Recommended Protocol-Related Event Triggers

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	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
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