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Chapter 13: IRB Member's Guide to Reviewing Studies Requiring Approval by the Full IRB


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This chapter describes eProst processes available only to members of an Institutional Review Board

Steps to Reviewing/Approving a Submission as a Primary or Secondary Reviewer 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. Full board submissions will be identifiable by a current state of IRB Meeting Assigned.  If you wish to read those protocols that will be reviewed at the meeting, please reference the instructions provided in the second part of this chapter

 

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 record an Internal Communication Log event 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 Log and any attached documents will be accessible by clicking on their filenames.

NOTE:  The Internal Communication Log is only visible to IRB Members and HSRO staff


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 

·           Request External Consultation 

·           Study Team Communication Log 

·           Internal Communication Log 

NOTE:  The Edit Consent Form and Request External Consultation activities 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.

Steps to View a Submission That Will Be Reviewed By the Convened IRB Are:

 

1)    Log into eProst (Chapters 1 and 2).

 

2)   Click on the IRB Member role from within the Home Workspace page (Chapter 3).

 

3)    Click on the Upcoming Meetings tab on the Home Workspace. The user will now have access to view all currently available meetings by Date, Start Time, Name and Committee. (c.f. Figure 9)

 

4)    Click on the name of the meeting you wish to view to be taken to the Meeting Workspace. (c.f. Figure 10)

NOTE:  In addition to allowing the user to access any studies that will be reviewed by the convened IRB at a given meeting, the Meeting Workspace also allows users to Confirm Attendance or Decline Attendance at the referenced meeting

 

5)    Click on the ID (eProst number) of the study you wish to access from the list of Electronic Agenda Items available from the Agenda tab of the Meeting Workspace. The user will be taken to the appropriate workspace for the submission.  Any communication events will be visible from the History tab. The user may read the submission’s SmartForm by clicking the appropriate link to either View Protocol or view the Printer-Friendly Version.  Any documents included with the SmartForm are accessible by clicking their titles from either of these views of the submission SmartForm or by clicking on the Documents tab of the Study Workspace.



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Figure 12:  The "Upcoming Meetings" tab of the "Home Workspace"



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Figure 13:  The "Meeting Workspace"



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