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Event DescriptionTrigger TypeComments 
Additional MonitorCRA 
Central Lab ProcessingCRA 
Fee for Additional Sponsor Initiated Investigator MeetingCRA 
Hotel, per dayCRA 
IND Safety Reports processing, eachCRA 
LodgingCRA 
Mileage, per mile at current federal rateCRANegotiated rate should remain $0.00. Subject sequence # and additional details should be documented in comments. 
Monitor VisitsCRA 
Monitoring: CancelationCRA 
Monitoring: Change in Monitoring Staff, per eventCRA 
Monitoring: No Show, per eventCRA 
Not for Cause FDA AuditsCRA 
Reconsent FeeCRA 
Record Request after CloseoutCRA 
Remote Monitoring Charge or Training Outside of SIV for CRC, per hourCRA 
SAE at our site, eachCRAOnly use if SAE milestone is not used
Sponsor/FDA/IRB Audit Fee, per dayCRACan be triggered by the Regulatory Coordinator 
Travel ExpensesCRANegotiated rate should remain $0.00. Subject sequence # and additional details should be documented in comments. 
Screen Failures, per patientCRA Only use if Screen Failure milestone is not used
Annual Medication Storage FeeIRB Review

Review Reason: Continuing Review

Central IRB Continuing ReviewIRB Review

Review Reason: Continuing Review

Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Annual feeIRB Review

Review Reason: Continuing Review

IRB Annual Renewal FeeIRB Review

Review Reason: Continuing Review

Maintenance of Regulatory Documents, CVs, DOA Logs, 1572s, FD, Training, per yearIRB Review

Review Reason: Continuing Review

Regulatory Renewal FeeIRB Review

Review Reason: Continuing Review

Research Pharmacy Annual feeIRB Review

Review Reason: Continuing Review

Biostatistician FeesIRB Review

Review Reason: Initial Review

Budget and Contract ReviewIRB Review

Review Reason: Initial Review

Central IRB Initial ReviewIRB Review

Review Reason: Initial Review

Clinical Research Unit, Adult, CTRU or Pediatric, PRU, Initial FeeIRB Review

Review Reason: Initial Review

Coordinator Start-up feeIRB Review

Review Reason: Initial Review

Fast Track Fee - for Phase I onlyIRB Review

Review Reason: Initial Review

Initial Regulatory Preparation FeeIRB Review

Review Reason: Initial Review

Intial Medication Storage FeeIRB Review

Review Reason: Initial Review

IRB Initial ReviewIRB Review

Review Reason: Initial Review

Lab Start Up CostsIRB Review

Review Reason: Initial Review

Pre-Screening FundsIRB Review

Review Reason: Initial Review

Radiology Start Up FeeIRB Review

Review Reason: Initial Review

Research Pharmacy Initial FeeIRB Review

Review Reason: Initial Review

Study Start Up FeeIRB Review

Review Reason: Initial Review

Document ArchivingIRB Study ClosureDepending on contract language, could also use
Review Type: IRB Review; Review Reason: Initial Review
Study Close-out FeeIRB Study Closure 
Administrative IBC Fee Add event trigger based on study use case needs
Advertisement & RecruitmentIRB Review -or- CRAUse 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