1 / 19

Continuing Review for Convened and Expedited IRB Applications

Continuing Reviews must be submitted annually for all Convened and Expedited IRB applications. Failure to do so will result in the expiration of the study. This guide explains how to create a Continuing Review application in the IRB system.

cyrusa
Download Presentation

Continuing Review for Convened and Expedited IRB Applications

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. JHM eIRB Continuing Review

  2. Continuing Review • Continuing Reviews must be submitted annually and are required for all Convened and Expedited applications. • Continuing Reviews must be submitted prior to the expiration date. Failure to do so will result in the expiration of the study. • If you wish to continuing active enrollment or active follow-up of participants, you must submit a New Application for review and approval by the IRB.

  3. Create Continuing Review • Select My IRB Studies from the left navigation bar. • Locate the Approved tab on the Investigator Home Page. • Scroll down to the New Applications section. • Select the name of the currently approved study. • This opens the application workspace.

  4. Create Continuing Review • Under Current Activities, locateCreate Further Study Action. • Click Create...

  5. Create Continuing Review • Select the type of FSA to be createdand select Continue. • You can only select one FSA at a time. • Once the FSA has been created, you can return to this screen, following the previous steps, to select a different type of FSA.

  6. Continuing Review Screens • Complete each screen. • Click Continue to save the current screen and advance to the next screen.

  7. * Required Field • The red asterisk * indicates a required field that must be completed. • You will not be able to submit the application until all required fields on each screen have been answered.

  8. Help Link • The Help Link icon appears beside each question. • Click the icon to access IRB Regulatory Guidelines and Policies and download forms/templates.

  9. Finalize Continuing Review • Click Finish • This returns you to the application workspace. • Finish indicates the last page of application. • You may continue to edit the continuing review until it is submitted.

  10. Continuing Review Workspace • Application Waiting To Be Submitted • Purple text disappears upon submission. • Study Vital Statistics • Displays important information such as the study title, date submitted and last scheduled review. • Current Status • Displays the current state of the change in research in the submission/review process.

  11. Continuing Review Workspace • IRB Review Items • Displays the review date, review type, outcome, and letter sent. • Workspace Tabs • History Log • Reflects completed activities. • Reviewer Notes • Displays a collective list of IRB issues that require a response by the study team.

  12. Continuing Review Workspace • Left Navigation Bar • Divided into two sections. • 1- Project Editor • View/Edit gives access to the existing application. • Printer Friendly displays a scrollable version of the application with the option to print. • View Differences lists changes made to the change in research since the previous submission.

  13. Continuing Review Workspace • Left Navigation Bar • Divided into two sections. • 2 - Current Activities • Displays a list of activities that may be completed.

  14. Continuing Review Workspace • View the Current Status box to monitor progress through the IRB review process. • Select View/Edit to open an existing application. • Use the Current Activities to submit/withdraw the application. • View the History Log to track activities. • Use the Review List to retrieve the review outcome letter.

  15. Continuing Review Complete • Click Submit when the application is ready to IRB review (only the PI will have the Submit activity).

  16. Continuing Review Workspace • Select My Home to return to the Investigator Home Page.

  17. Locate/Track Continuing Review • Option 1: • Select the appropriate tab. • Scroll down to the Continuing Review (Green)section. • Select the application name. • This opens the application workspace.

  18. Investigator Home Page • Option 2: • Select the Approved tab on the Investigator Home Page. • Scroll down to the Continuing Review section. • Select the study name. • This opens the application workspace.

  19. Application Workspace • Select the Further Study Action tab. • Scroll down to the Continuing Review section. • Select the application name. • This opens the application workspace.

More Related