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:

Procedure Description Total
Administrative Start-Up  A one time non-refundable fee $11,897
CTMS Set-Up A one-time, non-refundable fee, if applicable $1,751
Administrative Annual Fee An annual, non-refundable fee $5,062
Amendment A non-refundable fee charged for each sponsor required IRB amendment and sponsor prompted budget or contract amendment
Regulatory $505
Financial $443
Training Required additional protocol training for all personnel on DOA or 1572 through a sponsor system (per hour fee) Study personnel $62
MD/PhD/PharmD $221
Sponsor/FDA Audit Per day fee $633
Local SAE Reporting Per hour fee $88
IRB Initial Review A one-time fee $3,900
IRB Continuation Review An annual fee $1,300
Administrative Close-Out A one-time, non-refundable fee $2,688
Archiving Fee A one time, non-refundable fee $1,251
Study Drug Storage and Accountability A one time non-refundable fee.  This applies only if study drug is stored in the unit. Ambient $1,215
Refrigerated $1,766
Pharmacy (Pediatric Only) An annual non-refundable fee. This applies only if the study drug is stored in the unit's satellite pharmacy. Simple $4,970
Complex $5,686
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. $886

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


Email CTU for more information.