Office of Human Research

Leadership

Positions:
  • Director, Office of Human Research
  • Director, Clinical Research Unit
  • Professor, SKMC Department of Pharmacology & Experimental Therapeutics
Contact Number(s):

For Research Activities

Positions:
  • Senior Associate Provost, Research Integrity, Conduct & Compliance
  • Professor, SKMC Department of Pathology, Anatomy & Cell Biology
Contact Number(s):

iRIS Workflows

Use the following links to open iRIS workflows in PDF form that will explain how to complete specific tasks within iRIS. If you would like to meet with a member of our staff to asks questions not addressed in these workflows, you can attend a Help Desk session hosted by OHR staff on Wednesday mornings. You can also submit a Service Now request.   

Submitting a New Study Application

Submitting a New Study (PDF) This workflow will walk a user through submitting a new study. Please note: This workflow walks through a basic chart review example, experience may vary based on decision branching logic. 
Responding to Stipulations (PDF) This workflow will walk a user through responding to stipulations requested by the IRB. 
Resubmitting a Not Approved Study (PDF) This workflow will walk a user through resubmitting a protocol that was Not Approved. 
Routing a New Study for Signatures (PDF) This workflow will walk a user through routing a new study application for signatures. Please note: Signatures are required from th Principal Investigator, Department Chair, and Business Administrator for all new studies. 
Modify a Signature Request After Submission (PDF) This workflow will walk a user through modifying signature requests to either remove and/or add signatory requests while the study is in draft. 
Completing a Signoff Task (PDF) This workflow will walk a user through completing a signoff task in iRIS. 
Check the Assigned Analyst (PDF) This workflow will walk a user through finding the analyst assigned to a transaction.  The analyst is the best person to reach out to with any questions or concerns regarding a particular transaction. 
Non-Jefferson IRB Submission Requirements (PDF) This document details the required components for submissions to different external IRBs.

Managing an Existing Study

Creating a Master Application (PDF) This workflow will walk a user through creating a Master Application for a migrated study that was approved prior to iRIS go-live. 
Submitting a Change of Principal Investigator (PDF) This workflow will walk a user through changing the PI for a study. 
Submitting a Continuing Review or Final Report (PDF) This workflow will walk a user through creating a continuing review or final report. 
Submitting an Amendment (PDF) This workflow will walk a user through creating an amendment. 
Submitting a Personnel Change Form (PDF) This workflow will walk a user through submitting a personnel change form to add or remove users for approved studies. 
Locating Study Documents (PDF) This workflow will walk a user through locating study documents. 
Viewing Study Details (PDF) This workflow will walk a user through viewing details for approved studies, such as expiration date, approved study personnel, inclusion/excusion criteria, etc. 
Locate Outcome Letters (PDF) This workflow will walk a user through locating outcome letters in iRIS. 
Delete a Submission Form (PDF) This workflow will walk a user through deleting a submission form. 

Board Member Resources

Access Comments Made During a Review (PDF) This workflow will walk reviewers through the process of accessing comments made during a review.