This chapter describes eProst processes available only to members of an Institutional Review Board
Steps to Reviewing/Approving a Submission Are:
1. You will receive an eProst-generated e-mail notification that there is a study pending action from you.
2. Log into eProst (Chapters 1 and 2)
3. Click on IRB Member role from within the Home Workspace page (Chapter 3).
4. Click on the title of the study you wish to access under the My Inbox tab on the Home Workspace.
NOTE: The My Inbox tab will only list those submissions to which the user has been assigned as a primary or secondary reviewer for the convened IRB meeting and expedited and exempt studies where the user has been assigned as a reviewer. Expedited and exempt submissions will be identifiable by a current state of Expedited Review in Progress or Exempt Review in Progress, as appropriate
5. Click on the View Protocol button on the top left of your screen to view the SmartForm in a multipage format. The user may use the CONTINUE and BACK buttons to navigate within the SmartForm as well as the Jump To: functionality as described in Chapter 5. Alternatively, you may click on the Printer-Friendly Version button if you wish to combine all of the pages within the SmartForm into one complete web page.
6. The HSRO staff member who worked with this study prior to assignment to the IRB will add an activity titled Forwarded To Expedited Reviewer or Forwarded To Exempt Reviewer (as appropriate) in the study history with any necessary documents, such as guidance documents and checklists included in the event entry. The comments will be visible in the Study Workspace from the History tab and any attached documents will be accessible by clicking on their filenames.
7. Users will be presented with specific activities based on their roles and the permissions assigned to them within the system. These activities include:
· Edit Consent Form
· Submit Expedited Review (or Submit Exempt Review)
· Request External Consultation
· Study Team Communication Log
· Internal Communication Log
NOTE: The Edit Consent Form and Request External Consultation have been included for the ongoing and future development of the eProst system. This guide will be appropriately updated once these functions are fully tested
8. If the user, as a reviewer, wishes to communicate with the Principal Investigator and other study contacts, he/she may do so by clicking the Study Team Communication Log activity. This will provide a location for the IRB Member to input any comments they wish and upload any applicable documents into the study workspace as well as alert the PI and study contacts via email that there is a new message available within eProst.
NOTE: Any comments uploaded into the Study Team Communication Log will be viewable by any user who has permission in eProst to access the Study Workspace
9. If the reviewer wishes to communicate with the HSRO and the other members of the IRB, he/she may do so by clicking the Internal Communication Log activity. This will provide a location for the IRB Member to input any comments they wish and upload any applicable documents into the study workspace. Currently, the HSRO recommends that IRB Members upload any modified study documents (such as the Informed Consent Form) into an Internal Communication event for future review by the convened IRB.
10. Once the user is prepared to complete their review of the Expedited or Exempt submission, he/she will then click the Submit Expedited Review or Submit Exempt Review activity as appropriate. eProst will then present the user with a form asking their recommendation and additional information such as the approval category, risk determination, and other information as required by federal and state regulations and UM Policies.