Registry, Extension and Specimen 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 /Registry, Extension and Specimen

A one-time, non-refundable fee for studies:

1)     observational studies in which the events with a specific disease or condition are recorded without predefined treatment or ongoing treatment from a previous study/marketed product.

2)     specimen studies in which samples are collected


Administrative Start-Up/ Chart Review

A one-time, non-refundable fee for studies which only require the collection of existing clinical data from a medical chart.


Administrative Annual Fee /Registry, Extension and Specimen

An annual, non-refundable fee


Administrative Annual Fee / Chart Review

An annual, non-refundable fee


Amendment Fee

A non-refundable fee charged for each sponsor required IRB amendment and sponsor prompted budget or contract amendment


Pre-Screening Fee

A non-refundable, quarterly fee, if applicable


Drug or Device Storage

See fee structure for Clinical Trials for Extension study charges for drug or device.


Required additional protocol training for all personnel on DOA or 1572 through a sponsor system (per hour fee)

Study personnel




Sponsor/FDA Audit

Per day fee


Local SAE Reporting

Per report


Administrative Close-Out

A one-time, non-refundable fee



A one-time, non-refundable fee 


IRB Initial Review

A one-time fee inclusive of F/A as published on the IRB website


IRB Continuation Review

An annual fee inclusive of F/A as published on the IRB website


** Facility fees are separate from the fee schedule above **


Email CTU for more information.