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 | Trigger Type | Responsible Party | 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 | |
Central IRB Continuing Review | IRB Annual Review | | IRB Annual Renewal Fee | IRB Annual Review | |
| Maintenance of Regulatory Documents, CVs, DOA Logs, 1572s, FD, Training, per year | IRB Annual Review | |
| Regulatory Renewal Fee | IRB Annual Review | |
| Research Pharmacy Annual fee | IRB Annual Review | |
| Biostatistician Fees | IRB Initial Review | |
| Budget and Contract Review | IRB Initial Review | |
| Central IRB Initial Review | IRB Initial Review | |
| Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Initial Fee | IRB Initial Review | |
| Coordinator Start-up fee | IRB Initial Review | |
| 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 |
IRB Annual Review | | | 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 |
| Intial Medication Storage | should automatically come over from myIRB |
| IRB Annual Renewal Fee | IRB |
Initial Review | 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 |
Initial | - 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 |
| | Pre-Screening Funds | IRB Initial Review | |
| Radiology Start Up Fee | IRB Initial Review | |
| Research Pharmacy Initial Fee | IRB Initial Review | |
| Study Start Up Fee | IRB Initial Review | |
| Document Archiving | IRB Study Closure | Could also be IRB Initial Review depending on contract language |
| Study Close-out Fee | IRB Study Closure | |
Administrative IBC Fee | | 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 |
| Advertisement & Recruitment | | IRB Initial Review or CRA trigger 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 needsShould be invoiced at the time Pharmacy charges the study account |
| 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 |
| Should be invoiced at the time Pharmacy charges the study account | 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. |