HLVI Regulatory Services Group

The HLVI Regulatory Services Group His a team of well-qualified clinical research professionals dedicated to providing regulatory filings in support of clinical research. This includes IRB and FDA filings in support of industry and investigator-initiated trials. By using this centralized resource, HLVI investigators can be assured that regulatory compliance issues will be managed as expeditiously as possible according to the latest requirements and guidance.

Using the HLVI Regulatory Services Group for all IRB submissions is now mandatory to ensure strong compliance with GCP and IRB policies and to adequately support the novel work of the institute. The group is conveniently located in UCCOM MSB suite 6553 and are available online or for meetings with study teams.

HLVI Regulatory Services Fee Master

Investigator Consulting Services are available prior to initiating new regulatory submissions. Investigators may contact Jennifer Daniels, MS, HLVI Regulatory Services Group Manager to set an appointment to discuss new submissions or any regulatory concern.

Standard Intake Checklist

Standard operating polices govern the conduct of regulatory submissions by the group. A Standard Intake Checklist is available along with other useful templates to guide investigators through the process of development of the initial submission.

Standard Intake Checklist (PDF)

Investigator Training

Investigator Training for Clinical Research is available online to guide trial development.

CITI Training Guide

HLVI Regulatory Services Fee Master

HLVI Regulatory Services Group Staff are knowledgeable of the latest regulatory requirements and are well trained in the development of initial IRB submissions, amendments, reportable events and continuing reviews. Informed consent development or modification is part of the initial development for all new submissions.