Research Administration Regulatory
Regulatory Services
Thank you for your interest in working with the U of A Health Sciences Research Administration regulatory team on your study. Regulatory coordination is a service that is available to any U of A Health Sciences faculty member who is conducting human subjects research. To get started, please complete the first three pages of the Regulatory Startup Questionnaire and email it to regulatory@arizona.edu.
Below is a brief overview of the tasks that our team can perform for your study, as well as the tasks that remain the responsibility of the principal investigator and the study team. The principal investigator has direct responsibility and oversight for the conduct and compliance of all aspects of the study. Our complete policy on Regulatory Management Responsibilities is available here.
- Complete IRB (U of A and/or central IRBs) and RAP 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, U of A HIPAA, COI, etc.)
- For investigator-initiated studies only: help create consent forms and protocols based on U of A IRB templates (for all other studies, consent templates and protocols must be provided by the sponsor or study team)
- Provide the regulatory team with complete and accurate study documents and information about the study
- Approvals for U of A study sites outside the principal investigator’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
Contact Us
Kirsten Anderson, MPH MSW
Senior Coordinator, Regulatory
(520) 621-6417
kirstena@arizona.edu
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Gustavo E. Cornejo
Senior Coordinator, Regulatory
(520) 621-7288
gecornejo@arizona.edu
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The U of A Health Sciences Research Administration regulatory team can be contacted at regulatory@arizona.edu for questions and requests.