2. 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	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 Management Annual Fee	Date Based	Financial Team	Set date yearly based on contract execution date
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.