IRB Forms Checklists Protocol Preparation Checklist Checklist – Transition 2018 Common Rule Checklist – Continuing Review (Long CPA) Checklist – Continuing Review (Short CPA) Checklist – Emergency Use of a Test Article Checklist – Exempt Research Checklist – Informed Consent Checklist – Modification Checklist – New Expedited or Full Committee Research Checklist – NIH Genomic…

Lead Researcher Eligibility Differences Between Lead Researcher and Principal Investigator Principal Investigator eligibility for a Contract or Grant is separate from Lead Researcher eligibility for conducting research with human subjects or animals. In making this distinction, UCI recognizes both the added responsibility associated with research involving humans or animals, and the research contributions of all…

National Cancer Institute Central IRB (CIRB) Independent Review Process Overview of the CIRB Initiative The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI).  The Adult NCI CIRB reviews Cooperative Group trials from the ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC, NSABP, RTOG, and SWOG, as well as any other studies…

Commercial IRB Reliance Agreements Advarra IRB What is Advarra? What Type of Studies Qualify for Advarra Review? How do I obtain clearance from UCI to submit to Advarra? Advarra Submission and Review Process Resources What is Advarra? What is Advarra? Advarra Institutional Review Board (IRB) is an independent IRB formed in 2017 from the merging…

Expanded Access to Unapproved Devices There are two options for treating patients with an unapproved medical device outside of a clinical trial. One option is Expanded Access. The other is Right to Try. FDA Expanded Access eRequestA web-based tool that enables physicians to complete, sign, and submit non-emergency Expanded Access (EA) requests to FDA Use…

Drugs and  Biologics Used in Clinical Research Per FDA, Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements…

What is ClinicalTrials.gov? ClinicalTrials.gov is a resource that provides access to information on clinical trials studying a wide range of diseases, conditions and interventions. Studies listed in the database are conducted in all 50 States and worldwide. Each ClinicalTrials.gov record includes summary information about studies. EQUIP TIP: The clinicaltrials.gov record may be released for PRS review AFTER IRB submission. Registration…

Department of Defense Research Requirements Background The Department of Defense (DOD) IS a signatory to the Revised Common Rule, which took effect January 21, 2019.   To determine additional applicability and requirements when conducting DoD supported research, view the DoD Instruction 3216.02. The IRB Application in Kuali Research Protocols addresses DoD requirements. Specific branches of the…

Ancillary Processes & Partners Before the IRB can approve research, there are other prerequisite UCI reviews that may be required. Please review the below links or inspect the quick reference Chart of Ancillary UCI Reviews. Chart of Ancillary UCI ReviewsThis Reference document outlines UCI IRB review and approval timeframe with other ancillary processes and committees.…