Extension Study

The following lists contain items and processes that may be completed to ensure compliance with the rules and regulations that govern clinical research. The below fees will be charged to the study account established for the protocol and shall be covered by the organization that is sponsoring or funding the clinical research:

Administrative Start-Up A one time non-refundable fee$9,850
CTMS Set-UpA one-time, non-refundable fee, if applicable$1,700
e-RegulatoryAn annual, non-refundable fee for CTU only$1,700
Administrative Annual FeeAn annual, non-refundable fee$3,215
AmendmentA non-refundable fee charged for each sponsor required IRB amendment and sponsor prompted budget or contract amendment
Financial $430
TrainingRequired additional protocol training for all personnel on DOA or 1572 through a sponsor system (per hour fee)Study personnel$60
Sponsor/FDA AuditPer day fee$615
Local SAE ReportingPer hour fee$85
IRB Initial ReviewA one-time fee$3,900
IRB Continuation ReviewAn annual fee$1,300
Administrative Close-OutA one-time, non-refundable fee$2,610
Archiving FeeA one time, non-refundable fee$1,215
Study Drug Storage and AccountabilityA one time non-refundable fee.  This applies only if study drug is stored in the unit.Ambient$1,180
Pharmacy (Pediatric Only)An annual non-refundable fee. This applies only if the study drug is stored in the unit's satellite pharmacy. Simple$4,825
Pharmacy Close-Out (Pediatric Only)A one time non-refundable fee.  This fee applies only if the study drug is stored in the unit's satellite pharmacy.$860

**Hospital facility fees are separate from the fee schedule above **


Email CTU for more information.