Announcement of the Creation of the Clinical Investigator Resource Core
The Department of Clinical Sciences is pleased to announce the creation of the Clinical Investigator Resource Core (CIRC), a central information and implementation service for all clinical and translational investigators at UT Southwestern and other CTSA partnering institutions.
Do you have a question about what the CTSA can do for you? Do you have a need and don’t know where to go or who might help? Do you need internal review, support or resource to initiate your study? Are you wondering what the Department of Clinical Sciences can do to make your research proposal more competitive? Do you need help with the paperwork needed to do clinical or translational research? Do you have a simple question and don’t know who might have the answer?
Then you need to contact the Clinical Investigator Resource Core!
When fully operational, the Clinical Investigator Resource Core (CIRC) will provide a comprehensive concierge service and assistance for all aspects of clinical and translational research. Currently, the CIRC is open and can be contacted at CIRC@UTSouthwestern.edu. The CIRC is available to provide the following services:
1. Basic Consultative Services (services provided free of charge)
• General information or brief consultation regarding availability of resources and services to support clinical and translational research at UT Southwestern Medical Center and at CTSA partnering institutions.
• Education and training in the regulatory requirements for clinical research. A brief (about 1 hour) training session with research personnel to review regulatory requirements and documents needed for an IRB submission.
• Pre-review of investigator-prepared regulatory documents. A review of all draft documents prior to submission to the IRB to assure they are complete, correct and consistent.
2. Intermediate Consultative Services ($60.00 per hour)
• 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.)
3. Advanced Consultative Services ($100.00 per hour. 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.
May 27, 2008
