Clinical Investigator Resource Core
The Clinical Investigator Resource Core (CIRC) provides services and information for all clinical and translational investigators at both UT Southwestern and the Center for Translational Medicine's Partnering Institutions. Its purpose is to provide assistance in research protocol IRB submissions, conduct pre-reviews of regulatory documents, and support education regarding regulatory requirements.
Basic Consultative Services
Free of charge, the CIRC provides:
- 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, and
- 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 (please log in to the eIRB site to access pre-review).
*Pre-review includes a comprehensive review of all draft documents to assure they are completed correctly and that the information presented is consistent among the study documents. In addition, the protocol review includes analysis of the research question(s), background information (previous work, literature references), use of a study drug or device, comparison to standard of care, use of a placebo, inclusion and exclusion criteria, recruitment procedures, data collection, risks, safety precautions, protection of confidentiality, potential benefits, and biostatistical analysis. This review is done to assist investigators in presenting complete, accurate, and thorough applications prior to submission to the IRB. Review is of full board, exempt, and expedited submissions. A pre-review usually takes less than two business days and typically results in a significant decrease in the time required to attain final approval of the protocol.
Intermediate Consultative Services
For a fee, the CIRC provides:
- Preparation of regulatory documents for submission to the IRB and the sponsor (generally this requires about ten hours for a typical, uncomplicated, industry-sponsored protocol),
- Preparation of regulatory documents for submission to the IRB for an exempt or expedited study (generally this requires about six hours for a typical pilot study), and
- Preparation of, or guidance concerning, budgets for research studies (generally this requires about five hours for a typical industry-sponsored protocol).
Advanced Consultative Services
Increased fee structure; time estimates vary depending upon the complexity of the protocol.
- Preparation of/comprehensive consultation regarding an Investigational New Drug or Investigational Device Exemption to the FDA
- Protocol development and consultation
- Preparation of study initiation documents
- Preparation of regulatory binders
- Preparation for an FDA audit
- Other complex regulatory activities or filings