Do you need regulatory help at your research site?

The CCTS Regulatory Component provides an array of guidance and support for UTHSC PIs and clinical staff who are conducting research- and are here to help you!

Assistance includes:

-Interpretation of federal regulations regarding specific protocols
-Drug and Device exemption qualifications and determinations
-IND/IDE submissions and reviews prior to filing
-Pre-IND Meetings and requests
-Annual Reporting
-Adverse Event reporting to the FDA and IRB
-Study monitoring guidelines
-Investigator Obligations
-Site level regulatory and essential documents keeping and maintenance
-Site selection preparations
-Audit preparations for the FDA, Sponsor, and 3rd parties
-Education and training in the conduct of clinical research in human subjects
-Site SOPs
-Data Safety Monitoring Boards
-Clinicaltrials.gov determinations and registrations

We also help with answering any questions that may arise during the course of a study, from start-up to closeout.  

“Who all should be listed in box 6 of the FDA Form 1572?”

Generally, those individuals who provide a high level of responsibility to the study are included in box 6 of the 1572. Licensed study team members who perform study related procedures, or who provide pivotal contributions to the data being secured are typically listed here. Hospital staff who provide indirect and unrelated care do not need to be listed.

“Can non-physicians ever be Principal Investigators and listed in box 1 of the FDA Form 1572?”

Being a licensed M.D, D.O., D.D.S., is not a requirement for being a PI, however studies with non-licensed PIs generally include a sub-investigator listed in box 6 who will provide the medical oversight and responsibility of subjects participating in the research.

Please call us if you have any questions in making these decisions!

Contact:

Gena Monroe                                          Catey Carter, BSN, RN, CCRC,
Sr. Regulatory Affairs Specialist      Clinical Trials Resource Coordinator
713-500-7903                                     713-500-7910
Gena.Monroe@uth.tmc.edu            Catharine.V.Carter@uth.tmc.edu