Clinical Investigator Resource Core (CIRC) Services

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	Clinical Research Scholar Program

CIRC Services is a part of the Department of Clinical Sciences that provides services and information for all clinical and translational investigators at UT Southwestern Medical Center and its CTSA Partnering Institutions.

Our purpose is to provide assistance in research protocol IRB submissions, conduct pre-reviews of regulatory documents, and support education regarding regulatory requirements.

How Can We Help You?

The following services are available through the CIRC Office. Some of our services are free, and others are offered for a fee. You can also contact the CIRC Services Office for details (CIRC@UTSouthwestern.edu).

Basic Consultative Services (provided free of charge)

General information or brief consultation regarding availability of resources and services to support clinical and translational research.
Education and training in meeting regulatory requirements for clinical research.
Pre-review of investigator-prepared regulatory documents: a review of all draft documents prior to submission to the IRB to ensure that they are complete, correct, and consistent (CIRC Pre-Review Instructions).

Intermediate Consultative Services ($60/hr)

Preparation of regulatory documents for submission to the IRB and the sponsor. (In general this requires about 10 hours for a typical, uncomplicated, industry-sponsored protocol.)
Preparation of regulatory documents for submission to the IRB for an exempt or expedited study. (In general this requires about 6 hours for a typical pilot study.)
Preparation of, or guidance concerning, budgets for research studies. (In general this requires about 5 hours for a typical industry-sponsored protocol.)
Preparation of study initiation documents (study notebook). (In general this requires about 10 hours for a typical industry-sponsored protocol.)

Advanced Consultative Services ($100/hr; time estimates vary depending upon the complexity of the protocol.)

Preparation of an IND or IDE to the FDA.
Other complex regulatory activities or filings.

Contact the CIRC Services Office for details (214-648-5005) or CIRC@UTSouthwestern.edu.

CIRC Services are supported in part by a Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH).