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:

Service

Description

Total

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

$9,300

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.

$7,750

Administrative Annual Fee /Registry, Extension and Specimen

An annual, non-refundable fee

$3,060

Administrative Annual Fee / Chart Review

An annual, non-refundable fee

$2,550

Amendment Fee

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

$525

Pre-Screening Fee

A non-refundable, quarterly fee, if applicable

$2,000

Drug or Device Storage

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

Training

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

Study personnel

$85

MD/PhD/PharmD

$225

Sponsor/FDA Audit

Per day fee

$650

Local SAE Reporting

Per report

$500

Administrative Close-Out

A one-time, non-refundable fee

$2,700

Archiving

A one-time, non-refundable fee 

$1,300

IRB Initial Review

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

$3,900

IRB Continuation Review

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

$1,300

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

 

Email CTU for more information.