Below is the Center for Clinical Studies' list of recommended Protocol-Related Event Triggers. We understand that study teams have variable invoicing needs, so these triggers are meant as suggestions and not requirements.
| Event Description | Event Trigger | 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 | |
| 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 |
number | # and additional details should be documented in |
the | comments. |
| Screen Failures, per patient | CRA | Only use if Screen Failure milestone is not used |
| Annual Medication Storage Fee | IRB |
Annual Review Reason: Continuing Review |
| Central IRB Continuing Review | IRB |
Annual Review Reason: Continuing Review |
| Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Annual fee | IRB |
Annual Review Reason: Continuing Review |
| IRB Annual Renewal Fee | IRB |
Annual Review Reason: Continuing Review |
| Maintenance of Regulatory Documents, CVs, DOA Logs, 1572s, FD, Training, per year | IRB |
Annual Review Reason: Continuing Review |
| Regulatory Renewal Fee | IRB |
Annual Review Reason: Continuing Review |
| Research Pharmacy Annual fee | IRB |
Annual 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 |
Could also be IRB Initial Review depending on contract languageDepending 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 |
Initial trigger | 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 |