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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.
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.