preparation Fee | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB |
IRB Annual Renewal Fee | IRB Review - Continuing Review | Regulatory | Review should automatically come over from myIRB |
IRB fee for any Modification to initial Submission, includes protocol, ICF, IB, Recruit, etc., each | CRA | Regulatory | Log in CRA Console → Financial Events |
IRB Initial Review | IRB Review - Initial | Regulatory | Review should automatically come over from myIRB |
Lab Start Up Costs | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB |
Maintenance of Regulatory Documents, CVs, DOA Logs, 1572s, FD, Training, per year | Date Based | Financial Team | Set date yearly based on contract execution date |
Mileage, per mile at current federal rate | CRA | Coordinator | Log in CRA Console → Financial Events. Negotiated rate should remain $0.00. Subject sequence # and additional details should be documented in comments. |
Monitor Visits | CRA | Coordinator | Log in CRA Console → Financial Events |
Monitoring: Cancelation | CRA | Coordinator | Log in CRA Console → Financial Events |
Monitoring: Change in Monitoring Staff, per event | CRA | Coordinator | Log in CRA Console → Financial Events |
Monitoring: No Show, per event | CRA | Coordinator | Log in CRA Console → Financial Events |
Not for Cause FDA Audits | CRA | Coordinator | Log in CRA Console → Financial Events |
Other | | | Add event trigger based on study use case needs |
Pharmacy Fees | CRA | Financial Team | Log in CRA Console → Financial Events |
Pre-Screening Funds | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB |
Radiology Start Up Fee | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB |
Record Request after Closeout | CRA | Coordinator | Log in CRA Console → Financial Events |
Regulatory Renewal Fee | IRB Review - Continuing Review | Regulatory | If Central IRB, Regulatory manually logs review in PC Console → Reviews. If local IRB, review should automatically come over from myIRB |
Remote Monitoring Charge or Training Outside of SIV for CRC, per hour | CRA | Coordinator | Log in CRA Console → Financial Events |
Research Pharmacy Annual fee | Date Based | Financial Team | Set date yearly based on contract execution date |
Research Pharmacy charge for excessive monitoring visits, >6/yr, each | CRA | Financial Team | Log in CRA Console → Financial Events |
Research Pharmacy charge for Remote Monitoring or training, per hour | CRA | Financial Team | Log in CRA Console → Financial Events |
Research Pharmacy Initial Fee | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB |
SAE at our site, each | CRA | Coordinator | Only use if SAE milestone is not used. Log in CRA Console → Financial Events |
Screen Failures, per patient | CRA | Coordinator | Only use if Screen Failure milestone is not used. Log in CRA Console → Financial Events |
Sponsor/FDA/IRB Audit Fee, per day | CRA | Coordinator or Regulatory | Log in CRA Console → Financial Events |
Study Close-out Fee | IRB |