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 DescriptionTrigger TypeResponsible PartyComments 
Additional MonitorCRACoordinatorLog in CRA Console → Financial Events
Administrative IBC Fee

Add event trigger based on study use case needs
Advertisement & RecruitmentIRB Review Initial -or- CRARegulatory or CoordinatorUse either review type depending on contract language (IRB Review if paid upfront, CRA if paid as occurs)
Amendment Processing FeeCRARegulatoryLog in CRA Console → Financial Events

Annual Medication Storage Fee

Date BasedFinancial TeamSet date yearly based on contract execution date
Annual Radiology FeeDate BasedFinancial TeamSet date yearly based on contract execution date
Annual Regulatory & IRB Preparation FeeIRB Review - Continuing Review or CRARegulatoryLocal IRB would use IRB trigger, Central IRB would use CRA trigger
Biostatistician FeesIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Budget and Contract ReviewIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Central IRB Continuing ReviewIRB Review - Continuing ReviewRegulatoryRegulatory manually logs review in PC Console → Reviews
Central IRB Initial ReviewIRB Review - Request to RelyRegulatoryReview should automatically come over from myIRB
Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Annual feeDate BasedFinancial TeamSet date yearly based on contract execution date
Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Initial FeeIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Coordinator Start-up feeIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Cost Analysis

Add event trigger based on study use case needs
Document ArchivingIRB Study ClosureTeam Lead / CoordinatorTriggered 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 onlyIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Fee for Additional Sponsor Initiated Investigator MeetingCRACoordinatorLog in CRA Console → Financial Events
IND Safety Reports processing, eachCRACoordinatorLog in CRA Console → Financial Events
Initial Medication Storage FeeIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Initial Regulatory Preparation FeeIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
IRB Annual Renewal FeeIRB Review - Continuing ReviewRegulatoryReview should automatically come over from myIRB
IRB fee for any Modification to initial Submission, includes protocol, ICF, IB, Recruit, etc., eachCRARegulatoryLog in CRA Console → Financial Events
IRB Initial ReviewIRB Review - Initial RegulatoryReview should automatically come over from myIRB
Lab Start Up CostsIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Maintenance of Regulatory Documents, CVs, DOA Logs, 1572s, FD, Training, per yearDate BasedFinancial TeamSet date yearly based on contract execution date
Mileage, per mile at current federal rateCRACoordinatorLog in CRA Console → Financial Events.  Negotiated rate should remain $0.00. Subject sequence # and additional details should be documented in comments. 
Monitor VisitsCRACoordinatorLog in CRA Console → Financial Events
Monitoring: CancelationCRACoordinatorLog in CRA Console → Financial Events
Monitoring: Change in Monitoring Staff, per eventCRACoordinatorLog in CRA Console → Financial Events
Monitoring: No Show, per eventCRACoordinatorLog in CRA Console → Financial Events
Not for Cause FDA AuditsCRACoordinatorLog in CRA Console → Financial Events
Other

Add event trigger based on study use case needs
Pharmacy FeesCRAFinancial TeamLog in CRA Console → Financial Events
Pre-Screening FundsIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Radiology Start Up FeeIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Record Request after CloseoutCRACoordinatorLog in CRA Console → Financial Events
Regulatory Renewal FeeIRB Review - Continuing ReviewRegulatoryIf Central IRB, Regulatory manually logs review in PC Console → Reviews.  If local IRB, review should automatically come over from myIRB
Regulatory Close-Out FeeIRB Study ClosureTeam Lead / CoordinatorTriggered by status change in PC Console.
Remote Monitoring Charge or Training Outside of SIV for CRC, per hourCRACoordinatorLog in CRA Console → Financial Events
Research Pharmacy Annual feeDate BasedFinancial TeamSet date yearly based on contract execution date
Research Pharmacy charge for excessive monitoring visits, >6/yr, eachCRAFinancial TeamLog in CRA Console → Financial Events
Research Pharmacy charge for Remote Monitoring or training, per hourCRAFinancial TeamLog in CRA Console → Financial Events
Research Pharmacy Initial FeeIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
SAE at our site, eachCRACoordinatorOnly use if SAE milestone is not used. Log in CRA Console → Financial Events
Screen Failures, per patientCRA CoordinatorOnly use if Screen Failure milestone is not used. Log in CRA Console → Financial Events
Sponsor/FDA/IRB Audit Fee, per dayCRACoordinator or RegulatoryLog in CRA Console → Financial Events
Study Close-out FeeIRB Study ClosureTeam Lead / CoordinatorTriggered by status change in PC Console.
Study Start Up FeeIRB Review - Initial or Request to RelyRegulatoryReview should automatically come over from myIRB
Travel ExpensesCRACoordinatorLog in CRA Console → Financial Events.  Negotiated rate should remain $0.00. Subject sequence # and additional details should be documented in comments. 

Need more help? Contact the OnCore Support Team: oncore@wustl.edu