IRBManager


To login, click here:

IRBManager Login

 

Note: This will open up the login screen to IRBManager. GVSU users: click on the large GVSU logo in the middle of the login screen. This will open up a pop-up window where you will enter your GVSU network ID and password. (No separate username/password is required for IRBManager.) After entering your GVSU credentials, you will be routed to the IRBManager system.

 

To view the most recent version of the Instruction Manual, click here.


System Roll-out Updates

Please read this section for important information related to the conversion from IRBNet to IRBManager. This section will be updated periodically as new information becomes available over the next several weeks.

 

Use of IRBNet [Last updated 10/10/17]:

GVSU's access to IRBNet has ended, and all previous IRBNet submissions have been processed. If a previous IRBNet submission was returned to you for clarifications/additional information, the revised submission must go through IRBManager. 

 

Conversion of Existing IRBNet Studies [Last updated 11/1/17]:

*Update* (11/1/17): The final data conversion is scheduled to run the evening of 11/1/17 (overnight). All studies from IRBNet should be in the system by 11/2/17, as well as documents from the IRBNet system.

Over the next week, ORCI will be cleaning up the Contacts that get transferred over during this final data conversion. In cases where a nickname was used in IRBNet, duplicate Contacts will be created during the conversion. (For example, if a PI used John Smith as the name for one IRBNet study, but used Jonathan Smith for another study, two separate Contacts will be created in IRBManager. Only the Jonathan Smith study will be accessible at sign-in; the John Smith study will not be accessible until ORCI merges the two Contacts.)

ORCI will also be going in and cleaning up the study information on the projects in IRBManager. There are over two thousand studies being transferred from IRBNet, and this clean-up has to be done manually, so this will likely take many months.  

 

Original Post (9/25/15): The initial data conversion was run on 9/23/17. This conversion process created a study in the IRBManager system for each protocol number and links that study to personnel captured in the IRBNet system (e.g., PI, submitter, Authorizing Official). The study will appear in the "Studies" section for each person linked to the study. (Note that project personnel who were only listed on the PDF application form, but not somehow linked in the IRBNet system, will not be linked to the study in IRBManager through this conversion.)

Converted studies can be found under the “Studies” section in the middle of the IRBManager Dashboard (homepage)—there is a link to click on either “active studies” or “total studies” (which includes active and closed studies). Note the conversion of data was limited by the data available to us through the IRBNet system, and because of this, a handful of studies did not get created in IRBManager and/or did not get all of the study information properly transferred. We are aware of this, and we will be running additional data conversions over the next couple of weeks to try to capture as much of this data as possible.  

Important: Continuing Review, Amendment, Closure, and Adverse Event forms can only be submitted from active studies in the IRBManager system. If you need to submit one of these forms in the next 2-3 weeks for one of your studies, but that study is not listed in IRBManager, please contact our office at rci@gvsu.edu.

If you do not see one of your studies listed at this time, but do not need to submit any documents/application forms for it in the next month, there is no need to contact our office at this time. The final conversion will be run in early-to-mid October after all of the pending IRBNet submissions are processed. If the study is still not showing at that point, please contact our office at that time. This webpage will be updated after the final conversion is completed.

We will also be converting all the attachments from IRBNet (anything uploaded to the system) as part of the final data conversion process. So you will currently not see any attachments associated with the converted studies in IRBManager, but they will be added soon.

 

Notifications of Expiration Dates [Last updated 9/25/17]:

Studies that have already been converted from IRBNet to IRBManager are currently setup with automatic reminder notifications. As noted above, we are limited by the data provided by IRBNet, so if the data did not come over correctly from IRBNet, it may not trigger the notification correctly (or at all). We will be monitoring expiration dates manually within our office over the next several months as a second check to ensure data was transferred properly, but please be extra vigilant in monitoring expiration dates for your studies. (We suggest putting reminders in your Outlook Calendar when a study gets initial approval.) If you have a study about to expire for which you do not receive a notification reminder from IRBManager, please let us know at rci@gvsu.edu, as that will help us troubleshoot any problems in this area.


Tips for Using IRBManager

Below are some tips for using IRBManager and some small procedural changes that have occurred in the Office of Research Compliance and Integrity (ORCI) as a result of the conversion to IRBManager.

 

General

  • “xForm” refers to any form submitted to ORCI (e.g., new protocol submission, amendment, etc.).
  • Click “Start xForm” to see a list of forms available. Note that study-specific forms (e.g., Continuing Reviews, Amendments, Closures, and Adverse Event forms) are only available when clicking the “Start xForm” from within an active study page. (Make sure you are on the general study information page, and not a specific event within that study.)
  • The Collaborator button within a form gives individuals access to the FORM only, it does not add them as study personnel to a protocol. (The latter is done through the questions on the form.)
  • If a PI gives collaborators “submit” rights, when the collaborator presses submit, the xForm will get routed to the PI. Only the PI can advance the Form to the Authorizing Official/ORCI.
  • Names of Authorizing Officials are built into the system; you do not need to add AOs as collaborators on your protocol. When you press submit, the form will get routed to the AO.
  • Whenever you open a new form, it adds that form to your list of “unsubmitted” forms. The form will remain there until you submit it or delete it. (So if you see several unrecognized forms in your unsubmitted xForms list, it is likely you previously opened a new form without realizing it.)
  • To see all the questions on a form, click on the print icon to the left of the form name on the “Start xForm” page. (Note this displays everything in the form—questions, as well as conditioned information that may be shown when a particular response is entered to a conditioned question.)
  • Expiration dates for your training certificates can be tracked using the "My Expirations" link in the user Settings menu (available from the Dashboard). IRBManager will send automatic expiration reminders 30 days prior to the certificate expiring.

 

Human Subjects Research (HRRC)

  • The exempt and expedited/full review submission forms have been combined into a single “HRRC New Protocol Submission Form.” Based upon the answers provide in the form, you will be prompted to answer either the exempt- or expedited/full board-related questions.
  • Training certificates can either be attached to the “HRRC New Protocol Submission Form” or sent to ORCI via the “Training Certificate Upload Form.”

 

Conflict of Interests (COI)

  • The PDF version of the “Conflict of Interest Disclosure and Certification Form” will eventually be discontinued. This form is now available in IRBManager.
  • The new version of this form is designed to capture potential COI issues for ALL of your university research. For HRRC submissions, the COI form only needs to be submitted once per year provided there are no changes in Significant Financial Interests (SFIs) throughout the year. Therefore, a new version of the COI form is not needed with each HRRC application if you have an active (less than 1 year old) form on file and there have been no changes in SFIs since the form was submitted. (If SFIs do change throughout the year, you are required to submit an updated COI form within 30 days of the change.)
  • The Office of Research Compliance and Integrity is working with the Office of Sponsored Programs to streamline the COI submission for OSP applications as well. An update should be announced shortly. For now, please continue to use the paper-based COI form for OSP submissions.

 

Animal Research (IACUC)

  • The Three-Year Renewal Application Form has been discontinued. If you are submitting a renewal, please use the “IACUC New Protocol Submission Form.”
  • Each new protocol will be assigned a new protocol number; legacy protocol numbers for renewal applications will be phased out over the next three years.


Page last modified November 1, 2017