1. Introduces ePIRATE electronic Portal for Institutional Research at ECU East Carolina University Office for Human Research Integrity

2. ePIRATE Training Objectives East Carolina University Office for Human Research Integrity After this training you should be able to: Log into ePIRATE Create your user profile Navigate ePIRATE workspaces based on your user role(s) Navigate the Smart Forms based on your user role(s) Perform tasks associated with your role(s) Identify changes to the IRB submission process Locate resources for ePIRATE on the OHRI website

3. ePIRATE New Terminology East Carolina University Office for Human Research Integrity Study State (i.e. IRB Staff Review, Exempt Review in Progress, Assigned to IRB Meeting, etc) User Role Workspace Smart Form Legacy Application (currently approved studies) Jump Menu Reviewer’s Notes (only available to IRB members and Department Approvers) Ancillary Review Project Types Study Amendment Continuing Review Reportable Event

4. ePIRATE Login East Carolina University Office for Human Research Integrity

5. ePIRATE Registration East Carolina University Office for Human Research Integrity

6. Create your ePIRATE Profile East Carolina University Office for Human Research Integrity After registering you must create your profile You will receive an email after you register which will have a link that will take you directly to your profile page, or You may click on “My Home” in the upper right corner of the ePIRATE Home screen to access your “home” screen, once there you may click on the “Profile” tab which will result in your name being displayed, then click on your name to open your profile page Click on “Edit Researcher Profile” in upper left corner to begin completing your profile You will be asked to enter your CITI module completion date as a part of your profile, this means it will follow you for each study. Update this as needed

7. Navigating Your Workspace(s) East Carolina University Office for Human Research Integrity Investigators & Research Personnel Department Approvers, Deans, Associate Deans and Directors Faculty Mentors / Supervisors (of student researchers) IRB Members Ancillary Approvers HPAs & Other Administrative Approvers Consultants

8. Navigating Your Workspace(s) East Carolina University Office for Human Research Integrity TIPS Each “role” has its own workspace If you have more than one role in the conduct of human research, you must select the role in which you wish to work in order to display the workspace for that role. To do this, select your role under “My Roles” located on the left side of your “My Home” screen. Your workspace in-box items need your attention (you will also receive notifications at your email address listed at the time of registration) Your workspace in-box & IRB tabs should be used to monitor your studies Each study has its own workspace Click on a study to enter its workspace to view the submissions and approvals for that study, access documents for the study as well as view information about the study’s “current state” etc.

9. Navigating the Smart Forms East Carolina University Office for Human Research Integrity Help text (found in the shaded box on the right side of the screen) Jump Menu Continue Button Saving Text boxes Drop down menus Radio buttons Add/Select Menus (documents, people, departments, etc)

10. ePIRATE Correspondence East Carolina University Office for Human Research Integrity You will receive email notifications from UMCIRB@ecu.edu at various times throughout the submission and review processUMCIRB@ecu.edu Some correspondence will also be documented and stored in the history of your ePIRATE study workspace Expect correspondence from : Your study team members People who will need to approve your study IRB Staff IRB reviewers

11. New OHRI / IRB Processes East Carolina University Office for Human Research Integrity Only after all research team members have “Agreed to Participate” can the PI “submit” the study. All ancillary approvals must be obtained before the submission is forwarded to the IRB A new required ancillary approval has been added - ITCS Security IRB-approved consent documents will have a system generated approval and expiration date and will be accessible within the study workspace. No more submission deadlines; studies will be placed on the IRB agenda on first come first serve basis with a limit of 12 items per agenda IRB Administrative staff “ownership”, if you have questions about your study contact the IRB administrative staff owner

12. ePIRATE Legacy Application Tips East Carolina University Office for Human Research Integrity When you log into ePIRATE after the “go-live” date of August 1 your current IRB approved studies will be in the “Legacy Approved” state. The only information that will be in ePIRATE about your study is the IRB #, study title, PI name and study expiration date. Upload only the most recent IRB approved version of your study information, forms & documents Make sure you have all of your current documents for uploading IRB Documents Request Form Start early – you don’t have to wait until you have an amendment, continuing review or other reportable event

13. ePIRATE Resources East Carolina University Office for Human Research Integrity

14. ePIRATE Resources East Carolina University Office for Human Research Integrity

15. ePIRATE Resources East Carolina University Office for Human Research Integrity http://www.ecu.edu/rgs/irb/ 252-744-2914 UMCIRB@ecu.edu ePIRATE Training Site Link: http://ecudev.clickcommerce.com/TRAINING2