eIRB Vocabulary - Project Workflow and User Roles

1. eIRBPrincipal Investigator & Study Staff eirb.wfubmc.edu

2. eIRB Vocabulary • Project – An instance of one of the 4 main project types – Application, Amendment, Continuing Review, Safety Event. Each project has its own workspace that allows people to interact with it and monitor its progress through the review process. • Activity – An action that a person can perform on a project. Submit Application is the first activity that is performed on an Application. Activities create an entry in the history log and often cause a change in state. Activities also send email notifications. • State – The current status of a project. When a study team creates a new Application, it is in the state “Presubmission”. State changes are caused by activities. When a new Application is submitted by the PI, the Application’s state changes from “Presubmission” to “Section Review”

3. More eIRB Vocabulary • History Log – A list of events, most recent on top, that charts the movement of the project through the review process. The history log will only display the events that the current user is allowed to see. • User Role – A designated role in the system that determines the level and type of access a person has in the system. A person may have multiple user roles such as Board Member and PI. In this case the user will have two personal workspaces customized to allow the person to perform the actions of each role. • Personal Workspace / My Home – A personal area with a layout customized based on user role. Study Staff workspaces are designed to initiate and monitor projects while IRB Staff workspaces are designed to process projects in the review process.

4. Last One… • Project Workspace – A homepage for the project that allows people to interact with it and monitor its progress through the review process. The Application workspace is the base of operations for all study specific actions. Child projects (Amendments, Continuing Reviews, Safety Events) have workspaces that are accessible from the parent Application.

5. Workflow • Please note…the eIRB system does not change the time it takes for the review process. Specialty Review IRB Office PI Submits Application Section Review GCRC Cancer Center *Ancillary Committees i.e. Radiation Safety Comm., Downtown Health Plaza *Ancillary Committee approval does not stop the review process until full approval is given.

6. PI’s w/ Great Coordinators • How do you hit go?? • Login • Select study • Under “My Activities” Select “Submit Application”. • Complete the Conflict of Interest Disclosure and hit OK. • Can be done on the sunny beaches of the Caribbean through Citrix Portal!!

7. DEMO • My Inbox • Creating a New Application • Attaching a Document • Submitting an Application • Agreeing to Participate

8. Responding to Reviewer Concerns • During the course of the review process in eIRB, the study team will be required to address the concerns of reviewers. These include Section Reviewer Concerns, Specialty Reviewer Concerns, IRB Administrator Concerns and Board Concerns. In each case, the process is the same. • When concerns are sent by a reviewer, the application will be returned to the inbox of all study team members with an indication in the history log that concerns have been added. An email will also be sent to study team members alerting them that concerns need to be addressed. • Use the link in your inbox or on your email to enter the application’s workspace:

9. Responding to Reviewer Concerns • Click the Concerns tab to see what concerns have been added. • Once the changes have been made on the application (if required), use the “Click here to respond” link to summarize your response to the reviewer. Select the appropriate category and give your response. • When finished, exit the application forms and return to the application workspace. Use the “Submit Response to Reviewer” activity to return the application to the Helpful Hint: Every time you make a change, hit save or change will be lost!

10. Informed Consent Forms • eIRB requires all informed consent documents to contain specifically programmed merge fields in the document footer. After you submit your application and informed consent documents the eIRB system automatically adds information to these fields during the review and approval process creating an electronic “Approval” stamp and makes the documents read-only. Informed consent documents that have not been created with or modified to include the appropriate fields will not be approved. • Assent documents should be modified following the same procedures used for informed consent documents.

11. If you are using informed consent documents provided by the Sponsor 1. Copy the following Text Box Stamp. DO NOT CHANGE OR MODIFY THE TEXT BOX STAMP. To copy, right mouse click on the Text Box Stamp and select copy. «ApproveAt» «ApproveBy» IRB Number: «IRBNo»«Approved» «ApproveDate» Version Valid Until: «ExpireDate»

12. Informed Consent Forms • Open the informed consent document. Open the footer in the informed consent document. • Paste the copied Text Box Stamp into the footer of the informed consent document. If the Text Box Stamp does not paste directly into the footer area you can drag it into the footer by clicking and holding down the left mouse button. Position the Text Box Stamp so that the right boarder of the Text Box Stamp is at the right margin of the document. • Save the informed consent document which now contains the Text Box Stamp. 5. Upload the informed consent document containing the Text Box Stamp into the eIRB application.

13. If you are using the Wake Forest University School of Medicine Informed Consent Template • Open the Informed Consent Template. • Modify the body of the Informed Consent Template as required for your study. • DO NOT CHANGE OR MODIFY THE TEXT BOX STAMP LOCATED IN THE TEMPLATE FOOTER. • Save the informed consent document. • Upload the informed consent document to the eIRB application.

14. Who Can Submit What?? • New Protocol Application = PI ONLY • Amendments & Continuing Reviews = PI’s and Coordinators • Safety Events (Adverse Events, Prot. Deviations) = Any Study Team Member

15. Cool Features • Accessible from anywhere through Portal. • No more guesswork. Whole study team is on the same page. Plus status checks. • Email notifications. Includes warnings (CR – 60 & 30 Day). • No more “iffy” mail delivery!!