Regulatory Services

Thank you for your interest in working with the UAHS Research Administration (RA) Regulatory team on your study! Regulatory coordination is a service that is available to any UAHS faculty member who is conducting human subject’s research.

Below, is a brief overview of the study tasks that our team can perform for your study, as well as the tasks that remain the responsibility of the Principal Investigator (PI) and study team. The PI has direct responsibility and oversight for the conduct and compliance of all aspects of the study.

We encourage you to review the IRB’s guidance on PI responsibilities here.

UAHS RA Regulatory Responsibilities

  • Complete IRB (UA and/or central IRBs) and RIA submissions for initial approval, continuing review, amendments, and study closure
  • Assist with any required biosafety reviews
  • Assist with completion of regulatory documents such as the 1572
  • Provide approval letters and approved documents to the study team
  • Assist with preparation for monitoring visits and other assessments
  • Enter regulatory information into OnCore
  • Communicate with the sponsor about regulatory documents and timelines
  • Maintain electronic regulatory binder through eReg
  • Maintain general staff training records (e.g., CITI, UA HIPAA, COI, etc.)
  • For investigator-initiated studies only: help creating consent forms and protocols based on UA IRB templates (for all other studies, consent templates and protocol must be provided by the sponsor or study team)

PI and Study Team Responsibilities

  • Provide the Regulatory team with complete and accurate study documents and information about the study
  • Approvals for UA study sites outside the PI’s department and external non-Banner sites
  • Notify the Regulatory team of changes to protocol, IRB-approved documents, and study staff
  • Manage monitoring visits, audits, and other study reviews by sponsor, IRB, or other organizations, as well as self-assessments
  • Enter subject data into OnCore
  • Maintain any physical regulatory binder
  • Manage all study documentation that does not require IRB review (e.g. lab or pharmacy manuals, SOPs, source documents, etc.)
  • ClinicalTrials.gov entry and record maintenance (as applicable)
  • Protocol-specific training and delegation of authority logs

The UAHS RA Regulatory Team can be contacted at regulatory@arizona.edu for questions and requests.

Contact Us

Kirsten Anderson, MPH MSW
Senior Coordinator, Regulatory
(520) 621-6417
kirstena@arizona.edu
Find us on Microsoft Bookings.

Gustavo E. Cornejo
Coordinator, Regulatory
(520) 621-7288
gecornejo@arizona.edu
Find us on Microsoft Bookings