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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

Fee for Additional Sponsor Initiated Investigator MeetingCRA IND Safety Reports processing, eachCRA 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 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 usedSponsor/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 usedAnnual Medication Storage FeeIRB Review

Review Reason: Continuing Review

Central IRB Continuing ReviewIRB ReviewReview Reason: Continuing ReviewIRB 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 ReviewReview Reason: 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 Review

Review Reason: Continuing Review

Intial Medication Storage

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

Review Reason: Initial Review

Regulatory	Review should automatically come over from myIRB
IRB Annual Renewal Fee	IRB Review - Continuing Review

Review Reason: Initial 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

Review Reason: Initial ReviewPre-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 ReviewStudy Close-out FeeIRB Study Closure Administrative IBC Fee

Regulatory	Review should automatically come over from myIRB
Lab Start Up Costs	IRB Review - Initial or Request to Rely

Review Reason: Initial Review

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

Advertisement & Recruitment


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 -

CRAUse either review type depending on contract languageAmendment Processing Fee Depending on type of modifications the IRB Review trigger can be usedCost Analysis Add event trigger based on study use case needsIRB 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 usedOther Add event trigger based on study use case needsPharmacy Fees Add event trigger based on study use case needs

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

Should be invoiced at the time Pharmacy charges the study account

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.

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