eReg workflow assistance is provided by Regulatory Support at UAHS Research Administration.
Regulatory Support assists investigators within University of Arizona Health Sciences with dedicated staff available to guide researchers through 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.