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 $9,850
CTMS Set-Up A one-time, non-refundable fee, if applicable $1,700
e-Regulatory An Initial fee at start-up and annually thereafter, non-refundable $1,700
Administrative Annual Fee An annual, non-refundable fee $3,215
Amendment A non-refundable fee charged for each sponsor required IRB amendment and sponsor prompted budget or contract amendment
Regulatory $490
Financial $430
Training Required additional protocol training for all personnel on DOA or 1572 through a sponsor system (per hour fee) Study personnel $60
MD/PhD/PharmD $215
Sponsor/FDA Audit Per day fee $615
Local SAE Reporting Per hour fee $85
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 $2,610
Archiving Fee A one time, non-refundable fee $1,215
Study Drug Storage and Accountability A one time non-refundable fee.  This applies only if study drug is stored in the unit. Ambient $1,180
Refrigerated $1,715
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
Complex $5,520
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.