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| Event Description | Trigger Type | Responsible Party | Comments | ||
| Additional Monitor | CRA | Coordinator | Log in CRA Console → Financial Events | ||
| Administrative IBC Fee | Add event trigger based on study use case needs | ||||
| Advertisement & Recruitment | IRB Review Initial -or- CRA | Regulatory or Coordinator | Use either review type depending on contract language (IRB Review if paid upfront, CRA if paid as occurs) | ||
| Amendment Processing Fee | CRA | Regulatory | Log in CRA Console → Financial Events | ||
Annual Medication Storage Fee | Date Based | Financial Team | Set date yearly based on contract execution date | ||
| Annual Radiology Fee | Date Based | Financial Team | Set date yearly based on contract execution date | ||
| Annual Regulatory & IRB Preparation Fee | IRB Review - Continuing Review or CRA | Regulatory | Local IRB would use IRB trigger, Central IRB would use CRA trigger | ||
| Biostatistician Fees | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB | ||
| Budget and Contract Review | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB | ||
| Central IRB Continuing Review | IRB Review - Continuing Review | Regulatory | Regulatory manually logs review in PC Console → Reviews | ||
| Central IRB Initial Review | IRB Review - Request to Rely | Regulatory | Review should automatically come over from myIRB | ||
| Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Annual fee | Date Based | Financial Team | Set date yearly based on contract execution date | ||
| Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Initial Fee | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB | ||
| Coordinator Start-up fee | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB | ||
| Cost Analysis | Add event trigger based on study use case needs | ||||
| Document Archiving | IRB Study Closure | Team Lead / Coordinator | Triggered by status change in PC Console. Depending on contract language, could also use IRB Review-Initial or Request to Rely | ||
| 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 | ||
| Regulatory Close-Out Fee | IRB Study Closure | Team Lead / Coordinator | Triggered by status change in PC Console. | ||
| 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 Study Closure | Team Lead / Coordinator | Triggered by status change in PC Console. | ||
| Study Start Up Fee | IRB Review - Initial or Request to Rely | Regulatory | Review should automatically come over from myIRB | ||
| Travel Expenses | CRA | Coordinator | Log in CRA Console → Financial Events. Negotiated rate should remain $0.00. Subject sequence # and additional details should be documented in comments. |