Regulatory Strategy Development
The Office of Research Integrity and Regulatory Affairs provides comprehensive regulatory support to UTMB research community in developing or conducting research with FDA-regulated products, including investigational drugs and medical devices, we offer
support with regulatory strategy development, FDA meetings, clinical research guidance and preparation and submission of regulatory applications.
The team may use a collaborative approach to manage increasing complexities when working with research investigators and study teams in the development of the study design and in navigating through the IND/IDE process submission pathway. Some helpful
hints to the Investigator:
- Initial UTMB sponsored IND and IDE applications are to be reviewed by Research Integrity & Regulatory Affairs prior to submission FDA.
- It is important that we receive copies of Investigator-Initiated sponsored IND and IDE submissions, any supplements, annual reports, and protocol amendments.
- Copies of any formal FDA or agency correspondences are retained.
Regulatory guidance is available on IND/IDE requirements, submissions, and applicable governmental laws regulations. For assistance, please contact Tina Mack-Moshay, email tlmackmo@utmb.edu.
Roles and Responsibilities
Submitting a Complete and Compliant Application
The Office of Research Integrity and Regulatory Affairs is here to support your research development project and submission efforts.
We care a lot about the details and the key points about your project! Not just to ensure we are following sponsor and regulatory requirements, but that we are helping you develop the best IND/IDE application possible.
To get started, it is generally best for the Investigator or delegate to send a brief introductory email and ask if there is a good time to set up a call to discuss your research goals and your program or research idea.
Principal Investigator (PI)
The Principal Investigator (PI) ensures that the application is complete, accurate, and meets all clinical trial and protocol study design requirements based on applicable law, regulatory requirements, proposal guidelines, administrative and compliance
requirements. The PI may delegate certain components of the IND/IDE application, annual and safety report preparation to the PI’s research team, Clinical research study administrator, or others within the research project team. The PI retains
oversight and overall responsibility for the protocol study content and all technical information supporting the IND/IDE portions of the submission relevant to the conduct of the research project including, but not limited to, determination that the
proposed drug/device is reasonably safe for initial use in humans and assessment for any unanticipated risks, procedures for administration and delivery of investigational product, information on qualification of each investigator/sub-investigator
and post-submission revisions as required for periodic annual and safety reports.
Research Integrity & Regulatory Affairs Administrator
The Regulatory Affairs Administrator reviews and completes UTMB IND or IDE sponsored applications for consistency using internal policies and procedures, federal regulations, and the information provided by the PI. The Regulatory Affairs Administrator
ensures that all components of the application or any drafted reports are compiled and assembled appropriately by the PI and research team and assists in the completion and approval of documents including the drafting of FDA Forms prior to FDA submission.
The Administrator is the primary contact for the FDA, receives comments and assists PI in responding to these comments by making necessary revisions to the submission in collaboration with the PI. Final copies of UTMB sponsored regulated documents
are retained in a central repository.
IND/IDE Application Final and Annual Reporting Timelines
Timeline for review of regulatory documents will vary based on the complexity of the research IND or IDE application and submission materials. As part of the review, we may identify issues that require remediation prior to
submission to FDA. The correction of identified issues may take time and could result in an additional review. We ask that you keep this in mind when planning for a regulatory review and submission.
- IND application Principal Investigator is expected to submit brief reports of the progress of the investigations and/or annual report conducted under their respective IND application within 60 days of the anniversary date that the application went into effect.
- IDE application at regular intervals and at least yearly, the Principal Investigator must provide progress reports to all reviewing IRBs. For a significant risk device, the sponsor must also submit the progress report to FDA.
- For approved IDE applications, every six months the Principal Investigator must submit to FDA a current list of the names and addresses of all investigators participating in a significant risk device investigation. [21 CFR 812.150(b)(4)]. FDA may
grant a waiver allowing the sponsor to submit a current list to FDA annually as part of the annual progress report, in lieu of every six months.