Insight FAQs

Questions

Answers

Study Staff section: Why are my staff showing as not having training completed?

Potential reasons AT THIS TIME:

- They have sponsored accounts (and should be removed and listed in external staff spreadsheet in “Attachments”) – UPDATE: This was just fixed!

- They are students/residents (in process of being fixed in insight)

- Their CITI account was not matched correctly to their Insight account (maybe had multiple CITI accounts, maybe never logged in via SSO).

- Might have wrong CITI (Sociobehavioral instead of Biomed or vice-versa, or not have GCP).

Sounds like sponsor issues may have been resolved. But we don’t want it to look like typical member. We want everyone to be added to the “external” team member list.

Haven’t found issue with students.

Printing Forms: We are normally required to print out the submission form and history of the submission. Is this still possible in the INSIGHT system and if so, how can we access them? If not, then we will have to change our processes.

In the top of the application there is a Download View Full Application. It will download a PDF version if the application.

CR: Will there be a just a “Create Continuing Review” submission ONLY option instead of just having the “Create Continuing Review or Continuing Review/Amendment” option in the HUMANs Module eventually? There will be times when there isn’t an amendment to submit with the CR.

If you click the main option, you do not have to do the Amendment part. For migrated studies, the system will force you to fill in all missing questions before submitting the CR, though.

Note: If you Create a Continuing Review and do not make changes to the protocol, it will submit as a Continuing Review. If you make changes to the application within the submission, it will change to a CR/AME.

CR: Also, I was able to delete some of the pages that did not pertain to this CR (like Study Population and Recruitment). These seemed more like Study Start-up questions. Please advise if that is allowed? Is deleting the forms we do not need?

We can’t accept most CR’s/AM’s right now, but in future, please do not delete any basic forms like these for migrated studies. The only forms you should delete are ones that are truly not applicable to your study, e.g. a form for minors when you’re only enrolling adults (though that shouldn’t appear). Remember to update the Study Overview form if you make major changes to your study, since that is what triggers the other forms. Even if you are not obtaining consent, we still need the Informed Consent form, because that gathers info about waivers of consent. We know it’s a lot to fill in the first time working in Insight, but it will become the study’s complete current record in the new system.

Things still in eIRB: I created a new protocol in eIRB on 30JUL2025 which is still under review in eIRB, when will it be transitioned into Insight?

We think starting on 9/19, but not sure exactly how long the migration will take once it starts.

We are still trying to wrap up. It’s possible we will have to tell you that it will have to be resubmitted in Insight.

CR for Migrated Studies: We worked on a CR for an eIRB study and the only option we were able to choose was “Create Continuing Review or Continuing Review/Amendment”.  When I did that, it gave me this huge list of forms that had multiple things missing. They were not separated so the Amendment Form was embedded, and you cannot skip or remove/delete it. Not sure if that is a glitch but…there is nothing being modified so I am unsure how to answer this page/form. Also, the questions for CR seem to be super extraneous and not sure if that is a glitch as well. They seem more like, again, Study Start-up/New Submission questions.

For migrated studies, the system will force you to fill in all missing questions before submitting the CR, but in the future, you won’t have to make any Amendment as part of this type of submission.

Can the forms be made smarter where they do not refresh the screen after each selection? If we have to make 2 changes (i.e. Change the role and then change Contact or not), that is 2 screen refreshes for just one line. It would be easier if we could make the changes and then hit SAVE.

That would be up to Insight to update their base product, but we provide them with suggestions!

Under the Organization for staff, can this be cleaned up as people seem to have more than one entry?

It would be good to get examples. A staff member shouldn’t be listed twice. We do have one bug where there are some records with more than one PI that we are tracking.

Can something be done on the backend for all staff that are not assigned as the PI and Regulatory, to be changed to Viewer? The PI and Regulatory should be the only staff that have the Manage Role.

Create a Staff Update transaction, update their access to VIEW and submit. PI will sign off and it will automatically approve.

CEDE studies: Why is Lay Summary required for previously approved studies and Ceded Studies? Emory IRB's role in Ceded studies is to confirm Ancillary Reviews are in place, study staff are appropriately GCP trained, and local Emory site language is correctly incorporated into the consent form. Emory IRB's Board is not reviewing the study. Can we revert to "N/A" for Ceded Studies?

For previously migrated, it’s because insight will become the record for the study for all future reviews.

For CEDE: Required for Epic interface.

Can the application be returned to the Submitter prior to PI signoff?

Yes, PI can send it back to submitter.

Can the short title be included in the searchable page?

We are asking for that as well; up to Insight to make the change.

Can the Home Page default to the last item end user worked on?

It should do that.

Is there a timeline for CITI mapping to study staff?

We have the mapping, but glitches for sponsored accounts, students. Everyone needs to have logged into CITI via SSO as well and take the right modules for the type of study. Sometimes people have multiple CITI accounts which would need to be straightened out (e.g. merging their accounts).

What information migrated from the Huron system into the Insight system?

A smattering of SmartForm questions, title, “lay summary”, and attachments. One last batch of attachments was supposed to be added after go-live (which we didn’t realize so wasn’t communicated), and that was put off until we do the current “fix” for migrated studies. The remaining attachments for correctly migrated studies will be added, and all attachments for the ones that need fixing will be reloaded.

In the study staff section, when saving, can the application stay on the same page? (When adding staff, if you are on page 2 or 3 and change the permission of a study staff member from "manage" to "view", the form returns to page 1 automatically. This is time consuming, especially when you have over 70 study staff on your studies.)

Same as prior question.

Are supplemental protocols required for chart reviews (or any other studies)? What is the rationale for these?

Not for chart reviews/secondary data analyses. Or exempt.

Can we get an email notification when PI or Ancillary Dept submit/sign off on the application?

Requires updates. Note: All folks listed as Contacts on the staff page will get notifications when it’s sent back from the IRB.

How is eCOI review prompted in the system?

On the PI Sign-Off there is a form for noting PI COI as well as for any members of the study team. That triggers the ancillary review.