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RRC Scope and Purpose
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SERVICES 

T.A.B.S. Research Review Committee offers the following services: 

 

Weekly Meetings

Three day delivery services of approved documents to researcher or investigator

Same day expedited approval for items allowed under FDA regulations

One month notification of Progress Reports due sent to researcher, investigator and sponsor

RRC forms, instructions, sample documents available on diskette using MS Word for Windows or WordPerfect

One time review fee per study protocol

Discount for Multi-Center Studies

Instruction Booklets for researcher, investigator and sponsor

In-Service Training Programs

Product Design Review

Protocol Development

Clinical Monitoring for research and clinical studies

Development of Software Programs for data analysis

Statistical Analysis  

 

    FEE SCHEDULE

These fees are one time charges for all standard services provided by T.A.B.S.

Exceptions:

1.  The need to engage an outside consultant to assist in the review of projects which require expertise beyond or in addition to that available from the RRC members will result in additional fees.

 2.   Verification of informed consents submitted for approval in a different language than initially approved will be billed at $ 200.00 per informed consent per study, provided that each investigator uses the same approved document.

First Investigative site           $ 1500.00 per protocol

     1 -   25 additional sites   $   750.00 per investigator

   26 -   50 additional sites   $   600.00 per investigator

   51 -   75 additional sites   $   550.00 per investigator

   76 - 100 additional sites   $   450.00 per investigator

 101 + additional sites         $   400.00 per investigator

Review of Protocol :     $ 1500.00

Includes continuing review during first year

Review of Investigator:    ***   

            Includes review of patient informed consent form; verification of investigator licenser; review of curriculum vitae; investigator information, i.e., patient ethnic information, number of studies, facilities, etc.; review of advertisements; site visits, as appropriate.

Ongoing Review:$  400/Site

Review of studies ongoing for more than one year;

Includes review of : protocol and amendments,

quarterly reports, adverse event reports, verification

of approved consent form, number of subjects enrolled

For a printable Microsoft Word version of the above information click on the link below.

SERVICES

Copyright 2006 Texas Applied Biomedical Services Inc. All rights reserved

 


 

T.A.B.S. provides a full range of Clinical Investigation/Study Services for the Medical Device Industry.