We provide regulatory support to investigators within University of Arizona Health Sciences. We have dedicated staff with many years of experience available to guide and assist with the IRB and regulatory processes. Regulatory services include:
- Support to PIs and research staff with preparing, finalizing, and submitting completed applications and authorizations to the IRB (local and commercial) for new projects, modifications, deferrals, partial HIPAA waivers, consent form revisions, advertising, continuing review, safety/AE and protocol deviations.
- Assistance with processing regulatory start up documents (1572, financial disclosures, protocol signature page, site contact form, etc.), obtaining signatures and returning completed documents to Sponsor.
- Protocol and Informed Consent development, support, review, and expertise for investigator-initiated studies.
- Maintenance of electronic files and hard copy regulatory binders for assigned studies.
- Assistance with ClinicalTrials.gov submissions including closeout and posting of results for concluded studies.
- Assistance with Retrospective Chart Review Submissions.
If you would like to utilize our services, please send us an email at firstname.lastname@example.org.
Kerry-Ann Suckra, MS
Coordinator, Regulatory Affairs